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This export was generated by user [email protected] at account BioInformatics Inc. on 11/19/2019 from IP address 23.240.184.87. © 2019 Science and Medicine Group Using Interactive Document Server technology from Publish Interactive November 2019 © Science and Medicine Group Instrument Business Outlook: Volume 28 — Issue 15 IBO (Instrument Business Outlook) is a twice-monthly newsletter aimed at providing decision-makers with the latest and most complete information available on the life science and analytical instrument industry, and lab product markets. IBO delivers the latest curated industry news, information and trends, as well as SDi data and analysis to deliver the maximum in industry insight with a minimum time investment for executives and investors. Publication date: Friday, 15 November 2019

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This export was generated by user [email protected] at account BioInformatics Inc. on 11/19/2019 from IP address 23.240.184.87.

© 2019 Science and Medicine GroupUsing Interactive Document Server technology from Publish Interactive

November 2019

© Science and Medicine Group

Instrument Business Outlook: Volume 28 — Issue 15IBO (Instrument Business Outlook) is a twice-monthly newsletter aimed at providing decision-makers with the latest and most complete information available on the life science and analytical instrument industry, and lab product markets. IBO delivers the latest curated industry news, information and trends, as well as SDi data and analysis to deliver the maximum in industry insight with a minimum time investment for executives and investors.

Publication date: Friday, 15 November 2019

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Table of Contents

TABLE OF CONTENTS ......................................................................................................................................2

IBO FALL 2019 BUSINESS CLIMATE REVIEW: US-CHINA TRADE LOOMS LARGE ................................................5

CHINA-US TRADE’S THREATENING INSTABILITY .............................................................................................................6

THE CHALLENGES OF BREXIT......................................................................................................................................7

IT BLOSSOMS .........................................................................................................................................................9

MARKET-BASED CONCERNS ....................................................................................................................................10

THE M&A WAY ...................................................................................................................................................11

OPPORTUNITIES ABOUND .......................................................................................................................................11

EMPLOYMENT CONCERNS .......................................................................................................................................11

AMP 2019 HIGHLIGHTS: FASTER CANCER DETECTION, IMPROVED TREATMENT SELECTION AND MORE EFFICIENT WORKFLOWS ...............................................................................................................................13

EXECUTIVE BRIEFING ....................................................................................................................................16

QIAGEN CONSIDERS STRATEGIC ALTERNATIVES .........................................................................................................16

ABCAM ADDS TO CONJUGATION AND PROTEIN LABELING PORTFOLIO .............................................................................16

GYROS PROTEIN TECHNOLOGIES SOLD ......................................................................................................................17

HITACHI FOCUSES ON ELECTRON MICROSCOPY FOR GENE THERAPY ................................................................................17

HORIZON DISCOVERY TO SELL ANIMAL MODEL BUSINESS .............................................................................................18

THIRD QUARTER RESULTS: BRUKER, DANAHER, ILLUMINA, PERKINELMER, THERMO FISHER SCIENTIFIC AND WATERS .......................................................................................................................................................19

BRUKER’S SEMICONDUCTOR METROLOGY PRODUCTS CONTINUE TO EXPERIENCE DECLINING SALES ......................................19

DANAHER’S EUROPEAN SALES DECLINE DUE TO LIFE SCIENCES AND ENVIRONMENTAL & APPLIED SOLUTIONS DEMAND ...........21

SALES OF ILLUMINA SEQUENCING CONSUMABLES SURPASS THE $500 MILLION MARK .......................................................23

SLUGGISH SALES FOR PERKINELMER’S APPLIED MARKET AND DIAGNOSTIC BUSINESS DOES NOT DETER COMPANY’S POSITIVE

OUTLOOK FOR THE YEAR ........................................................................................................................................25

THERMO FISHER REVENUES SOLID DESPITE DIVESTMENT OF ITS ANATOMICAL PATHOLOGY BUSINESS....................................27

UNEXPECTED SALES DECLINE FROM US PHARMACEUTICAL CUSTOMERS IMPACT WATERS’ QUARTERLY SALES ........................29

MARKET PROFILE: ELECTRON SPIN RESONANCE/ELECTRON PARAMAGNETIC RESONANCE (ESR/EPR) ..........32

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LEADING VENDORS................................................................................................................................................33

LARGEST MARKETS................................................................................................................................................33

INSTRUMENT COST................................................................................................................................................33

INDUSTRY WATCH........................................................................................................................................34

GOVERNMENT......................................................................................................................................................34

ENERGY...............................................................................................................................................................34

FORENSICS...........................................................................................................................................................35

REGION WATCH ...........................................................................................................................................36

SOUTH AFRICA .....................................................................................................................................................36

CHINA.................................................................................................................................................................36

HUNGARY............................................................................................................................................................37

NEWS ...........................................................................................................................................................38

BROAD-BASED COMPANIES .....................................................................................................................................38

Company Announcements...........................................................................................................................38

Sales and Orders of Note.............................................................................................................................39

SEQUENCING........................................................................................................................................................39

Company Announcement ............................................................................................................................39

Product Introductions..................................................................................................................................41

Sales and Orders of Note.............................................................................................................................43

MS & LC/MS .....................................................................................................................................................43

Company Announcements...........................................................................................................................43

Product Introductions..................................................................................................................................45

Sales and Orders of Note.............................................................................................................................45

BIOPROCESS ANALYSIS ...........................................................................................................................................46

Company Announcements...........................................................................................................................46

Product Introductions..................................................................................................................................47

Sales and Order of Note ..............................................................................................................................47

PROCESS ANALYSIS ................................................................................................................................................47

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Company Announcements...........................................................................................................................47

Product Introductions..................................................................................................................................47

Sales and Orders of Note.............................................................................................................................48

BOTTOM LINE...............................................................................................................................................49

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IBO Fall 2019 Business Climate Review: US-

China Trade Looms Large

For the fall 2019 business climate review, IBO has once again surveyed leading scientific and lab product trade organizations (see IBO 10/31/18) to learn about their members’ priorities and concerns. The five organizations, each country based, are made up of lab instrument and product suppliers and represent a worldwide view, including the US, Europe and Japan, of the laboratory tools industry.

As with last year, the participants this year are US-based trade association ALDA (Analytical, Life Science and Diagnostics Association); French laboratory instrument and equipment organization FABRILABO; GAMBICA, the UK trade association for instrumentation, control, automation and laboratory technology; JAIMA (Japan Analytical Instruments Manufacturers’ Association), which represents Japanese analytical instrument makers; and German industry association SPECTARIS, whose members include medical, optical analytical, biological, laboratory, and ophthalmic technology companies.

The economic repercussions of the US-China trade dispute and the possibility of Brexit remain the most pressing issues for these organizations’ members, as both short-term and long-term uncertainty disrupt business operations and sales prospects. At the same time, IT and digitalization offer tremendous opportunities for organizations’ members that are only beginning to be realized. A number of issues, from employment to sustainability to M&A, are also at the forefront of members’ minds.

Trade Association Priorities for 2020

ALDA Recruit the next ALDA president and CEO to replace the retiring president and built on ALDA’s achievements and successes.

Provide valuable insights on how digital technologies will impact the life science and diagnostics businesses over the next three years and applications relevant to our industry.

Identify emerging and next generation markets for our industry’s products and services.

Expand diversity and inclusion.

FABRILABO EUROM II (the European trade association of scientific instruments and equipment manufacturers) meetings are priorities for our organization as they enable us to share the concerns of our industry so that they can be addressed at the EU level. The next EUROM II meeting is on Thursday, April 2, 2020, at analytica, followed by a gathering with the American (LPA, ALDA), Japanese (JAIMA) and Korean (KASIA) trade associations.

GAMBICA Grow our membership.

Provide more and improved services for members.

Take greater advantage of digital marketing.

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JAIMA Strengthen collaborations between industrial, academic and government organizations, as well as domestic and overseas networks: By strengthening our networks, we will be able to identify and sort out issues, implement countermeasures, revitalize domestic industries and expand business overseas, which will in turn lead to future development.

Promote standardization: We will work towards promoting the international standardization of analytical instruments.

Provide technical information, and conducting special courses, etc.: We will promptly obtain relevant technical information such as domestic and international standards and regulations, then make recommendations and announcements whenever necessary.

Promote international industrial cooperation: We will cooperate with European and American trade associations to make efforts in handling analytical instruments for RoHs regulations, which are being strengthened in Europe and places elsewhere.

SPECTARIS SPECTARIS initiated a working group “Connected laboratory devices” where we work on a joint communication standard based on OPC UA (Open Platform Communications Unified Architecture). Smart devices need to be able to communicate unrestricted and operate independently. They should be integrated simply and intelligently in the laboratory environment of the customer, centrally controlled and deployed in flexibly configurable laboratory processes. We will present a first draft at analytica 2020 and are happy to share our ideas and plans with our American partners!

The industry for analytical and laboratory technologies is an important part of the German economy. However, their perception in politics and the general public is limited. Far too seldom, this technology sector is seen as the key to solving major societal challenges, such as health, nutrition and the environment. SPECTARIS is preparing a study which demonstrates that the safety and quality of drinking water and other food only can be guaranteed through analytical and laboratory techniques. This is to make clear that people benefit daily from the innovative products of these techniques—perhaps without knowing it.

Source: Science and Medicine Group

China-US Trade’s Threatening Instability

China’s economy, the US-China trade dispute and associated macroeconomic ramifications are a focus of attention for the trade associations. “The concerns of greatest interest to members of ALDA continue to be: 1) the continuing tariff and trade dispute with China and the potential impact on global trade, and 2) the future prospects for the US and global economies,” said ALDA President Mike Duff. This uncertainty involves the timing of the trade war’s resolution, as well as the longer-term impact on China-US relations and global trade in general. “China is an important market for many companies and a related concern is how internationally focused companies can maintain their China business in the current environment,” he added.

The possible long-term effects of the trade conflict could include slower economic growth for both China and the US and reduced capital investments in the countries. “The effects may be reversed to an extent there is an interim agreement on the US-China tariff dispute, which could get the trade relationship back on track—although several speakers at recent ALDA meetings have cautioned that a landmark trade deal is virtually impossible at this time, and that the US and China may be entering an era of national competition,” asserted Mr. Duff.

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Birgit Ladwig, manager of Analytical and Laboratory Equipment for SPECTARIS, detailed for IBO how the China-US dispute is affecting SPECTARIS members. “The USA and China are the most important destination countries of the German manufacturers,” she said. “More than 25% of the total exports are accounted for from these two countries.” In addition to the threat to exports, operations have been complicated for German lab tools suppliers that have production facilities and/or customers for these products in both countries. “Laboratory equipment is especially listed on the US-American lists, but China has listed some laboratory equipment products as well. For example, microscopes are one of the products to be found on the lists,” continued Ms. Ladwig.

To address such effects, German firms are changing their supply chains and distribution channels. For example, explained Ms. Ladwig, “The German Chambers of Commerce, which issues certificates of origin, also have reported a significant increase in company requests for certificates of origin stating that their products do not have a Chinese or US-American origin when exporting to the other respective country.” The trade dispute is also impacting German firms’ appetite for investment in both countries, according to her, as companies await greater certainty and predictability.

Ms. Ladwig is doubtful about a reversal of the trade conflict’s impact. “As the mitigation of the effect of the US-China trade dispute has caused affected companies to adapt their supply chain, we assume that companies expect the trade dispute to last for a longer period of time,” she remarked. “Due to these circumstances, from our point of view, not all effects and adaptation carried out due to the trade conflict can be reversed after the conflict has been resolved.”

GAMBICA, however, expects some mitigation of the effects in a more general sense. Jacqueline Balian, head of GAMBICA’s Laboratory Technology Sector, told IBO, “The impact has been on general trade. It could still be reversed with sensible negotiations. “Nonetheless, one of the organization’s top three current business concerns for its members is a worldwide economic downturn related to the trade battle.

JAIMA’s comments to IBO also reflect its members’ worries. “The trends in the Chinese market are a particular cause for concern amid the ongoing and intensifying trade disputes between the US and China,” remarked Takeshi Kawamoto, chairman of the International Affairs Committee at JAIMA. He maintained that the economic fallout of the trade dispute is pervading economies worldwide. “In addition, the recession in Asia and Europe that is affected by the protectionist movements of the US as well as the countries involved is also a cause for concern,” he said.

Francis Pithon, vice president of FABRILABO, expressed the concerns of EU instrument companies. Among these is the desire by China as well as the US to support local companies and maintain their market share, which is a concern among organization members as access to new technologies may be limited. “Without a strong local market, it is difficult for a company to have access to the world market,” he stressed.

The Challenges of Brexit

Also at the forefront of major instrument organizations’ agenda, as with a year ago, is the ongoing Brexit crisis. Not surprisingly, GAMBICA listed Brexit-related issues as 2 of its top 3 current business

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concerns. Specifically, the organization identified the uncertainty caused by Brexit as well as the ongoing disruption to stocking levels. As Ms. Balian explained, this involves “the cyclical ramping up of stock levels at both the supplier and customer end to deal with the potential effects of Brexit. Then the subsequent running down of stocks—until the next Brexit date approaches!” Brexit is also one of top business challenge listed by Ms. Balian for 2020, and relatedly “maintaining market share in exports” and “managing short-term variability of demand.”.

Ms. Ladwig detailed to IBO some of the longer-term implications of Brexit on business stability both now and in the future. She described a situation in which the UK would have to recertify products if it loses its association with EU’s Notified Bodies (NBs, which evaluate EU product conformity). With Brexit looming, UK manufacturers and NBs are being urged to transfer related certification and product labeling so that sales may continue unabated, according to her.

