The world leader in serving science
Supporting Your Molecular Diagnostic Assay Development with OEM Commercial Supply Partnerships Todd HowrenAssociate Director, Business Development
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Navigating the Challenges of Molecular Diagnostic (MDx) Development
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Manufacture products
• ISO 9001, ISO 13485, GMP certified
• Custom configuration, QC, and packaging
• Capacity and scale
• Private labeling
• Global supply chain
Licensing and supply
agreements
• Long-standing expertise in agreements
• Out-licensing
• Change control
• Security of supply
Customize products
as needed
• Comprehensive development and customization capabilities
• Process control
• Pilot lab/prototyping capabilities
Select products from our portfolio
• Extensive collection of technologies and tools for genetic analysis
• Thermo Fisher Scientific
• Applied Biosystems
• Invitrogen
• Evaluate options and alternatives
How We Work With You: One Strategic Partner
Evaluate workflow needs
• Meet with our dedicated licensing and commercial supply team
• In-depth product and capabilities knowledge
• Confidentiality
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Navigating the Challenges of Molecular Diagnostic (MDx) Development
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Molecular Diagnostic Assays with Endpoint & Real-Time PCR Platforms
Samples and controls
Enzymes, master mix and assays
Instrument & Plastics Results Analysis+ +
• Gene expression
• Genotyping
• Copy number variation
• Pathogen detection/ quantitation
• Mutation detection
• Validated according to laboratory guidelines (CLIA, CAP, ISO)
• Limited to laboratory that developed the assay
• Exempt from premarket approval
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Lyo-ready DNA Polymerases and Reverse Transcriptases
The largest selection lyo-ready enzymes:
• Glycerol-free composition for lyophilization-compatible formulation
• Available in industry-leading brands (e.g., Platinum, Phusion, SuperScript and more)
• Supplied in bulk or custom sizes
• Manufactured in ISO 13485 certified facility
• Applications:• Real-time PCR, endpoint PCR• Genotyping & NGS• Component of master mix
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Single-Use System Manufacturing of DNA-free PCR Reagents
SUS
Leveraging our expertise in enzyme development, the DNA-free DNA polymerases and reverse transcriptases are manufactured using Single-Use System (SUS) technology
• Closed, controlled and disposable system
• Validated QC methods with detection limits 100x lower than competing “DNA-free” enzymes
• Manufactured in ISO 13485 certified facility
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SUS for Enzyme Production
Closed, controlled and disposable system: • Eliminated external contamination risks from operator and environment• Superior purification techniques used to remove host cell DNA to below detection limits
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Our Ongoing Commitment to Clinical Customers
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7500 F Real-time PCR Systems
7500 F Dx Real-time PCR System
QuantStudio 6/7 Systems
QuantStudio Dx Real-time PCR System
QuantStudio 3/5 Systems
QuantStudio 5 Dx Real-time PCR System
The QuantStudio 5 Dx Real-Time PCR System is coming soon. Product not yet CE-marked. Cannot be sold or put into service.
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QuantStudio 5 Dx -- A modern diagnostic instrument for today's smart labs
Intuitive touchscreen interface
Intuitive touchscreen interface
Multi-modal software for IVD and assay development
Multi-modal software for IVD and assay development
0.2mL VeriFlex Block
White LED opticsWhite LED optics
The QuantStudio 5 Dx Real-Time PCR System is coming soon. Product not yet CE-marked. Cannot be sold or put into service.
High performance 1.5 fold detection, 9 logs of linear range
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Continuing our innovation in Sanger Sequencing and Fragment Analysis, the SeqStudio Genetic Analyzer provides you an integrated experience:
• all-in-one cartridge for easy set up and reduced hands-on time
• ease of use with plug-and-play reagents, individualized protocolsand intuitive touchscreen
• flexibility for both sequencing and fragment analysis in a single run.
• run time of as little as 30 minutes for fast turnaround time
• high performance data for oncology and inherited disease research as well as microbial pathogen identification
Introducing Applied Biosystems™ SeqStudio™ Genetic Analyzer
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Faster timeto market
• Established IVD platforms may help enable a shorter path to compliance
• Experience developingIVD products
Partner rather than vendor
• Comprehensive custom development and manufacturing capabilities
• Timely technical support
• Dedicated OEM teams
• 25+ years in OEM business
Simplified supply chain
• Unrivaled breadth and depth of the portfolio
• Change control notifications
• Reserve lots
• Special payment terms
• Convey rights for commercial use
Securityof supply
• Comprehensive raw materials and process controls
• Multiple manufacturing sites
• Company reputation
• Financial stability
• Confidentialityobligations
Sustainable Partnership to Meet Your Needs
Quality and performance
• 40+ years in life sciences
• Robust quality systems
• ISO 9001, ISO 13485
• Openness to buyer audits
• Both RUO reagents andIVD instrumentations
The world leader in serving science
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