automated tb diagnosis robot microscope project development plan and background

ConsultASK Management Consulting LLC

H-1121 Budapest, Konkoly-Thege M. út 29-33. Tel.: +36-1-391-9400 FAX: +36-1-391-9409

Automated TB diagnosis Robot MicroscopeProject

Development Plan and Background

ConsultASK Ltd


H-1121 Budapest, Konkoly-Thege M. út 29-33. Tel.: +36-1-391-9400 FAX: +36-1-391-9409Facts about TB incidence

• With 8.8 Mi new cases annually and almost 2 Mi deaths, TB is still a leading mortality factor

• Overall, one-third of the world's population is currently infected with the TB bacillus.

• 10% of people who are infected with TB bacilli (but who are not infected with HIV) become sick or infectious at some time during their life.

• TB is the leading killer of people with HIV• 27 countries account for 85% of MDR-TB cases• There is huge need for tools that correspond to the medical

need at affordable price (WHO report)• Annually over USD 1 Bi wss spent on TB diagnostics in

2009, and the sum is increasing

Source WHO

Nearly 5,000 people die from TB daily, a curable disease in most cases !!



Further Facts

• The most commonly used sputum smear microscopy is more than 100 years old, but is the most affordable for the majority of HBC countries

• It is also the most ineffective, detects only half of patients tested with currently used manual method, mainly due to low sensitivity, lack of well trained personel, tiring factor.

• The vast majority of TB patients can be successfully treated with existing drugs,

• Delay in assessing proper diagnostics costs time, money and leads to continued transmission of infections

• TB drains 12 billion USD from the annual incomes of the poorest communities

• Loss of productivity attributable to TB approaches 7% of GDP in some countries

Source WHO

IT IS NOT AN UNCURABLE DISEASE!

There is urgent need for more accurate and rapid diagnostic tests (WHO, FIND)


H-1121 Budapest, Konkoly-Thege M. út 29-33. Tel.: +36-1-391-9400 FAX: +36-1-391-9409The Shocking Facts about TB



TB Burden

Source WHO



Sputum smear diagnosis of TB:

Light source microscopy ZN staining

• The fastest and cheapest available method

• Good specificity

• Weak sensitivity

• Trained staff needed

• Time consuming,10– 15 min./slide

Fluorescence microscopy

• Increased sensitivity

• More expensive

• Faster, less tiresome

• Maintenance requirements

(mercury vapour lamps)



Current market (WHO)

Source WHO



Current smear market(WHO)

Source WHO



The Global Revised WHO Plan 2011-2015



Current smear market

Source WHO



Market cont.

• Current assumptions:

– Number of microscopy centers ~70K (58K public, 12K private)

– 20% of microscopes should be replaced by LED by 2015 (WHO)

– 1 smear laboratory/ 100 000 population should be reached by 2015 (WHO)

Source WHO

- Potential- Potential smear smear marketmarket 200 M tes 200 M teststs (WHO) (WHO)


H-1121 Budapest, Konkoly-Thege M. út 29-33. Tel.: +36-1-391-9400 FAX: +36-1-391-9409Fluorobot: the fully

automated solution

• Based on the traditional smear microscopy principle• LED fluorescent technique• Fully automated

– Input / output and moving of the slides

– Image capturing and analysis

– Intelligent bacterium recognition algorythms

• Long walk away time• Low cost, robust design suitable for high incidence, high burden

countires


H-1121 Budapest, Konkoly-Thege M. út 29-33. Tel.: +36-1-391-9400 FAX: +36-1-391-9409Main Features

• Illumination system using LED technology, much less sensitive, longer lifetime and cheaper than mercury vapour lamps

• Robust, cost effective X-Y movement • Special, fast focusing system • Cost effective, dedicated simplified microscope with only one

magnification• Special image processing and pattern recognition algorithms used

for bacteria identification • Walk away system, batch processing of 100 – 250 slides• Standardised quality, no tiring effect• No trained staff needed


H-1121 Budapest, Konkoly-Thege M. út 29-33. Tel.: +36-1-391-9400 FAX: +36-1-391-9409Major milestones

• Feasibility Study in Q1 2009• Functional Model stage was successfully reached Q4 2009• Laboratory Sample Stage was reached at Q3 2010• „Proof Of Principle” study was conducted at German TB Reference

Laboratory, WHO Supranational Laboratory at Borstel led by Dr. Rüsch-Gerdes in September 2010, with positive outcome

• „Letter Of Intent” was signed with FIND (Foundation for Innovative New Diagnostics, Geneva) in November 2010

• Financing Partner is searched in, to carry the project through Prototype Development (Q1 2012) and Validation (Q2 2013)

• Industrialization and Test Production Planned Q3 2013• GoLive of final product (and disposable) planned Q4 2013



The new Laboratory Sample



What we propose

• Finalize potential disposable kit (staining kit, slide, slide holder…)

• Based on the results decide to continue or abort project

• Join the actual state of the development project and finance further development to Milestone III.)

• Continue to MS IV.

• Continue dedicated disposable development

• If successful continue with ConsultASK on industrialization of product

• Consider setting up production in Hungary (or partly or wholly in more cost effective environment if necessary) and supply of disposable, with a 3rd round financing


H-1121 Budapest, Konkoly-Thege M. út 29-33. Tel.: +36-1-391-9400 FAX: +36-1-391-9409The Road

behind our development team

• Core team has more than 15 years experience in medical imaging and robotic microscopy

• Main project in the early 90s was the Seditron urine sediment analyzer developed and produced for Boehringer Mannheim

automated tb diagnosis robot microscope project development plan and background

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