Border issues affecting product shipments could also be an area of particular consequence. “Additionally, SPECTARIS sees challenges for the UK customs border control to fulfil the requirements,” commented Ms. Ladwig. “It is expected that the UK Border Force will receive a fivefold increase in customs declarations after Brexit—up to 250 million a year,” commented Ms. Ladwig. Thus, members are anxious about the chances of a smooth transfer and whether they will need greater inventory capacity in UK in order to continue product supplies during the transition, according to her.

Commenting on Brexit, Mr. Pithon told IBO, “Among the different concerns of our industry, Brexit is one of them as it weakens the EU.” Yet he also sees other possibilities. “It could become an opportunity if the remaining states took the decision to establish new structures for a stronger EU, which could lead to an enlargement step in the future.” For UK companies, he cautioned that Brexit would result in the UK needing to negotiate new trade agreements with all the countries previously covered by its EU membership.

For the EU itself, Mr. Pithon remarked, “The development of scientific instruments and equipment is strategic for the EU as it wishes to promote sustainable development, industries, quality products goods and health systems for which tools must be developed to measure and analyze the effectiveness of this policy.”

For SPECTARIS members, trade issues reach beyond Brexit to include other sanctions. Among these, Ms. Ladwig listed, “US secondary sanctions for non–US resident companies and persons (e.g., CAATSA) affecting business with Russia and Iran.” Passed into law in 2017, CAATSA (Countering America's Adversaries Through Sanctions Act) enacted US sanctions on Iran, North Korea and Russia. “Other sanctions against European investments are in preparation (e.g., DASKA, DETER) and are contradicting our faith in free trade,” she acknowledged. The US’ DASKA (Defending American Security from Kremlin Aggression Act), if enacted, would impose sanctions on Russia, while DETER (Defending Elections from Threats by Establishing Redlines Act of 2018), another bill before the US Congress, also targets Russia with further sanctions.

Ms. Ladwig called out non-tariff trade barriers, citing regulations and their burden on small and medium-sized companies (SMEs). The cost, time and labor involved with meeting new regulations can strain companies’ productivity, said Ms. Ladwig.

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IT Blossoms

Outside of economic and political worries, the organizations representing the lab instrument and product sector are wrestling with the possibilities and changes created by a new era for digital and IT technologies. JAIMA named adapting to information and communication technology as one of its members’ challenges for 2020. Mr. Kawamoto detailed these challenges as “expanding business for products and services that offer new added value, such as being able to support big data and composite measurements, as well as being able to use AI for digital innovations such as making advancements in deep learning technology.”

Information and communication technologies is 1 of the top 3 business opportunities for JAIMA members next year in the life sciences. In particular, Mr. Kawamoto cited the use of AI for data analysis to improve drug therapy and treatment. Another challenge he listed was “making efforts towards discovering new scientific knowledge as a result of the ‘visualization’ that is made based on big data.”

Digitalization also made GAMBICA’s top three list of business challenges for 2020, with Ms. Balian summing up the challenge as “taking advantage of Laboratory 4.0 and the move to digitization.”

ALDA members concur. Mr. Duff told IBO that the use of digital technologies in the R&D, healthcare and medical segments have the potential to improve research efficiency, as well as to advance drug development and management of supply chains. This also includes new opportunities for data visualization and the application of AI to large data sets. “Like many companies, members of ALDA are trying to understand how big data, AI/machine learning, blockchain, IoT, etc., will be used by our user markets in the future: the impact on their research/discovery activities, manufacturing, clinical trials, etc., and the implications/opportunities for our industry as suppliers of ‘tools’ and technologies,” he said.

FABRILABO members also view IT as an opportunity and a challenge. “To stay at the forefront of communication and AI technology is essential for both the manufacturing of scientific instruments and the processing of results, as well as for machine-to-machine communication and automation,” he proposed. “Lab automation, communication protocols between instruments, data handling and laboratory information management systems are all key challenges for EU companies.” As he elaborated, trends include SMEs’ use of open source solutions and thus a market limited by commercial offerings mostly from non-EU companies. He asked, “Could a European standard be an answer to this challenge? Standards are efficient levers of new technology adoption and often used by companies.” He described French involvement in CEN (European Committee for Standardization) 332 committees for laboratory equipment, which was a priority of FABRILABO.

Relatedly, Mr. Pithon expressed concerns about the construction of new labs and maintenance of older labs and their compliance to standards. “FABRILABO‘s priority in this case is to publish a guide where guidance related to the compliance to standards can be found,” he remarked

SPECTARIS also views the wave of IT and digital changes as one of its members‘ top 3 business opportunities in 2020. “Getting analytical systems, biotech and laboratory technology fit for ‘Laboratory 4.0’ is going to be a big challenge for the next few years. Workflow integration,

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connectivity and data integrity are paramount in the process,” remarked Ms. Ladwig, But the challenges are indicative of the scope of the opportunities. “Just to name a few, big chances lie in the development of standardized interfaces, efficient automation and robotic solutions and the integration of AR/AI,” she commented. “In the laboratory of the future, processes and structures will need to be redesigned. Customers should be involved earlier, more closely and more consistently in the process of drawing up ideas and developing products.” Such improvements could include designing products to better meet customer needs.

Consequently, for customers as well as vendors, there are numerous areas of interest and choices to be made. Summarizing one aspect of this, Ms. Ladwig told IBO, “Last but not least, digitalization will also open up new business models. Although some smart services are already available for customers, these mostly take the form of information platforms for service parts, accessories and consumables, along with digital manuals—and usually they are ‘for free’ instead of ‘for a fee.’” Consequently, new business can be found for service offerings. “Evolving smart services into Smart Services Business Models, for which the customers are willing to pay, offers huge potential,” she surmised.

Market-based Concerns

Mr. Kawamoto broke down JAIMA members’ top three current business concerns according to end-market. In the nanotech and materials sector, currently these are centered on instrument demand; for example, “diversification of the uses and need for semiconductor devices, as well as maintaining industrial infrastructure and basic infrastructure required for daily life,” he maintained. Thus, opportunities for 2020 lie in “enhancements in batteries and semiconductor devices resulting from the development of electric vehicles in the automotive industry, and the trend in the need for analytical technology and equipment, which is associated with these enhancements,” he commented.

In the environmental and energy sector, Mr. Kawamoto reported members’ current concerns about global warming, as well as air, groundwater and soil pollution and water quality. In this area, he also pointed to “trends in supply chains and mobility systems for environmentally conscious forms of fuel.” In 2020, environment-related concerns for JAIMA members will be sustainability and the related development goals of business. But Mr. Kawamoto also addressed these concerns in his list of 2020 business opportunities, which will encompass the need for environmentally conscious products informed by growing awareness of environmental conservation. He also noted environmental regulations in China and Europe as an opportunity.

SPECTARIS also referred to the 2020 business opportunities involving climate protection and environmental sustainabilty. “On the one hand, this is an opportunity because new areas of application emerge and existing business areas become even more attractive, such as the environmental analysis. Furthermore, energy-efficient products or solutions that enable a more sustainable production for the customers are also offering new potential,” explained Ms. Ladwag. But she also cautioned, “On the other hand, it is a challenge to optimize the sustainability of the production processes in the companies themselves and to fulfill the increasing legal and documentation requirements.”

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In the life sciences, current concerns for JAIMA members are focused on”making advancements in preventive medicine, early diagnosis and treatment, point-of-care testing and personalized medicine,” according to Mr. Takamoto. These challenges are expected to persist into 2020 in the form of “innovating for diagnostics and drug discovery and progress in the regenerative and personalized medicine markets,” he reported.

ALDA also discussed diagnostic opportunities for its members. “Over the past few years, many members of ALDA have expanded their presence in the diagnostics markets and prioritized investments in diagnostics companies, and this trend is expected to continue,” explained Mr. Duff. But other markets are also of interest. “Recent ALDA meetings have examined emerging user markets such as synthetic biology, immunology and cell therapy, and single-cell biology,” he remarked

The M&A Way

Like these new scientific fields, M&A will also present opportunities in 2020 for ALDA members, according to Mr. Duff. “M&A will continue as interest rates remain low and as many larger companies look to acquisitions to gain access to technologies they have been unable to or have chosen not to develop internally, and to expand and fill out their product portfolios.” This also includes purchases of small companies to expand product development and global growth.

Mr. Pithon advanced a view of M&A’s effects on smaller companies. “Another concern is the major changes in the structure of the scientific instrument industry from an industry peopled mainly by SMEs to one in which as few as 15 companies share 75% of the market,” he stressed. SMEs will have to compete in new ways. “New players with strong logistics and distribution skills are entering the market, and their mastery of information and communication technologies may be a threat or an opportunity for our SMEs members,” he concluded.

Opportunities Abound

In discussing its members’ 2020 prospects SPECTARIS called out emerging markets, although they are not without obstacles. “Finding suitable sales structures and partners is a challenge, but the efforts show success,” remarked Ms. Ladwig. “For example, in 2018 the exports to India increased by 6%, to Brazil by 20% and to South Africa and Thailand by 10%.” Business opportunities in 2020 for its members cited by GAMBICA were exchange rates, and growth in services and productivity.

Employment Concerns

Mr. Takamoto discussed a country-specific challenge for JAIMA members. He commented on “working in-line with the ‘work-style reforms’ in Japan to make operations in each industry efficient.” As he described it, work-style reform “is a program by the Japanese government with a

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package of legislation to improve labor productivity through innovation and changes of work style by diversifying and increasing the flexibility of the manner in which employees work.”

According to Ms. Ladwig, in Germany, employment concerns are considered a challenge. “The lack of skilled employees in Germany remains a problem and affects all types of business sectors. In particular, for SMEs which are located outside of the capital cities, it is very difficult to attract well-qualified employees for a decent salary,” she explained. She noted the acute demand for digital expertise. In response to these employment issues, she said Germany companies are increasing employee training.

Challenges listed by Ms. Ladwig in 2020 include consolidation among manufacturers and customers. “While the concentration on the side of manufacturers doesn´t unsettle the SPECTARIS members too much, they watch the concentration of customers with growing concerns,” she commented. “Especially the application-specific shift and reorganization within the big laboratory groups crossing (inner European) borders [that] leads to changing processes of procurement and a decrease in demand.”

Another business concern in 2020 described by Ms. Ladwig is online analysis. Although not new, she advised, “[T] he demand of customers for equipment which can be used in online processes is growing extremely [fast] nowadays.” This was evident at a recent event, according to her. “At the SPECTARIS trend event Lab.Vision in May 2019 at BASF, BASF clearly stated the shift from the laboratory to the process. The manufacturers have to face this change and adapt their equipment to these customers’ demand,” she concluded.

A myriad of issues are at play for lab tool companies worldwide, according to trade organizations, which is not new for the business world or the field of science. These organizations are looking ahead, keenly aware of their members’ goals and options.

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AMP 2019 Highlights: Faster Cancer Detection, Improved Treatment Selection and More Efficient Workflows

AMP 2019 Highlights: Faster Cancer Detection,

Improved Treatment Selection and More

Efficient Workflows

Early detection is key to improving treatment outcomes for most cancers, but despite advancements, the challenge of early detection remains. The NIH estimated that in 2018 alone, 1,735,350 new cases of cancer were diagnosed in the US and over 600,000 people died from the disease. These developments argue for vigilance and constant innovation of instruments used in cancer diagnostics and therapy. Not surprisingly, instrument vendors at the Association for Molecular Pathology 2019 Annual Meeting & Expo (AMP), held November 7-9 in Baltimore, Maryland, showcased innovations designed to improve detection time and testing relevance. Organizers estimate the number of scientific attendees at 2,200.

A notable product introduction was Thermo Fisher Scientific's same-day NGS system, the Ion Torrent Genexus. Thermo Fisher highlighted the durability of the Genexus’ design and IT features, including reporting and documentation of all aspects of the sample run. Andy Felton, vice president of Product Development at Thermo Fisher, spoke with IBO about the system. He said the Genexus is designed to make NGS on par with immunohistochemistry (IHC) systems in terms its influence on oncologists’ decisions. "At the current time, the IHC result comes in a few hours, and the next generation sequencing test is generally outsourced and comes in weeks," he said. "By then, the treatment recommendation has been made. If you can perform NGS on site, it can also be part of the process." To do this, Genexus boasts a workflow time of less than 24 hours for some cancer type and same day with most others. This speed, Mr. Felton said, is due to the system’s use of a greatly improved clonal amplification process that reduces processing time from 14 hours to 3 hours.

Reporting and IT features were also enhanced from previous Ion Torrents systems. The Genexus' reporting now provides two levels of detail—one for a basic report the oncologist can download, which is generally used to make therapy recommendations for patients, and another more detailed report with the clinical significance of results. Any and all system process events that might need to be recorded, such as an empty reagent bottle, are stored in the IT system. The product has not yet undergone FDA review. Thermo Fisher expects to price the Genexus at $290,000, with the cost per sample varying but in the range of $300–$600 per sample.

Additionally, Thermo Fisher announced a collaboration with Owlstone Medical to further develop Owlstone’s Breath Biopsy offerings. Using non-invasive breath sampling, the collaboration will advance the early diagnosis of cancer and other diseases through the discovery and validation of new biomarkers. The solution will utilize Thermo Fisher’s Q Exactive GC Hybrid Quadrupole-Orbitrap MS system. Goals include the integration of the solution into Owlstone’s metabolomic study services.

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At the show, Illumina made news with the debut of a liquid biopsy NGS offering for oncology. As of 2019, over 40 companies are active in the global market for liquid biopsy diagnostics and monitoring tests. The market is expected to surpass $1.5 billion by 2023, according to a recent Kalorama Information report, with a CAGR of 27.9% over the next five years.

Illumina’s TruSight Oncology 500 ctDNA is its first liquid biopsy solution for detecting cancer biomarkers. According to the company, TruSight provides labs with the flexibility to analyze both tissue and liquid biopsy samples. Consequently, it can uncover biomarkers using liquid biopsy when tissue samples are limited or unavailable, or it can complement tissue results by detecting biomarkers in circulating tumor DNA (ctDNA). The assay analyzes both tumor mutational burden and microsatellite instability (MSI). Illumina also introduced TruSight Oncology 500 High-Throughput, which can run up to 192 tissue samples on its NovaSeq 6000 system. A Friday workshop entitled "Enabling Comprehensive Genomic Profiling from FFPE & Liquid Biopsy Samples on a Single High-Throughput Sequencing Platform," presented by Brandon Selby and Brandon Kocher, PhD, both senior product managers for Oncology at Illumina, was well attended.

Agena Bioscience showcased its combined RT-PCR and MS system. The company's UltraSeek chemistry is designed to be an economical method for validating mutations of interest identified through NGS and RT-PCR, to confirm or rule out borderline results. The company said that following whole-exome sequencing, targeted detection on its MassARRAY system has been proved to confirm low-threshold mutations.

The company also released the VeriDose CYP2D6 CNV panel, designed to provide pharmacogenomics (PGx) testing programs with a more accurate and efficient way to analyze CYP2D6 copy number. Combining PGx genotyping and copy number detection in the same workflow is a game changer from a lab efficiency perspective, according to Agena. Previously, genotyping and copy number detection required separate setups, instrument runs and analyses. The results then had to be combined. The new test allows labs to maximize resources by setting up one protocol to generate the required information all at once.

Promega announced at AMP a global collaboration with Merck for companion diagnostics (CDx). The collaboration will develop Promega’s MSI technology as an on-label, solid tumor CDx for use with Merck’s anti-PD-1 therapy, KEYTRUDA. The presence of MSI represents phenotypic evidence that DNA mismatch repair (MMR) is not functioning normally. Cells with abnormally functioning MMR are unable to correct errors that occur during DNA replication and consequently accumulate errors.

The global collaboration will initially seek regulatory approval for the Promega MSI CDx in the US and China. Plans to seek approvals in additional territories may follow. "We are pleased to join the companies in [the] companion diagnostics field and help patients receive the right therapy," said Heather Tomlinson, head of Clinical Diagnostics for Promega, in an interview with LabPulse.com. Promega stated the agreement is non-exclusive and indicated it will seek other CDx opportunities.

Bio-Rad Laboratories used the meeting to announce the release of its QX ONE Droplet Digital PCR System. The system automates the company's ddPCR technology into a single integrated instrument that is designed for drug development and manufacturing QC, as well as other critical test environments. The QX ONE automates all the steps of the ddPCR workflow, including droplet generation, amplification and reading. It offers a 5-plate capacity and the ability to analyze up to 480 samples a day. The system can detect 4 colors simultaneously for 8-plex CNV detection, 5-plex

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mutation detection and 4-plex gene expression detection. According to Bio-Rad, the QX ONE System is sold out for early access this year. Additional shipments are being scheduled for 2020.

Mission Bio displayed its Tapestri Platform, which the company calls the first and only single-cell multi-omics platform that is capable of simultaneously providing both genotype and phenotype data from the same cell, across thousands of cells. It features a high-throughput capacity of up to 10,000 cells. The system can directly assess the clonal architecture of a sample and uncover the true distribution of genotypes and their segregation patterns across subclones. These subclonal mutations can escape current treatments, and NGS alone can miss what is happening in rare cell within a population.

Workflow and sample preservation were keys in the developments at AMP. QIAGEN announced new Multimodal Panels for its QiaSeq solutions. According to QIAGEN, the Panels can simultaneously detect DNA variants, RNA fusions and gene expression levels from one sample, and do so in nine hours. Input can be as low as 10 ng of total nucleic acid. Qiagen said the product eliminates the need for two separate, time consuming, inefficient and costly workflows for library preparation from separate DNA and RNA samples. Both libraries are generated from the same sample input and sample utilization and, in turn, sampling induced bias is also reduced. This enables labs to conserve samples of limited availability for further downstream applications.

RNA expression data for use in tumor and tumor microenvironment profiling can take a long time and usually requires a significant sample. Yet understanding the profile is critical for drug treatment and therapy. To this end, NanoString Technologies showcased its immunofluorescence-based GeoMx Digital Spatial Profiler (DSP) at the show (see IBO 4/15/19). The system combines standard immunofluorescence techniques with digital optical barcoding technology to perform highly multiplexed, spatially resolved profiling experiments.

The assay relies upon antibody or RNA probes coupled to photocleavable oligonucleotide tags. After hybridization of probes to slide-mounted FFPE tissue sections, the oligonucleotide tags are released from discrete regions of the tissue via UV exposure. This is useful as FFPE is a common form of sample preparation. Released tags are quantified using the company’s standard nCounter assay, and counts are mapped back to tissue location, yielding a spatially resolved digital profile of analyte abundance.

The company said the system can capture tissue morphology and select regions of interest for high-plex profiling, and that this increases the likelihood of capturing rare events often missed by typical "grind and bind" assays. GeoMx DSP can quantify up to 96 proteins and over 1,000 RNA targets with spatial context, and process 10–20 slides per day. Workflow is matched with sample preservation, as the company said its immunoflourescence and optical barcoding processes are non-destructive.

Next year’s AMP show will be held November 17–21 in Vancouver, Canada.

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Executive Briefing

QIAGEN Considers Strategic Alternatives

New York, NY 11/13/19; Venlo; The Netherlands 11/15/19—Following a report by Bloomberg that Thermo Fisher Scientific was considering buying QIAGEN, QIAGEN has confirmed that it has received “indications of interest.” In response, the company stated that it is reviewing strategic alternatives, including discussions with the interested parties. QIAGEN stated that the discussions are not assured of resulting in an official offer. QIAGEN shares hit a 17-year low last month, according to Bloomberg, as the company reduced its quarterly guidance and long-time CEO Peer Schatz stepped down (see IBO 10/15/19). Thermo Fisher Scientific declined Bloomberg’s request for comment.

QIAGEN stock rose 7.6% on the day of its announcement. QIAGEN’s annual revenues topped $1.5 billion last year and could lead to one of Thermo Fisher’s largest acquisitions in its history. The Bloomberg report also indicates that other companies may be in QIAGEN, whose boasts a foothold in the life science sample preparation and selected diagnostics segments as well as a well-established brand and leading positions in automation and nucleic acid purification. Thermo Fisher’s last acquisition that topped one billion dollars was its purchase earlier this year of Brammer Bio for $1.7 billion (see IBO 3/31/19).

Abcam Adds to Conjugation and Protein Labeling Portfolio

Heidelberg, Germany and Cambridge, UK 11/11/19—Life science research tools firm Abcam has agreed to acquire publicly listed German firm Expedeon’s Proteomics and Immunology business, including Innova Biosciences and TGR BioSciences, for €120 million ($132 million at €0.91 = $1) in cash. The business provides conjugation technologies and offers the Lightening-Link and CaptSure brands. In 2018, revenues for the Proteomics and Immunology business totaled €13.1 million ($15.4 million at €0.85 = $1), with EBITDA of €1.0 million ($1.2 million) (see IBO 5/15/19). “Abcam’s growth strategy is committed to building out conjugation and assay capabilities,” said Abcam CEO Alan Hirzel. “Expedeon’s portfolio of products and technology, combined with Abcam’s antibody and protein strengths, will put our company in a strong position to address the growing need for antibody conjugation and multiplexing solutions.”

Expedeon CEO Dr. Heikki Lanckriet commented, “The remaining business will focus on new attractive growth markets. With our strong intellectual property (IP) and genomics business know-how, we are determined to build a leading DNA manufacturing firm taking a novel, cell-free approach that offers significant advantages over the classic fermenter-based method and unlocks a growing market in the gene therapy field.”

Abcam anticipates the purchase to be accretive within 12 months. The deal is subject to an Expedeon shareholder vote, which will be held December 19. The retained businesses will account for 15% of Expedeon’s assets in terms of consolidated financial statements, and the company will change its name and branding.

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The companies had been partners, with the acquisition allowing Abcam to build up its proprietary portfolio of research kits. Expedeon acquired TGR Biosciences, which provides protein capturing technology, last year (see IBO 5/15/18). Expedeon, under its prior name Sygnis, purchased Innova Biosciences and its Lightening Link protein and antibody labeling technology in 2017 (see IBO 5/15/17).

Gyros Protein Technologies Sold

Lakewood, CO 10/31/19—Publicly held Mesa Laboratories, which provides instruments and consumables QC applications, has purchased Gyros Protein Technologies (GPT) from AP6, Ampersand Capital and individual shareholders for $180 million. Based in Sweden, GPT sells immunoassays and peptide synthesizers for biotherapeutic development and manufacturing. The purchase is expected to add $37–$40 million in annual sales, including 55% recurring sales, to Mesa’s total revenue as well as produce double-digit revenue growth. GPT will be part of Mesa Laboratories’ new Biopharmaceutical Development platform. “We believe that The Mesa Way approach to continuous improvement will help the GPT team to continue to rapidly scale both commercially and operationally,” commented Mesa Laboratories President and CEO Gary Owens. Mesa Laboratories supplies products through five divisions: Sterilization and Disinfection Control, Biopharmaceutical Development, Instruments, Cold Chain Monitoring and Cold Chain Packaging. GPT is expected to have gross mid- to high 60s percentage profit margins percentages, excluding the impact of purchase accounting and integration expenses. Adjusted operating income is expected to be in the mid-teens as a percentage of revenues in the first 12 months.

Mesa Laboratories declined IBO’s request for comment. According to a Mesa Laboratories’ presentation, over 70% of GPT’s sales are derived from its immunoassay business and the remainder from sales of peptide synthesis instruments. GPT’s immunoassay platform is based on a microfluidics disk for use with nanoscale volumes. Applications in bioprocess testing include downstream impurity testing and product titer quantitation during development.

NASDAQ-listed Mesa Laboratories reported that fiscal 2019 revenues grew 7.2% to $103.1 million. Its Sterilization and Disinfection Control division provides products and services, including biological indicators. The Instruments Division’s offering includes data loggers, medical meters, gas flow calibration systems and torque testing equipment. Cold Chain Monitoring division sales consist of wireless monitoring systems, while the Cold Chain Packaging division sells thermal packaging products. However, the company plans to exit the Cold Chain Packaging division by March 2020.

Hitachi Focuses on Electron Microscopy for Gene Therapy

Tokyo, Japan 11/7/19—Hitachi High-Technologies has acquired shares in Swedish firm Vironova for an undisclosed amount. Vironova offers TEM data analysis software and services for drug companies. A focus of the partnership will be services for developing viral vectors for gene therapy applications using TEM. Hitachi High-Technologies announced in its press release, “Through this capital alliance, we aim to provide cutting edge solutions by combining Vironova's regulatory

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compliance and automated measurement and analysis software, developed based on their experience gained from their existing business, with Hitachi High-Tech's high-quality, user friendly TEM.”

Viranova offers the portable electron microscopy services as well as sells the MiniTEM system for nanoparticle analysis. TEM and cryoelectron microscopy services offer characterization of vaccines, gene therapy and drug delivery particles such as viruses and liposomes, including viral clearance testing. The company was established in 2005.

Horizon Discovery to Sell Animal Model Business

Cambridge, UK; Indianapolis, IN 11/8/19—Horizon Discovery, which supplies gene editing and modulation products, has agreed to sell its In Vivo business to Envigo, a provider of research models, for a “nominal consideration.” The business provides genetically engineered rodents, including xenograft mouse models for CRISPR screens. In 2018, the business generated £4.6 million ($6.1 million at £0.75 = $1) in sales and an EBITDA loss of £1.3 million ($1.7 million).

"In our recent results statement, we highlighted the fact that In Vivo was facing some challenging market headwinds,” said Horizon Discovery CEO Terry Pizzie. “Whilst we have been working hard to optimize In Vivo's performance, we recognize that we are subscale in this market and that it would be challenging for the Group to establish a market leading position in this segment.”

Envigo President and CEO Dr, Adrian Hardy stated, “We already provide the industry’s broadest range of research models to the global biopharma, academia, government and other life science organizations, so we can provide the necessary scale and commercial infrastructure to more broadly market genetically engineered rodent models and associated services.” The companies will collaborate to offer services for CRISPR screening. The deal is expected to close by year end, with all of the In Vivo business’s employees anticipated to join Envigo.

The purchase will expand Envirgo’ research model portfolio to include transgenic models, including gene-edited and custom gene-edited rodents. The In Vivo business was small for Horizon Discovery, making up only 8% of its total 2018 revenues of £58.7 million ($78.3 million at £0.75 = $1). In the first half of 2019, In Vivo sales fell 11.5% in constant currency to £2.5 million ($3.3 million). The sale also reduces Horizon Discovery’s service offerings.

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Third Quarter Results: Bruker, Danaher, Illumina, PerkinElmer, Thermo Fisher Scientific and Waters

Third Quarter Results: Bruker, Danaher,

Illumina, PerkinElmer, Thermo Fisher Scientific

and Waters

Bruker’s Semiconductor Metrology Products Continue to Experience

Declining Sales

Third quarter Bruker Scientific Instruments (BSI) sales increased to make up 91% of total company revenues (see Bottom Line). System sales grew 16.6% to account for 71% of total BSI revenue, while Aftermarket sales jumped 4.5%. On a constant currency basis, the company’s total sales rose 14.0%.

Bruker Q3 FY19

Rev. (M) Chg. Currency Acq./Div. Organic Chg.

Total $521.1 11.7% -2.3% 6.4% 7.6%

Bruker Scientific Instruments $471.8 13.1% -1.9% 5.9% 8.6%

Source: Science and Medicine Group

As for end-markets, for the first nine months of 2019, there was stable demand from the academic and government, biopharma and microbiology markets, partially offsetting slow sales growth in the industrial and applied markets.

Bruker Operating Margin Q3 FY19

Adj. Op. Profit Chg. Adj. Op. Margin Chg. (bps)

$87.8 27.1% 16.8% 19

Source: Science and Medicine Group

The following outlines both quarterly and the first nine months financial results for BSI's three business segments. Financial results for nine month sales are in constant currency.

For the first nine months, BSI scientific instrument orders grew in the mid-single digits, while consumables sales grew by over 20%.

BioSpin's third quarter sales rose in the low single digits, including the sale of a 1.0 GHz NMR system. For the first nine months of 2019, BioSpin sales rose in the mid-single digits to $422 million, driven by robust instrument and aftermarket sales, as well as a small contribution from software acquisitions. Another sales highlight was nine month revenue recognition of two 1.0 GHz NMR

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systems, which produced moderate sales growth due to legacy pricing. Bruker also noted that it shipped its first 1.1 GHz NMR system. BioSpin’s preclinical imaging systems experienced a sales uptick.

CALID experienced a quarterly revenue increase in the low teens due to strong sales of microbiology and MS products. For the first nine months, the segment’s sales rose in the high teens to $447 million and grew double digits on an organic basis. Revenue drivers were microbiology applications, the MALDI Biotyper platform and MS product lines. Another sales highlight was a significant revenue contribution from the (see IBO 8/31/19). In contrast, molecular spectroscopy revenue was flat.

Nano quarterly sales rose high single digits on an organic basis, thanks to broad-based demand across the division's portfolio. Despite the sales improvement on both a year over year and sequential basis, due to the slow demand in the industrial market as well as sluggish sales of the semiconductor metrology product line, the company does not expect Nano's sales growth to continue at this pace. For the first nine months of 2019, Nano sales grew in the high teens to $462 million, and rose in the low single digits on an organic basis. Once again, contributions from acquisitions as well as consistent demand from the academic and government end-market, especially for the advanced the x-ray product line, boosted the division's sales. Other sales highlights included robust sales for the division's Nano analysis tools, such as EDS and micro-XRF, as well as strong sales for Nano surface tools due to contributions from acquisitions. In contrast, Nano experienced weak sales in the industrial end-market and for its semiconductor metrology product line.

Bruker by Division Q3 FY19

Rev. (M) % of Rev.

BioSpin $143.7 28%

CALID $158.2 30%

Nano $169.9 33%

BEST $52.5 10%

Source: Science and Medicine Group

Geographically, Asia Pacific delivered mid-teens sales growth on an organic basis, including strong sales in Japan, both on a quarterly and year-to-date basis. China experienced high single-digit revenue growth, despite a slower pace of orders partly due to paperwork delays. Europe reported a single-digit increase in sales, while North America’s sales grew in the low single digits and declined slightly on an organic basis. Rest of World reported solid sales, except for Latin America.

Bruker by Region Q3 FY19

Rev. (M) Chg. % of Rev.

US $135.5 1.0% 26%

Germany $57.7 28.5% 11%

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Rest of Europe $121.0 5.6% 23%

Asia Pacific $158.5 17.9% 30%

Other $48.4 25.4% 9%

Source: Science and Medicine Group

Bruker reaffirmed its full-year revenue growth guidance of 7%–8%, including 4.5%–5.5% organic growth, but revised its constant currency revenue growth forecast to 10%–11%, up from 9.5%. Acquisitions are expected to increase revenue by approximately 5.5%, an increase from the prior guidance of 5%. Currency is now expected to have a 3% negative impact compared to the previous estimate of a 2.5% negative impact.

On an organic basis, the company predicted BioSpin's fourth quarter sales to rise in the mid-single digits; CALID's fourth quarter sales to grow in the high single digits to low teens; and Nano's fourth quarter revenue growth to increase low single digits. Product wise, Bruker forecast its semiconductor metrology’s full-year sales to decline double digits on an organic basis. The product line accounts for 5% of Bruker's total revenues.

Danaher’s European Sales Decline Due to Life Sciences and

Environmental & Applied Solutions Demand

Danaher by Division Q3 FY19

Rev. (M) Chg. Currency Acq./Div. Organic Chg.

Life Sciences $1,695.6 6.2% 1.5% -1.0% 6.5%

Environmental & Applied Solutions $1,080.5 0.6% 1.5% 0.0% 2.0%

Source: Science and Medicine Group

Danaher’s 3.8% revenue growth, with core growth of 5.0%, or 6.0% excluding the spun-off Dental business sales (see IBO 9/30/19), included a 0.5% increase in growth from acquisitions and a 1.5% decrease due to currency (see Bottom Line). This is the eighth consecutive quarter of 5% or better core revenue growth for the company. For the third quarter, the company’s total revenues were led in part by 6.2% revenue growth for the Life Sciences business. Recurring revenue represented 64% of Life Sciences sales. Environmental and Applied Solutions increased 0.6%, with recurring revenue representing 55%.

Selected Danaher Divisions Operating Margin Q3 FY19

Op. Margin Chg. (bps) Core Chg. (bps)

Life Sciences 20.2% 61 100

Environmental & Applied Solutions 23.7% 7 10

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Source: Science and Medicine Group

This is the sixth consecutive quarter in which the Life Sciences segment sales has recorded high single-digit or better core revenue growth. Beckman Life Sciences was the primary revenue driver, delivering double-digit core revenue growth due to broad-based demand across all major regions and product lines, especially newly launched products.

SCIEX revenue slightly declined as the result of a tough comparison to 10% sales growth in the third quarter of 2018. Geographically, the business experienced robust sales in the High Growth Markets, yet recorded weak sales in North America and Western Europe. Specifically, tepid sales in North America were attributed to order delays in the second half of the third quarter. Also, the consolidation of some small and mid-sized reference labs created sales headwinds. In contrast, the academic market delivered solid sales in North America and China.

Also, within the Life Sciences segment, Pall revenue grew in the high single digits, driven by demand across all major regions. Within Pall, the biotech and aerospace product lines experienced significant sales increases, partially offsetting weak microelectronics sales. Other sales highlights included double-digit core sales growth for Pall’s single-use technologies, and gene and cell therapies product lines. Also, the Pall Biotech business delivered double-digit core revenue growth for the sixth consecutive quarter.

Integrated DNA Technologies' (IDT) sales rose double digits, including broad-based demand across all regions and strong sales for NGS and synthetic biology product lines.

Geographically, Life Sciences’ Western Europe sales declined, partially stemming from weak Leica Microsystems sales growth.

Selected Danaher Divisions by Region Q3 FY19

Life Sciences Environmental & Applied Solutions

Rev. (M) Chg. % of Seg. Rev. Rev. (M) Chg. % of Seg. Rev.

North America $637.2 9.1% 38% $465.5 5.9% 43%

Western Europe $444.1 -0.7% 26% $252.8 -1.8% 23%

Other $149.2 10.9% 9% $32.5 4.8% 3%

High Growth Markets $465.1 7.9% 27% $329.7 -4.8% 31%

Source: Science and Medicine Group

Within the Environmental and Applied Solutions segment, water quality sales grew mid-single digits, including low single-digit revenue growth for Hach. Geographically, Hach recorded strong sales in North America and Western Europe, partially offsetting declining sales in China due to a tough comparison related to the initiative of China’s surface water law, Policy 61.

Danaher now forecasts its full-year core revenues to increase 4.5%, compared to the previous 5% guidance. Also, the company expects SCIEX sales to improve in the fourth quarter. The company did not provide revenue guidance for the fourth quarter.

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Sales of Illumina Sequencing Consumables Surpass the $500 Million

Mark

Illumina by Product Line Q3 FY19

Rev. (M) Chg. % of Rev.

Total Company $907 6.3%

Consumables $600 8.1% 66%

Instrument $146 -5.8% 16%

Service & Other $161 12.6% 18%

Source: Science and Medicine Group

Illumina’s third quarter revenues grew 6.3% and were led by approximately 12% sales growth in its sequencing business, partially offsetting a nearly 24% sales decline in its microarrays business (see IBO 10/31/19). Also, the company's IVD licensing agreement with QIAGEN (see IBO 10/15/19) generated $30 million in sales, which exceeded the company’s expectations. Furthermore, sequencing systems and consumables revenues were in line with Illumina’s sales forecast.

Illumina by Product Line Q3 FY19

Rev. Chg. Sequencing Rev. Chg. Microarrays

Consumables 11.2% -9.6%

Instrument 2.9% -76.5%

Service & Other 26.6% -32.4%

Source: Science and Medicine Group

Sales of sequencing consumables grew 11.2% to $525 million, making it the first time the portfolio exceeded the $500 million mark. The company also noted that sales would have grown 13% excluding a $6 million tariff-related stocking order that shipped to China in the third quarter of 2018. Shipments of high-throughput sequencing consumables generated $300 million in sales, driven by a $200 million revenue contribution from NovaSeq consumables. Other NovaSeq highlights included sales growth of more than 20% sequentially. Sales of mid-throughput NextSeq consumables rose 20% thanks to a spike in sales for the NextSeq Dx, resulting in a 10 percentage point increase. Library prep sales grew 13% as a result of strong demand for the Nextera Flex Solutions and the TruSight Oncology 500 kit. Library prep sales have consistently accounted for at least 15% of sequencing consumables revenue.

Sequencing system sales grew 2.9% to $142 million and 10% sequentially, driven by both the high-throughput NovaSeq and mid-throughput NextSeq, as each experienced the second highest shipment of orders on a quarterly basis. The high volume of orders of NovaSeq systems was attributed to 35% of HiSeq customers transitioning to the newer system. In total, about one-third of

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HiSeq customers have transitioned to NovaSeq. Regarding low-throughput system orders, shipments of MiSeq, MiniSeq and iSeq systems grew sequentially due to strong demand in EMEA.

Sequencing service and other sales were up 26.6% to $138 million and 35% sequentially, driven by warranty and field services sales, and the IVD licensing agreement with QIAGEN (see IBO 10/15/19), which generated $30 million in sales. Another sales highlight included oncology development service sales, which rose sequentially and year over year. Growth of sequencing service and other sales were partially offset by declining sales to Genomics England’s 100,000 Genomes project.

Illumina Operating Margin Q3 FY19

Adj. Op. Profit (M) Chg. Adj. Op. Margin Chg. (bps)

$308 27.8% 34.0% 570.49

Source: Science and Medicine Group

Illumina's total microarray revenue declined 24% to $102 million as a result of falling sales of the direct-to-consumer (DTC) portfolio as well as broad-based declining demand across for instruments, consumables, and service and other sales. Specifically, falling sales of the DTC portfolio caused a 9.6% sales decline in microarray consumables revenue as well as a 32.4% sales decline in microarray service and other sales. Sales for microarray systems fell 76.5% to generate $4 million, an outcome anticipated by Illumina.

Illumina by Region Q3 FY19

Rev. (M) Chg. % of Rev.

US $514 8.4% 57%

EMEA $235 7.3% 26%

Greater China $95 -6.9% 10%

Asia Pacific $63 8.6% 7%

Source: Science and Medicine Group

Geographically, the Americas, EMEA and Asia Pacific each recorded high single-digit sales growth, while Greater China sales declined in the high single digits. America's revenue growth was driven by the oncology clinical research sector, which offset a $30 million sales headwind in the microarray business. EMEA growth was led by various large-scale initiatives, especially the sequencing initiative of the UK Biobank (see IBO 10/31/19). Asia Pacific sales were driven by the clinical and research sectors in Japan. Emerging markets' growing revenue was the result of strong demand for NovaSeq systems utilized for clinical and research purposes.

Greater China's sales declined in the high single digits. However, if accounting for the $6 million tariff-related stocking order that shipped in the third quarter 2018, the region's sales declined 1%. Sales highlights in China included strong demand for consumables from the reproductive health and oncology testing research sectors, as well as robust sales for NIPT and genetic disease testing. In contrast, demand from the research sector declined due to research funding in China reportedly falling 10% as a result of macroeconomic events in the region.

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Illumina forecast fourth quarter revenues to grow 8%, driven by an expectation that sequencing consumables sales will rise in the high teens. For its full-year revenues, the company continues to maintain a 6% revenue growth forecast, with the expectation that sequencing business sales will rise 10%. The company affirmed its outlook that NovaSeq instruments' full-year sales will be flat or slightly up, but revised its microarray business sales forecast to a 15% sales decline compared to the prior guidance of a 14% sales decline. Product wise, the company changed its full-year sales growth expectations for sequencing consumables from the mid-teens to the low teens, citing slow consumables sales related to non-high-throughput instruments.

Sluggish Sales for PerkinElmer’s Applied Market and Diagnostic

Business Does Not Deter Company’s Positive Outlook for the Year

PerkinElmer by Division Q3 FY19

Rev. (M) Chg. Currency Acq./ Div. Org. Growth % of Rev.

Total Company $706.9 4.8% -2% 2% 5%

Discovery & Analytical Solutions $426.9 5.1% -2% 3% 4% 60%

Diagnostics $280.0 4.4% -2% 0% 6% 40%

Source: Science and Medicine Group

PerkinElmer Diagnostics’ third quarter sales grew high single digits organically (see IBO 10/31/19), while Discovery & Analytical Solutions (DAS) sales increased low single digits organically. Total Product and Service revenues rose 3.9% and 6.9% to make up 70% and 30% of sales, respectively.

PerkinElmer's third quarter organic sales growth was 100 basis points below the company's forecast due to sluggish sales in the applied markets and delayed revenue in the Diagnostics business. However, PerkinElmer believed this does not impact the company's annual pattern of delivering high single-digit revenue growth. Geographically, Asia Pacific and Europe revenue growth was up mid-single digits, while the Americas reported low single-digit growth.

PerkinElmer Operating Margin by Division Q3 FY19

Adj. Op. Profit (M) Chg. Adj. Op. Margin Chg. (bps)

Total Company $78.7 -1.9% 11.1% -77

Discovery & Analytical Solutions $52.3 8.2% 12.3% 59

Diagnostics $47.4 0.1% 16.9% -74

Source: Science and Medicine Group

High single-digit sales in pharmaceutical and biotech markets led DAS sales, attributed to consistent sales in the life science business as well as double-digit sales growth from the informatics, imaging and detection product lines. In contrast, applied markets sales were flat as a result of tepid sales in

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China and Europe, which declined in the mid-single digits and low single-digits, respectively. Within applied markets, food revenue was up low single digits thanks to consistent demand in the cannabis business. DAS' industrial and environmental sales were flat, but experienced an uptick in sales sequentially. However, PerkinElmer noted that there have been no significant trend changes in the applied markets.

PerkinElmer by End-Market Q3 FY19

End-market Discovery & Analytical Solutions Diagnostics Chg.

Diagnostics — $280.0 4.4%

Life Sciences $243.2 — 9.4%

Applied Markets $183.7 — -0.1%

Source: Science and Medicine Group

In the Diagnostics division, low double-digit organic sales growth in the EUROIMMUN and Tulip businesses contributed to immunodiagnostics business revenue. EUROIMMUN experienced broad-based demand across its portfolio, especially for its autoimmune, allergy and infectious disease product lines, which all delivered double-digit sales growth. Geographically, EUROIMMUN continues to see strong demand in China and the US, with both regions reporting sales growth in the double digits. Reproductive sales grew mid-single digits organically, driven by genomics testing as well as an increased presence in the Asia-Pacific region. Applied genomics sales were moderate resulting from a tough comparison as a delayed order for automated workstations was completed in the third quarter of 2018.

PerkinElmer by Region Q3 FY19

Discovery & Analytical Solutions

Diagnostics

Rev. (M) Chg. % of Sales Rev. (M) Chg. % of Sales

Americas $178 5.4% 41.8% $97 1.2% 34.6%

Europe $120 8.2% 28.1% $70 2.5% 25.1%

Asia $129 2.0% 30.1% $113 8.6% 40.4%

Source: Science and Medicine Group

PerkinElmer revised its full-year revenue growth forecast to 5% organically versus the previous 5%–6% estimate. The new forecast of $2.88 billion includes $68 million from currency headwinds and a revenue contribution of approximately $41 million from acquisitions and divestitures. The company forecast fourth quarter revenues to grow 5% organically to $800 million, including an $11 million currency headwind.

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Third Quarter Results: Bruker, Danaher, Illumina, PerkinElmer, Thermo Fisher Scientific and Waters

Thermo Fisher Revenues Solid despite Divestment of Its Anatomical

Pathology Business

Reported high single-digit third quarter revenue growth for Thermo Fisher Scientific included a 1% increase from acquisitions, a 1% decrease from currency and a 1% decrease due to the divestiture of its Anatomical Pathology business (see IBO 1/31/19). The divestiture of the Anatomical Pathology business engendered a $55 million reduction in Thermo Scientific’s third quarter revenues. The company’s 7% organic growth encompassed a $90 million contribution that exceeded Thermo Fisher’s third quarter forecast.

Thermo Fisher Scientific by Division Q3 FY19

Rev. (M) Chg. % Organic Chg. % of Total Rev.

Total Company $6,272 5.9% 7%

Life Sciences Solutions $1,701 13.1% 13% 26%

Analytical Instruments $1,358 1.9% 3% 21%

Specialty Diagnostics $879 -1.7% 7% 13%

Laboratory Products & Services $2,619 6.0% 6% 40%

Source: Science and Medicine Group

Bioproduction and biosciences sales led revenue growth in the Life Sciences Solutions segment. Specifically, bioproduction sales were driven by demand for cell culture media and single-use products. The chromatography and MS product lines were the revenue drivers for Analytical Instruments. Specialty Diagnostics sales were impacted by the Anatomical Pathology sale, but the business segment still experienced revenue growth led by the transplant diagnostics and immunodiagnostics businesses. Laboratory Products and Services experienced broad-based sales growth, which was driven by pharmaceutical services.

Thermo Fisher Scientific by Region Q3 FY19

Rev (M) Chg. % of Total Rev.

North America $3,220 6.3% 51%

Europe $1,514 4.1% 24%

Asia-Pacific $1,349 7.8% 22%

Other $189 2.2% 3%

Source: Science and Medicine Group

Thermo Fisher’s total sales to the biotech and pharmaceutical end-market delivered double-digit growth as a result of strong demand across all business segments. Mid-single-digit revenue growth for the academic and government end-market was attributed to broad-based demand across all regions. Diagnostics and healthcare end-market revenue grew in the high single digits as a result of

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Third Quarter Results: Bruker, Danaher, Illumina, PerkinElmer, Thermo Fisher Scientific and Waters

transplant diagnostics and immunodiagnostics sales. Lastly, industrial and applied end-market revenue was flat with a tough year-over-year comparison related to strong sales of the electron microscopy and chemical analysis product lines in the second half of 2018. This was offset by healthy demand for chromatography and MS products.

Thermo Fisher Scientific by Product Line Q3 FY19

Rev (M) Chg. % of Total Rev.

Consumables $3,228 5.6% 51%

Instruments $1,570 3.6% 25%

Services $1,474 9.3% 24%

Source: Science and Medicine Group

North America and Asia-Pacific led regional growth, each with sales up in high single-digits. Within Asia-Pacific, Chinese sales rose 10.3% to $694 million, mainly as a result of demand from the industrial and biopharm end-markets. Within North America, US sales grew 6.1% to $3.1 billion. Europe’s mid-single digit sales growth was credited to Thermo Fisher’s presence in the region’s pharmaceutical and diagnostics end-markets.

Thermo Fisher Scientific Operating Margin by Division Q3 FY19

Adj. Op. Profit (M) Chg. Adj. Op. Margin Chg. (bps)

Total Company $1,423 8.5% 22.7% 54

Life Sciences Solutions $586 18.4% 34.5% 154

Analytical Instruments $311 5.8% 22.9% 85

Specialty Diagnostics $223 0.0% 25.4% 43

Laboratory Products & Services $303 1.3% 11.6% -54

Source: Science and Medicine Group

Thermo Fisher raised its 2019 revenue guidance to $25.34–$25.5 billion, which would represent 4%–5% growth. Specifically, the company raised its revenue guidance by $20 million and narrowed the range by $40 million. The company’s reasoning was a $19 million increase in its organic sales outlook due to a strong operational performance in the third quarter, resulting in an expectation of 6% organic growth for the year.

In addition, Thermo Fisher factored in a $90 million headwind from currency that occurred in the third quarter, exceeding its prior guidance, that caused it to forecast a 2%, or $500 million, headwind from currency for the full year. Lastly, the company expects its acquisition of the Cork, Ireland, API facility (see IBO 7/31/19) to contribute $20 million in sales for 2019. Fourth quarter sales are expected to increase in-line with the company’s full-year average.

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Third Quarter Results: Bruker, Danaher, Illumina, PerkinElmer, Thermo Fisher Scientific and Waters

Unexpected Sales Decline from US Pharmaceutical Customers Impact

Waters’ Quarterly Sales

Waters by Division Q3 FY19

Rev. (M) Chg. Constant Curr. Chg. % of Rev.

Total $577.3 -0.1% 1%

Waters Div. $512.1 -0.7% 0% 89%

Instrument Systems $223.9 -6.3% 39%

Chemistry $100.3 4.5% 17%

Service $188.0 4.0% 33%

TA $65.1 4.7% 5% 11%

Instrument Systems $46.5 6.7% 8%

Service $18.7 0.0% 3%

Source: Science and Medicine Group

Waters’ third quarter revenues grew 1.0% in constant currency, including a 1% currency headwind. Constant currency sales for the Waters Division were flat, while TA instruments sales jumped 5.0% (see IBO 10/31/19). All figures below are in constant currency.

Both service and chemistry sales led growth, up 5.0% and 6.0%, respectively, followed by instrument sales, which fell 3.0%. Third quarter financial results were in-line with the company's expectations, except for sluggish sales in the US due to key pharmaceutical customers. This was a surprise to Waters, as the first half delivered strong sales in the US pharmaceutical end-market. The company attributed the change to macroeconomic trends, Chinese government policies and political uncertainty in Europe.

Waters Operating Margin Q3 FY19

Adj. Op. Profit (M) Chg. Adj. Op. Margin Chg. (bps)

$173.3 1.0% 30.0% 32

Source: Science and Medicine Group

Sales of Waters-branded products and services were flat, as the combined sales of LC and LC/MS instruments declined 5%. Specifically, while LC instrument sales only declined slightly, LC/MS instrument sales were impacted by weak sales in the Chinese food market. Waters’ LC/MS instruments, especially tandem quadrupole LC/MS, experienced declining sales as a result of Chinese government policies. Despite this, the tandem quad LC/MS instruments portfolio saw demand from the biopharma R&D market.

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Third Quarter Results: Bruker, Danaher, Illumina, PerkinElmer, Thermo Fisher Scientific and Waters

Other Waters division sales highlights included the pharmaceutical end-market’s chemistry sales, which partially offset sluggish sales in the industrial, academic and government end-markets. The Waters division delivered strong sales of its application kits, UPLC columns and bioseparation columns product lines. Lastly, Waters-branded precision chemistry product and services’ recurring revenue rose 5% but recurring revenue for instrument sales declined 3%.

TA-branded products and services revenues grew 5.0%, with instrument sales rising 7% thanks to the strong sales of the thermal and microcalorimetry product lines.

Waters by Product Line Q3 FY19

Rev. (M) Chg. Constant Curr. Chg. % of Rev.

Instruments $270.3 -4.3% -3% 47%

Service $206.7 3.6% 5% 36%

Chemistry $100.3 4.5% 6% 17%

Source: Science and Medicine Group

In terms of Waters' end-markets, industrial sales were flat with strong sales in materials science offsetting weak global sales in the food testing market. Geographically, the industrial sales were robust in the US, but tepid in Europe. So far, the revenue growth for the industrial end-market has declined 2% year to date.

Academic and government sales fell in the low single digits, with strong sales growth for biomedical research in Europe offsetting weak sales in the Americas and China, especially the Chinese food market.

Geographically, pharmaceutical sales were strong in China and India, which offset slower sales in the US and Europe. Product wise, the small molecule application portfolio delivered modest sales, while the global sales for the large molecule business were robust.

Waters by End-Market Q3 FY19

Rev. (M) Chg. Constant Curr. Chg. % of Rev.

Pharmaceutical $328.2 0.9% 3% 57%

Industrial $171.4 -0.4% 0% 30%

Govt. & Academic $77.7 -3.9% -3% 13%

Source: Science and Medicine Group

On a geographical basis, Asia reported strong regional sales growth, with Japan delivering high single-digit sales growth and the combined sales of Asia Other experiencing double-digit growth. Despite accounting for 19% of Waters’ total sales and 47% of its Asian sales, China's revenue growth only rose in the low single digits. However, due to the 4+7 program rollout, Waters’ pharmaceutical end-market delivered double-digit growth in the region, offsetting a double-digit sales decline in the academic and government end-market. However, slow academic and government sales were impacted by weak food testing demand.

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Market Profile: Electron Spin Resonance/Electron Paramagnetic Resonance (ESR/EPR)

India's stable sales were driven by consistent demand in the pharmaceutical market, offsetting soft sales in the industrial market.

As stated before, within the Americas, US demand declined due to slower purchase decision for Waters’ key pharmaceutical customers affecting LC and LC/MS instrument revenues. In contrast, US industrial sales rose 5%. Also, the political events in Latin America, especially Brazil and Mexico, contributed to the Americas' overall high single-digit sales decline.

European sales were ultimately flat because of Eastern Europe's sales uptick was offset by a slight sales decline in Western Europe. Other European sales highlights included a 1% sales growth in the pharmaceutical end-market as well as double-digit growth in the academic and government end-market. Overall, total European sales were impacted by large pharmaceutical customers spending less on capital equipment as well as slow demand in the food and environmental markets.

Waters by Region Q3 FY19

Rev. (M) Chg. Constant Curr. Chg. % of Rev.

Asia $237.8 7.0% 7% 41%

China $111.7 1.8%

Japan $46.8 7.6%

Asia Other $79.3 15.0%

Americas $196.5 -5.0% -5% 34%

United States $164.2 -3.9%

Americas Other $32.3 -10.4%

Europe $143.0 -4.0% 0% 25%

Source: Science and Medicine Group

Due to the unexpected sales decline in the US pharmaceutical market as well as the overall uncertainty of the global economy, Waters forecast its fourth quarter organic sales to increase 0%–2%, with currency subtracting 1% growth. Despite the various economic headwinds that occurred in the third quarter, the company expects sales improvements in the US, varied market conditions in China and Europe, and significant revenue contributions from upcoming product launches. With the assumption that it reaches its fourth quarter forecast, the company revised its annual sales guidance to 1% growth, down from 1%–3%, with currency subtracting 1%–2% growth.

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Market Profile: Electron Spin Resonance/Electron Paramagnetic Resonance (ESR/EPR)

Market Profile: Electron Spin

Resonance/Electron Paramagnetic Resonance

(ESR/EPR)

Electron spin resonance (ESR), also sometimes referred to as electron paramagnetic resonance (EPR), is a molecular spectroscopy technique that studies the electron structure within a sample. The basic principle of ESR is similar to NMR. While both techniques look at a quantum property known as spin, they look at different subatomic particles. Where NMR looks at the spin of atomic nuclei, ESR is concerned with the spin of unpaired electrons. Both utilize strong magnets to generate a magnetic field, but differences in the techniques can be found in the energy used. NMR uses low-energy MHz waves, whereas ESR uses higher-energy GHz waves. Additionally, NMR instruments are typically much more expensive compared to ESR.

ESR instruments can be used to analyze samples in solids, liquids, gas or in vivo. A sample is first placed within a strong magnetic field, which causes the electrons in the sample to align parallel with the field. The sample is then exposed to a high-frequency energy in the form of microwaves, which is absorbed by the unpaired electrons. The energy absorbed corresponds to a difference in energy levels of the electron and causes them to align antiparallel with the magnetic field. This absorption of energy by the electrons can be detected and used to analyze the nature of the unpaired electrons. This is important because unpaired electrons in the form of free radicals can alter chemical reactions, degrade and oxidize products, or even cause damage to cells.

ESR is used in a variety of different industries, as it is the only technique that can nondestructively study unpaired electrons. In the agriculture and food industry, ESR is used to study the oxidative breakdown of food products. Pharmaceutical and life science labs utilize the instrument to study chemical reactions, especially the reaction mechanisms of enzymes and membrane proteins. ESR can also study the oxidative stress on cells. The electron state of materials can be studied as well, which is important to the materials science and semiconductor industries.

Like the rest of the NMR market, the ESR market is dominated by Bruker and JEOL. Bruker is the largest vendor and has recently consolidated its top position with the acquisition of Magnettech’s EPR business (see IBO 10/15/19). Bruker offers research-grade instruments like the ELEXSYS, and smaller benchtop instruments like the microESR. JEOL is the next largest vendor, and is more focused on larger, high-sensitivity instruments like the JES-X330. ADANI is the largest remaining vendor, offering the SPINSCAN X EPR spectrometer.

The total market for ESR in 2018 was less than $30 million. With little innovation in the technology, growth is expected be slow in the near future. While there has been a gradual transition to more accessible benchtop-size instruments in recent years, this is not expected to change the course of the market significantly. The relatively narrow use-case and long shelf life of these instruments will also keep demand at modest levels.

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Industry Watch

Leading Vendors

Bruker JEOL ADANI

Largest Markets

Pharmaceutical and Biotech Agriculture and Food Semiconductors

Instrument Cost

$20,000–$1 million

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Industry Watch

Industry Watch

Government

According to a proposed decision by the Centers of Medicare and Medicaid Services (CMA), NGS coverage can be expanded to cover as a diagnostic test when a patient: has ovarian or breast cancer; clinical indications for germline (inherited) testing; risk factors for germline (inherited) breast or ovarian cancer; and has not been previously tested using NGS. In addition, the diagnostic lab performing the NGS test must be cleared or approved by the US FDA; obtain an FDA approved or cleared indication for use in that cancer; and provide results to the treating physician to manage the patient using a specified report template that outlines treatment options. The diagnostic lab test must be performed in a CLIA-certified lab and ordered by a treating physician.

CMS released its first policy on NGS national coverage in March 2018. Certain NGS testing is currently covered by the CMA due to evidence indicating that it can effectively provide comprehensive data on multiple genomic alterations simultaneously, as well as offer a more detailed profile of genetic cancers. The tests must include the collection, processing and storage of specimens; DNA extraction; DNA processing and library preparation; sequence reads and base calling generation; sequence alignment/mapping; variant calling; variant annotation and filtering; variant evaluation and assertion; and, finally, the generation of the test report.

On October 29, the CMA posted the proposed decision and is accepting comments for a 30 day period.

Source: Centers for Medicare and Medicaid Services

Energy

Energy emissions reached a record high in 2018, according to the International Energy Agency’s (IEA) “World Energy Report 2019.” The report points to the widening gap between transitioning to renewables and the global reliance on fossil fuels, which is further growing due to geopolitical tensions and instability. According to the IEA, nearly one-fifth of the increase in global energy usage in 2018 was due to global warming, such as hotter summers pushing cooling energy demand and cold snaps that led to greater heating energy needs.

The Report indicates that if no changes are made to global energy policies, energy demand will rise 1.3% each year to 2040, which will greatly increase energy emissions and strain energy security. In another scenario, based on countries’ policies intentions and targets, energy demand is forecast to rise 1% yearly to 2040, with low-carbon sources, namely solar photovoltaics, contributing to over 50% of growth in demand and natural gas contributing 33%.

According to these scenarios, the US will account for over 80% of the increase in global oil production due to its shale output and 30% of the increase in gas production. US shale production is

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Region Watch

anticipated to exceed Russia’s total oil and gas production by 2025. However, the Report also points out that global growth in oil demand will begin to slow after 2025 and plateau in the 2030s, largely due to lower battery costs that will boost electric car demand.

The IEA proposes a more sustainable scenario, one that is aligned with the Paris Agreement, where significant emission cuts are made worldwide due to multiple fuels and technologies enabling cost effective services for the public.

Source: International Energy Agency

Forensics

Over the last year, judges in various states have thrown out evidence from 30,000 breath tests due to human errors and a lack of sufficient government oversight. Thousands of cases across the US have also been invalidated over the past few years. The scientific instruments that are used for breath tests have, in many instances, not been calibrated correctly, and, at times, reported results that were 40% higher than they should have been. Experts have reported cases of severe programming mistakes in breath test machines’ software, while certain states have used devices without ensuring the accuracy of the tests. Because of these errors, people have been wrongfully convicted, with hundreds of people unaware that their sentences were based on unreliable test results.

Many handheld breath test machines include fuel cells that react to alcohol in exhaled breath. The fuel cells generate an electric current, and the greater the current, the greater the alcohol level. However, things like mouthwash, breath mints and eructation can skew test results.

In most states, the limit for illegal drunkenness is 0.08 g of alcohol per 100 mL of blood. However, since drawing blood requires a warrant, law enforcement commonly depends on breath tests. But many machines have been tested by experts, with most showing inaccurate results, sometimes on nearly every single test. As more judges in states begin to disallow breath machine test results as evidence due to their inaccuracies, innocent people may be better able to plead their case.

Source: The New York Times

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Region Watch

Region Watch

South Africa

While R&D expenditures in South Africa are continuing to rise, growth has slowed, with gross expenditure on R&D (GERD) reaching ZAR 38.7 billion ($2.6 billion) in 2017–18, an 8.5% increase (3.1% in constant currency). This marks the seventh consecutive year that R&D expenditures have increased in South Africa, but the latest data points to a possible plateau of growth, particularly when compared to the R&D expenditure peak of 8.3% growth reported in 2014–15. GERD is defined as “an aggregated measure of in-house R&D expenditure performed domestically in five sectors, namely government, science councils, higher education institutions, the business sector, and the not-for-profit sector.”

In 2017–18, the government continued its streak of contributing the highest percentage of GERD, a trend that began in 2007–08, representing 47% of total expenditures. The business sector contributed 42% of GERD, while foreign and domestic sources accounted for 10% and 2%, respectively.

The business sector remains South Africa’s top R&D performer, accounting for 41% of total R&D activities conducted in 2017–18, while the higher education sector contributed 37%.

Source: South African Department of Science and Technology

China

When it comes to the biopharmaceutical sector, life science companies in China are focusing on developing innovations for the later stages of drug discovery. The Made in China 2025 initiative singled out nine key sectors for innovation, including biotechnology, which will receive significant funding. In its most recent Biotechnology Development Plan, the Chinese government called for the development of 20–30 new biotechnologies and 30–50 “major strategic new products.” With goals of mass innovation and entrepreneurship, the government has funded biotech startups and also encouraged private investors to do so through financial incentives.

Last year, biotech companies in China raised $2.9 billion in venture capital funding, which is double the funding raised in 2017, and also exceeds the amount raised by European biotech companies. The top venture financings in China focus mostly on companies developing antibodies against autoimmune diseases or cancer, as well as infectious diseases, genomics, biosimilars for cancers, and digital health and AI. On average, Chinese life science funds in 2018 totaled $764 million. Last year was also active in terms of M&A, with 218 such transactions with an average value of $209 million, a record for China.

The majority of Chinese biopharma companies focus on generics, but there is a growing biosimilar sector. Many of these firms are also working on innovating new drugs, while a smaller number of

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News

companies are developing new molecules against novel targets or new experimental therapeutic molecules.

However, the rapid rise of Chinese biopharma has not addressed a key need for improvement, bridging the divide between academia and industry. China’s Biotechnology Development Plan did not include the establishment of new biotech transfer and transformation centers, resulting in a low level of technology transfers.

Source: Nature Biotechnology

Hungary

In 2018, R&D spending in Hungary jumped 27.0% to HUF 654 billion ($2.2 billion), representing 1.53% of the country’s GDP.

Business R&D spending accounted for 52% of total expenditures, dropping four basis points, but rose 25.7% to reach HUF 342 billion ($1.1 billion). Government spending represented 32% of total R&D expenditures, rising almost one percentage point, with a 28.3% spike in growth to HUF 211 billion ($696.6 million).

Funding from foreign resources also grew significantly in 2018, jumping 25.9% to HUF 97 billion ($320.2 million) to account for 15% of total expenditures, the same share as in 2017. Approximately 79% of foreign funding for R&D came from corporations. Additionally, HUF 17.5 billion ($57.7 million) in R&D funding came from EU grants.

Nearly HUF 113 billion ($373.1 million) funded various R&D projects. Of total expenditures, HUF 536 billion ($1.8 billion) was spent on general R&D costs, including HUF 303 billion ($1.0 billion) on personnel and staff, HUF 61 billion ($201.4 million) on materials and HUF 112 billion ($369.8 million) on purchasing services.

Source: Hungarian Central Statistical Office

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News

News

Broad-based Companies

Company Announcements

The California Employment Development Department September filing revealed that Illumina intends to lay off 16 employees at its Foster City site and 42 at its San Diego site in November.

Third quarter sales for Teledyne Technologies’ Environmental Instrumentation business grew 20% to $102.6 million, or 36% of total revenues, due to acquisitions. The company reported organic sales growth for process gas analyzers and certain laboratory instruments, but lower sales of pollution control equipment in Asia.

Third quarter sales for GE Healthcare Life Sciences jumped 14% on an organic basis, and orders rose 10% organically. The company forecasts mid-single-digit sales growth for its Biopharma business this year.

In the third quarter, AMETEK Process and Analytical Instrumentation sales grew 14.0% to $586.4 million, representing 72% of total sales. The company expects its acquisition of Gatan (see IBO 9/30/19), completed on October 31, to add $35 million in sales this year.

UK-listed Scientific Digital Imaging, which designs and manufactures scientific and technology products for digital imaging and sensing and control, changed its name in November to SDI.

In November, Thermo Fisher Scientific announced the opening of a Customer Solution Center (CSC) in Mumbai, India. Among the CSC’s focuses will be the development of next generation chromatography and MS workflow solutions.

In November, Thermo Fisher Scientific announced the opening of a Customer Solution Center in Shanghai, China. The new Pharma and BioPharma Center will support the rapid delivery of novel and high-quality therapeutics by providing expertise in critical analytical processes and specialized workflows.

CDMO and lab product supplier Lonza announced in November that CEO Marc Funk is leaving the company for personal reasons, effective January 2020. Board Chairman Albert Baehny will serve as interim CEO.

In November, Danaher named Jessica L Mega, MD, MPH, and Pardis C. Sabeti, MD, D.Phil, to its Board. Dr. Mega is currently chief medical and scientific officer of Verily Life Sciences, an Alphabet company. Dr. Sabeti is currently an investigator for Howard Hughes Medical Institute. She is also a professor at both the Center for Systems Biology and the Department of Organismic and Evolutionary Biology at Harvard University and the Department of Immunology and Infectious Disease at Harvard School of Public Health.

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Mettler-Toledo’s third quarter Lab revenues rose 7% in local currency, 5% in US dollars, to $388.4 million, or 52% of company revenues (see Bottom Line). The increase was led by China, where sales grew high single digits, and the Americas. The company anticipates Lab sales to grow mid-single digits in 2020.

Sales and Orders of Note

In November, CRO Sygnature Discovery added an in-house high-throughput screening platform for drug discovery. The system combines Titian Mosaic sample management technology with an automation platform from HiRes Biosolutions. Data analysis is facilitated using Genedata software. According to Sygnature, this is the first time these three vendors have worked together on the same system.

Sequencing

Company Announcement

In September, the Center for Forensic Science Research & Education (CFSRE) and Verogen entered into a collaborative agreement. CFSRE, supported through this collaboration, has recently completed the validation of Verogen’s ForenSeq DNA Signature Prep Kit on Verogen’s MiSeq FGx platform.

Genomenon partnered in September with rare disease advocacy group BPAN Warriors, with the goal of providing resources to assist researchers and encourage pharmaceutical companies to invest in finding efficacious treatments for Beta-Propeller Protein-Associated Neurodegeneration (BPAN), a progressive disease causing abnormal iron deposits in the brain. As a result, Genomenon used Mastermind to produce a curated database of the research related to 94 unique variants (genetic mutations) found within the gene linked to BPAN (WDR45), which will be freely available.

In September, Genomenon partnered with Congenica to incorporate its Mastermind Genomic Search Engine results into Congenica’s clinical decision support platform for genomic data interpretation. Mastermind has indexed nearly 7 million full text articles and 500,000 supplemental data sets and covers more than 4.9 million variants found in the medical literature.

Genomenon announced in October that a partnership with genomics data analysis provider SOPHiA GENETICS that includes incorporating the Mastermind Genomic Search Engine into the SOPHiA Platform and the Alamut Suite.

In October, Lexogen and BlueBee, global experts in transcriptome sequencing and bioinformatics, respectively, announced the implementation of the CORALL Total RNA-Seq data analysis pipeline on the BlueBee platform. Released by Lexogen earlier this year, CORALL is a novel all-in-one RNA-Seq Library Prep Kit. The CORALL data analysis pipeline on the cloud-based BlueBee platform provides CORALL users with an end-to-end solution.

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In October, BC Platforms, a genomic data management and analytics provider, today announced that it has formed a collaboration with genetic testing firm Blueprint Genetics to develop new data driven services for hospitals and the life sciences industry.

PierianDx, a clinical genomics informatics company, closed in October a $27 million Series B funding round led by ATW Partners and SJF Ventures that also includes existing investors Health Catalyst Capital, Inova Health Systems, RTI International and ARUP Laboratories.

Under a collaboration announced in October, NRGene’s cloud-based AI technology will be adopted into BASF soybean research–project evaluations to accelerate trait discovery and breeding across diverse crops.

In October, sequencer firm Shenzhen MGI Technology and AmCare Genomics Laboratory, a Chinese third-party clinical genetic testing service organization, signed a strategic cooperation agreement for single-gene genetic disease detection. AmCare Genomics Laboratory will develop a solution for genetic testing of single-gene genetic diseases based on MGI's high-throughput sequencing platform from sample to report interpretation.

NGS diagnostics firm Pillar Biosciences announced in October that under a comarketing agreement MGI will market its ONCO/Reveal NGS panels to its sequencer customers, highlighting the compatibility between Pillar's NGS assays and MGI's sample preparation platforms, which combine liquid handling capabilities with thermocycling in order to fully automate the entire library preparation process. Pillar Biosciences, which provides SLIMamp target enrichment chemistry, also announced that its Pillar ONCO/Reveal NGS panels are now compatible with Thermo Fisher Scientific’s Ion Torrent and MGI’s sequencing platforms.

In October, Genialis announced a partnership with Thermo Fisher Scientific connecting Thermo Fisher’s Collibri RNA sequencing kits with Genialis Expressions software.

Twist Bioscience, which offers high-quality synthetic DNA, and MGI, a subsidiary of global genomics firm BGI, entered into a comarketing agreement for Twist Bioscience’s target enrichment product line in Europe and Asia Pacific. The product line will be specifically formatted to work with MGI’s DNBSEQ sequencers and with the appropriate MGI-compatible products.

China Deal Monitor reported in November that single-cell sequencing firm Yikon Genomics raised $31 million in a series C round led by Guangzhou Kingmed, a medical lab company. Yikon Genomics’ MALBAC (Multiple Annealing and Looping Based Amplification Cycles) is designed for reproduction health, cancer diagnostics and life science research applications.

Pacific Biosciences’ third quarter revenues grew 20.7% to $21.9 million, with product revenue making up 84% of total sales (see Bottom Line). Instrument sales increased 84.0% to $11.6 million. Consumables revenue declined 22.1% to $6.9 million. The company reported cash, cash equivalents and investments, excluding restricted cash, of $49.2 million as of September 30.

In November, QIAGEN announced a cross-marketing and promotion agreement with Japan’s Repertoire Genesis to cover joint market education with the goal of accelerating the development and availability of companion diagnostic tests on Illumina NGS platforms using the TCR technology developed by Repertoire Genesis in the field of immune-oncology. QIAGEN also received licensing rights relating to an epigenomic immune checkpoint gene methylation test developed at the

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University of Bonn in Germany. QIAGEN intends to leverage this license to develop companion diagnostics for use in selecting patients likely to benefit from specific immuno-oncology therapies. QIAGEN also announced exclusive access to biomarker intellectual property from STRATIFYER Molecular Pathology, which is developing guidance for treatment decisions in bladder cancer and potentially also in other urothelial cancers.

In November, the Million Microbiome of Humans Project (MMHP) was officially launched. The project was jointly begun by the Karolinska Institute of Sweden; Shanghai National Clinical Research Center for Metabolic Diseases in China; the University of Copenhagen, Denmark; Technical University of Denmark; MetaGenoPolis at the National Institute for Agricultural Research (INRA), France; the Latvian Biomedical Research and Study Centre; and Shenzhen BGI Research. The project will rely on MGI's DNBSEQ microbial genome sequencing technology to draw human microbial maps of different populations and health conditions and establish a baseline of microecology research at the large-scale population level, in order to promote the research of cutting edge translational medicine in the field of human microbiome.

Armonica Technologies, a biotech company developing a nanochannel-based, long-read DNA sequencing technology, named Victor Esch, PhD, as president and CEO. He most recently served as CEO of DNA Electronics.

Precision oncology firm Lexent Bio entered into a partnership with Illumina in November to develop an IVD kit for its future portfolio of NGS-based cancer diagnostics. Currently under development, Lexent’s Confera Dx test is for monitoring therapeutic response in patients with certain solid tumor cancers and for monitoring minimal residual disease. Illumina will sell the NextSeq 550Dx System and associated consumables and service.

Product Introductions

In September, ChunLab, a provider of bioinformatics for bacterial taxonomy and the microbiome, unveiled the beta version of its TrueBac ID system, calling it the world’s first genome-based cloud solution for bacterial identification and noting that it targets over 12,000 species.

In October, Congenica, a digital health technology company enabling accelerated interpretation of complex genomic data to improve disease diagnosis, announced the integration of new reference data sources, DECIPHER and Congenica’s Mastermind, into its clinical decision support platform.

UK-based NGS product firm Nonacus introduced in October ExomeCG exome capture kit, a new product designed by Congenica to simplify the generation and interpretation of molecular and cytogenomic data. The kit enables whole exome sequencing and targeted copy number analysis in a single assay. The clinically validated test replaces the need for chromosomal microarray and multiplex ligation-dependent probe amplification (MLPA) front line tests.

Gencove, a low-pass genome sequencing technology provider, debuted what it called the first enterprise-ready low-pass sequencing analysis platform. The new cloud-based solution for imputation and downstream analytics of low-pass sequencing data supports human, agricultural,

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companion animal and model organism applications. Gencove's SaaS also provides additional analysis such as polygenic risk score calculations, ancestry/breed analysis and CNV analysis.

HTG Molecular Diagnostics introduced in October the new 2,002-gene HTG EdgeSeq Autoimmune Panel, which is commercially available as a kit or a service in HTG’s VERI/O laboratory. EdgeSeq technology automates complex, highly multiplexed molecular profiling from solid and liquid samples.

In October, New England Biolabs (NEB) introduced the NEBNext Direct Genotyping Solution, calling it the first capture-based approach for high-throughput genotyping for a wide variety of applications in agbio. It is applicable for marker ranges spanning 100–5,000 markers, pre-capture multiplexing of up to 96 samples, in addition to dual-indexed unique molecular identifier sequencing, allowing for more than 3.8 million genotypes in a single Illumina sequencing run.

New England Biolabs (NEB) announced in October an expansion of its RNA depletion product portfolio to support more sensitive and cost-effective RNA sequencing. The NEBNext RNase H-based RNA depletion protocol offers efficient and specific depletion of the abundant RNA species that interfere with the analysis of both coding and non-coding RNAs of biological significance. The new NEBNext Globin & rRNA Depletion Kit (Human/Mouse/Rat) and NEBNext rRNA Depletion Kit (Bacteria) complement the existing NEBNext rRNA Depletion Kit (Human/Mouse/Rat). All kits are available both with and without RNA Sample Purification Beads, and have a 2-hour workflow, requiring less than 10 minutes of hands-on time.

Genomics solutions provider Integrated DNA Technologies (IDT) debuted in October NGS Discovery Pools, high-quality, individually synthesized, 5’-biotinylated oligo pools designed to enable researchers to rapidly build custom panels at a fraction of the cost compared to conventional panels.

In October, MGI, a subsidiary of global genomics leader BGI, previewed early research results from its revolutionary CoolMPS sequencing technology. CoolMPS avoids DNA "scars" that can accumulate with traditional sequencing methods and affect the accuracy of subsequent reads. CoolMPS introduces unlabeled nucleotides and four fluorescent labeled antibodies in its sequencing process to recognize the incorporated bases. In this new process, the natural “scarless” bases are added in each sequencing cycle, enabling more accurate and longer reads. CoolMPS is available to selected early access partners or research collaborations for co-development and validation.

In October, bioinformatics firm SOPHiA GENETICS introduced a new version of SOPHiA Whole Exome Solution, featuring high resolution (2–5 exons) CNV detection in a single workflow without the need for any reference sample. It now includes Familial Variant Analysis (trio analysis) to automatically filter variants based on different inheritance modes.

SeraCare Life Sciences, part of the LGC Clinical Diagnostics Business Unit and a partner to global IVD manufacturers and clinical laboratories, released in October what it called the first-ever gDNA and FFPE reference materials for tumor mutational burden (TMB) measurement by NGS assays. SeraCare can also create custom tissue and blood-based TMB reference materials through its VariantFlex custom reference material development platform.

In November, Loop Genomics, a long-read sequencing company with a hardware-free solution, released a new long-read 16S sequencing service for studies with large cohorts. With this offering,

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labs running at least 200–1,000 samples will pay $38–$20 per sample depending on volume. This service provides a complete solution that includes library preparation, sequencing and data analysis.

Loop Genomics debuted in November a new sample prep kit and service for long-read sequencing of long PCR amplicons on Illumina sequencers. Researchers in any discipline with PCR fragments up to 3 Kb can utilize Loop Genomics’ long-read technology. Additionally, Loop’s service lab is currently processing orders for PCR fragments up to 6 Kb.

Paragon Genomics, a provider of amplicon-based target enrichment solutions, announced the upcoming introduction of the CleanPlex CFTR Panel for cystic fibrosis and CleanPlex Fusion Detection Methods for the diagnostic and prognostic assessment of cancer tumor progression.

In November, Genomenon released Mastermind version 2.0. The Genomic Search Engine now includes the ability to search the entirety of the genomic literature by phenotypes (symptoms). This new functionality will further accelerate diagnosis of patients with genetic and rare diseases.

In November, Thermo Fisher Scientific introduced its Oncomine Precision Assay, a pan-cancer panel for the Genexus platform (see AMP 2019 Highlights: Faster Cancer Detection, Improved Treatment Selection and More Efficient Workflows). It enables comprehensive genomic profiling from FFPE tissue and liquid biopsy samples with a single assay.

Sales and Orders of Note

In October, Discovery Life Sciences, a provider of biospecimen analysis, procurement, distribution and scientific services, announced a substantial investment in Pacific Biosciences’ long-read genomic sequencing technology. The instrumentation will complement the existing infrastructure of HudsonAlpha Discovery, Discovery's genomic sequencing and bioinformatics division.

In October, Illumina announced that Texas A&M AgriLife Genomics and Bioinformatics Service added its DRAGEN (Dynamic Read Analysis for GENomics) server to the Texas A&M AgriLife Sequencing Center. The Illumina DRAGEN Bio-IT Platform provides accurate, ultra-rapid secondary analysis of sequencing data. In its latest release, v3.4, the platform has improved accuracy and speed for RNA gene fusion detection and quantification, and added functionality and accuracy enhancements to small variant calling and structural variant calling.

MS & LC/MS

Company Announcements

In September, MOBILion Systems partnered with Agilent Technologies to integrate its ion mobility separations technology, called Structures for Lossless Ion Manipulation (SLIM), with Agilent’s Q-TOF MS platform as the company’s first commercial product offering. This is the first of several partnerships through which MOBILion will integrate its ion mobility capabilities with MS platforms. The SLIM technology can be integrated with LC/MS workflows to provide more robust analytical information, and for some applications, replace LC. A beta model will launch in 2020 with broader

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commercial availability planned for 2021. MOBILion has an exclusive license to SLIM technology, which was invented in the lab of Dr. Richard D. Smith at Pacific Northwest National Laboratory, for life science applications.

In October, MOBILion Systems, developer of the Structures for Lossless Ion Mobility (SLIM) technology, opened a new 10,000 ft2 (929 m2) facility in Chadds Ford, Pennsylvania, which includes expanded product development, applications development and customer demonstration laboratories that will foster industry collaboration.

In November, MOBILion Systems announced a partnership with Drs. Lance Wells and Michael Tiemeyer, principal investigators at the Complex Carbohydrate Research Center, University of Georgia, for evaluation of its patented ion mobility separations technology, called Structures for Lossless Ion Manipulation (SLIM), for the research of glycans and glycoproteins. The SLIM platform will address existing challenges in glycobiology and help researchers better understand the correlation between glycan structure and function.

MOBILion Systems announced in November that it raised $15.4 million in series A financing. The round was led by Agilent Technologies, with participation from IP Group, Hostplus, Cultivation Capital and iSelect Fund.

Thermo Fisher Scientific announced in September a collaboration with nonprofit academic healthcare organization Cedars-Sinai. The goal is to develop advanced LC/MS-based workflows for the untargeted screening and targeted quantitation of protein-based biomarkers for critical disease. Specific aims include: developing robust data acquisition strategies for global plasma protein profiling and peptide selective reaction monitoring (SRM) assays for the direct analysis of plasma with or without enrichment; optimizing quantitative intact protein analysis methods for plasma using Thermo Scientific Q Exactive Orbitrap MS technology; and assessing targeted protein workflows with Thermo Scientific’s new generation triple quadrupole MS systems for large quantitation assays within a CLIA environment.

In October, Thermo Fisher Scientific signed a memorandum of understanding with China-based diagnostics lab companies Milu Lab to collaborate on a solution for noninvasive risk stratification to predict adverse pregnancy. A general framework for cooperation supports the development of a clinical MS-based proteomics assay that brings together the NX Prenatal NeXosome platform and Thermo Fisher's analytical technology for the Chinese reproductive health segment.

Astrotech created a new subsidiary company, Agriculture Technology (AG-TECH), in September. Its MS technology, incorporated in the AG-LAB-1000 series, is designed for applications in agriculture. The product line includes systems for outdoor continuous fenceline air quality monitoring protection for airborne pesticides, as well as field, mobile and lab units for cannabis testing.

In September, analytical technologies firm SCIEX announced that a suite of its medical devices has been approved by ANVISA, the Brazilian Health Regulatory Agency, for meeting the market access requirements for medical device products. The devices include the SCIEX triple quad 4500MD LC-MS/MS, QTRAP 4500MD LC-MS/MS, Topaz and Citrine systems.

In September, SCIEX extended its partnership with Protein Metrics, a provider of MS software for protein characterization, to enable additional connectivity between the software suite and SCIEX

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high-resolution accurate mass systems. The new integrations with the SCIEX X500 Systems are now available as part of Protein Metrics’ Byos software. SCIEX and Protein Metrics began integration over four years ago with the TripleTOF 5600 and TripleTOF 6600 LC/MS/MS Systems.

The UK’s Teesside University’s National Horizons Center in Darlington opened in October the Waters Bioanalytical Laboratory. The Center is a £22.3 million ($27.3 million) national center of excellence for the UK bioscience industry. The laboratory is the result of a long-standing collaboration between Waters and Professor Jim Scrivens, a research professor in Teesside University’s School of Health & Life Sciences.

In its quarterly SEC filing, Bruker disclosed that Waters filed a complaint in September in District Court in Düsseldorf, Germany, alleging infringement by Bruker of a European patent pertaining to the timsTOF product line. Bruker stated it intends to vigorously defend against this claim.

Product Introductions

In September, research reagent supplier Atlas Antibodies released pre-quantified QPrEST Protein Standards for absolute quantification of proteins in biological samples such as cell lysate and plasma using LC/MS. QPrESTs are added to the sample early in the workflow, prior to proteolytic digestion. The shared amino acid sequence of the QPrEST and the endogenous protein enables the QPrEST to correct for variation introduced during sample digestion, thereby increasing accuracy in quantification.

Bruker launched in September the diaPASEF workflow, a novel data-independent acquisition (DIA) method on its timsTOF Pro platform. The timsTOF Pro leverages trapped ion mobility spectrometry (TIMS) and parallel accumulation-serial fragmentation (PASEF). The new diaPASEF workflow uses overlapping windows in the ion mobility domain to trigger MS/MS, efficiently using the quadrupole to transmit precursor ions at high sensitivity. Over 7,500 proteins were identified in a 120 minute single-shot experiment on 200 ng of HeLa digest.

In September, Biognosys added beta support for Bruker’s diaPASEF technology within its Spectronaut data-independent acquisition (DIA) proteomics software. With this update, Spectronaut supports the complete workflow from library generation of PASEF data to the targeted analysis of diaPASEF data.

Shimadzu released in October the Peakintelligence software for its triple quadrupole LC/MS/MS systems. The optional Peakintelligence software automatically detects peaks that appear frequently in the software window. The software replaces the conventional process of visual confirmation by the operator. Developed through collaborative research with Fujitsu, this product works with LC/MS/MS systems utilizing method packages for primary metabolites and cell culture profiling.

Thermo Fisher Scientific launched in November the Thermo Scientific Anionic Pesticides Explorer, a high-throughput, sample-to-result, IC-MS/MS-based analytical workflow comprised of the Thermo Scientific Dionex Integrion High Performance IC system coupled with the Thermo Scientific TSQ Altis Triple Quadrupole MS for the multi-residue detection, identification and quantification of anionic pesticides at low concentrations in complex food matrices.

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Sales and Orders of Note

In September, Dalhousie University announced that it will soon be home to Atlantic Canada’s only Thermo Fisher Scientific Orbitrap Fusion MS system at a cost of $1.3 million. The new equipment will be housed in the Dalhousie University Faculty of Medicine Mass Spectrometry and Proteomics Core Facility.

In November, Aston University and Waters announced the installation of the world’s first Waters Select Series Cyclic IMS (ion mobility spectrometry) MS system. The system is located at the University’s School of Health and Life Sciences, where it will support research into the biology of human diseases, the discovery of new therapeutics and advances in biotechnology.

Bioprocess Analysis

Company Announcements

In September, GE Healthcare and biotech firm Germfree announced a collaboration to develop a fully integrated, expandable manufacturing solution for emerging biotherapeutics, including gene therapy. The manufacturing solution will feature a Germfree modular bioprocessing environment based on GE Healthcare's proprietary design and equipped with FlexFactory, GE Healthcare's integrated single-use biomanufacturing platform. This will be the latest addition to GE Healthcare's KUBio prefabricated manufacturing facility offering.

GE Healthcare and Ireland’s National Institute of Bioprocessing Research and Training (NIBRT) announced in September that they are combining their expertise to deliver educational programming on biopharmaceutical and cell therapy development and manufacturing. As part of the collaboration, GE Healthcare and NIBRT will share programming, including GE Healthcare’s Fast Trak training and education curriculum as well as co-develop a new curriculum. The GEHC and NIBRT co-developed curriculum will include single-use applications training, cell therapy technology, process efficiency strategies, process development methodologies and chromatography proficiency.

In September, H.E.L., a manufacturer of laboratory tools for process optimization, safety and scale-up, named Louise Madden as CEO. She was formerly CEO of Applied Photophysics. The announcement follows the company having secured a £5.9 million ($7.3 million) investment from private equity firm Connection Capital.

Arranta Bio completed in October an $82 million funding round and a strategic partnership with Thermo Fisher Scientific. Arranta's goal is to be the best-in-class microbiome CDMO. The business provides live biopharmaceutical products for microbiome pioneers by bacterial fermentation, isolation, drying and encapsulation. In addition to Thermo Fisher, Arranta's funding round was completed with sole institutional investor, Ampersand Capital Partners, and company founders.

In November, Thermo Fisher Scientific announced an investment of nearly $24 million in its Inchinnan, Scotland, site to expand global bioproduction capabilities with additional large-volume liquid manufacturing capacity for cell culture media for the upstream and downstream bioprocessing workflow. The expansion is expected to be completed by June 2021.

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Product Introductions

Earlier this year, Univercells introduced the scale-X carbo bioreactor system for viral production, a benchscale automated cell culture system. A scalable, fixed-bed reactor, it is suited for rapid process development and clinical products. The fixed-bed structure provides a high surface area available for predictable cell culture in a very low footprint.

In September 3, BugLab, a manufacturer of optical sensors for bioprocess monitoring, debuted the miniBE, calling it the first noninvasive online sensor capable of accurately measuring cell biomass over the full range of process conditions typically encountered during microbial fermentations in small vessels and single-use fermenters. In addition to being offered as a stand-alone device, the miniBE sensor technology has also been pre-integrated into Sartorius Stedim Biotech's ambr 15 fermentation, ambr 250 modular and ambr 250 high-throughput single-use bioreactor systems for microbial applications.

In October, GE Healthcare Life Sciences introduced the KUBio box, a fully integrated, flexible and adaptable biomanufacturing environment to accelerate the production of viral vector-based gene therapies. KUBio box supports up to 200 L scale manufacturing adapted to GMP standards and is designed to fit into repurposed or retrofitted existing spaces, as well as new facilities. The new modular environment allows for future expansion at different production scales and product technologies.

Sales and Order of Note

In October, Ovizio Imaging Systems, which offers microscopic imaging technology to the bioprocessing market, executed a supply agreement with Celgene for the automation of certain engineered T-cell manufacturing processes. These agreements follow a technology development effort initiated in 2018.

Process Analysis

Company Announcements

In August, INCJ (Innovation Network Corporation of Japan) announced an $8 million follow-on investment in Atonarp. Atonarp has raised $33 million in series C funding. Atonarp’s analytical equipment is used to measure the properties and quantity of gases or liquids during research processes such as semiconductor and energy production management, and pharmaceutical and food QC.

Product Introductions

In October, Metrohm Process Analytics launched the 2060 Process Analyzer, an integrated solution for 24/7 online monitoring of chemical parameters in industrial processes and wastewater streams. The modular system enables custom configurations for monitoring single or multiple process

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streams. The Metrohm 2060 Process Analyzer offers modularity within 1 cabinet, and also contains up to 4 cabinets to create 1 single analyzer platform.

ABB released in October the AWT420 transmitter, a four-wire, dual-channel analytical transmitter that measures multiple parameters in a single device, optimizing process performance for efficient water usage and treatment. It is capable of measuring multiple parameters including pH/ORP, conductivity, dissolved oxygen and turbidity.

In November, HORIBA Scientific released the PoliSpectra M116 MultiTrack Fiber Spectrometer, a fiber-coupled multispectral system capable of simultaneous measurement of up to 32 channels. Features include a concentric optical design with UV extended spectral range (below 185 nm with optional N2 purge).

In November, AMETEK Process Instruments unveiled the StreamPro process MS. Applications for the include monitoring for any number of analytes (C1–C8, H2, N2, CO2, CO, O2, VOCs and other components m/z 1–200 amu) in a broad range of markets. Different calibration and analysis methods can be assigned to each sample port.

Sales and Orders of Note

Earlier this year, Orbital Gas Systems, a CUI Global subsidiary, received orders for its GasPTi-F natural gas analyzer from SAMSON, its global distribution partner, for utilization by a large industrial user of natural gas in Spain.

In September, Orbital Gas Systems announced the receipt of orders to supply its GasPTi systems for deployment across multiple natural gas plants by one of the largest US-based producers and transporters of energy.

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Bottom Line

Reported Financial Results

$ in Millions USD Period

Ending

Sales Chg. Op. Prof.

Chg. Net Prof.

Chg.

10x Genomics Q3 30-Sep

$61.21 67.2% -$9.91 33.7% -$9.60 37.4%

Bionano Genomics Q3 30-Sep

$3.31 17.1% -$5.69 4.7% -$6.40 -29.9%

Bio-Rad Laboratories Q3 30-Sep

$560.63 2.8% $57.46 58.4% -$258.82

NM

Bio-Rad Laboratories (Life Sciences)

Q3 30-Sep

$215.70 4.4% $11.60 13.7% NA NA

Brooks Automation* Q4 30-Sep

$200.23 25.4% $11.11 207.2% $412.66 3886.7%

Brooks Automation (Life Sciences)*

Q4 30-Sep

$94.00 84.3% $40.07 108.9% NA NA

Brooks Automation* FYE 30-Sep

$781.87 23.8% $46.54 48.2% $437.75 275.5%

Brooks Automation (Life Sciences)*

FYE 30-Sep

$334.00 69.5% $141.71 89.6% NA NA

Bruker Q3 30-Sep

$521.10 11.7% $87.80 27.1% $61.30 41.2%

Bruker (Sci. Instr.) Q3 30-Sep

$471.80 13.1% $84.00 32.1% NA NA

Bruker (Energy & Supercon.) Q3 30-Sep

$52.50 3.1% $3.70 -31.5% NA NA

Danaher Q3 30-Sep

$5,037.30 3.8% $834.80 0.5% $673.90 1.5%

Danaher (Life Sciences) Q3 30-Sep

$1,695.60 6.2% $342.50 9.5% NA NA

Danaher (Environmental & Applied Solutions)

Q3 30-Sep

$1,080.50 0.6% $256.50 0.9% NA NA

Fluidigm Q3 30-Sep

$26.50 -8.5% -$13.82 -18.8% -$12.89 12.6%

HTG Diagnostics Q3 30-Sep

$5.40 14.8% -$4.62 3.8% -$4.74 2.1%

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IDEX (Health & Sci Tech.) Q3 30-Sep

$229.61 3.2% $40.17 -18.3% NA NA

Luminex Q3 30-Sep

$78.7 8.6% -$5.7 NM -$5.3 NM

Meridian Biosciences* Q4 30-Sep

$50.8 -4.2% $5.8 -17.7% $4.1 -24.5%

Meridian Biosciences (Life Sciences)*

Q4 30-Sep

$17.4 7.1% $5.8 66.5% NA NA

Meridian Biosciences* FYE 30-Sep

$201.0 -5.9% $32.7 3.5% $24.4 2.2%

Meridian Biosciences (Life Sciences)*

FYE 30-Sep

$64.3 1.9% $20.6 49.1% NA NA

Mettler-Toledo Q3 30-Sep

$753.9 2.6% $196.2 7.8% $129.40 2.2%

NanoString Technologies Q3 30-Sep

$30.60 $0.07 -$20.71 -$0.37 -$22.75 -38.0%

Pacific Biosciences Q3 30-Sep

$21.92 $0.21 -$28.11 -$0.14 -$29.12 -16.3%

Quanterix Q3 30-Sep

$14.9 41.1% -$10.2 -33.7% -$9.9 -28.9%

Repligen Q3 30-Sep

$69.4 40.2% $8.0 1.0% $1.7 -65.4%

Xylem (Water Infrastructure) Q3 30-Sep

$531.0 -1.8% $97.0 -2.0% NA NA

Other Currencies (in Millions)

Biotage Q3 30-Sep

SEK 282.70

21.7% SEK 64.33

42.5% SEK 73.12

68.9%

DKK-TOA** Q2 30-Sep

¥7,482.00 -12.1%

¥601.00 -30.8% ¥398.00 -30.4%

HORIBA Q3 30-Sep

¥45.42 -1.4% ¥3.72 -2.5% ¥2.66 -10.6%

HORIBA (Scientific Instruments)

Q3 30-Sep

¥6.1 -12.5%

-¥0.2 NM NA NA

HORIBA (Process & Environmental)

Q3 30-Sep

¥4.7 10.8% ¥0.3 -0.6% NA NA

Skyray Q3 30-Sep

¥204.94 -10.9%

¥4.02 -87.0% -¥9.08 NM

Notes: *For fiscal year ending Sept 30, 2019**For fiscal year ending March 31, 2020

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NA = Not AvailableNM = Not Material

Source: Science and Medicine Group