The World’s first robotic, LED based , smear microscope for TB screening!

ConsultASK Management Consulting LLC

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

The World’s first

robotic, LED based, smear microscope

for TB screening!

The Tireless Technician!



Facts about the TB burden

• With 8.8 Mi new cases annually and almost 1,5 Mi deaths, TB is still a leading mortality factor

• TB is the leading killer of people with HIV• 22 HBC (High Burden Country) countries account for 80% of the

incidence• Annually over USD 1 Bi was spent on TB diagnostics in 2009, and the

sum is increasing • 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• In 2009 there were 9,7 million orphan children a a result of TB deaths

Source WHO

Nearly 4,000 people die from TB daily, a curable disease in most cases !!


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

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

• Todays TB drugs are more then 40 years old and have to be taken for 6-9 months

• Todays TB vaccine is more than 85 years old• Delay in assessing proper diagnostics costs time, money and leads to

continued transmission of infectionsThere is huge need for tools that correspond to the medical need at affordable price (WHO report)

Source WHO

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



TB Burden in 2009

Source WHO



TB Diagnostics market in 2009

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

Traditional

Fluorescence microscopy

• Increased sensitivity

• More expensive

• Faster, less tiresome

• Maintenance requirements

(mercury vapour lamps)



The smear market in 2009

Source WHO


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

WHO Plan 2011-2015



Microscopy market in 2009

Source WHO



Market cont.

• Current assumptions:

– Number of microscopy centers was ~70K (58K public, 12K private) in 2009

– 1 smear laboratory/ 100 000 population

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

by LED by 2015 (WHO)

Source WHO

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



Fluorobot: the only fully automated, dedicated solution

• Based on the traditional smear microscopy principle• Fully automated

– Input / output and moving of the slides– Image capturing and analysis– Intelligent bacterium recognition algorythms

• Low cost, robust design suitable for high incidence, high burden countires

• Huge walk away window, batch processing of 100 – 250 slides• Small footprint• High throughput (25 smears/hour)• Competitive cost/test



Main 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, simplified light path, optimised for a single magnification• Dedicated image processing and pattern recognition algorithms used

for bacteria identification • Classification follows WHO reccomendation (neg., scanty, +, ++, +++)• Standardised quality, no tiring effect• Images are stored, can be transmitted, archived, revisited • Opening new Quality Control possibilities• No trained microscope reading staff needed



Major 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

• Project was exhibited at MEDICA 2012 Dusseldorf and Medical Fair India 2013 in New Delhi, with huge success

• Strategic Partner is searched, to carry the project through Prototype Development (Q3 2013) and Validation (Q4 2013)

• Industrialization and Test Production Planned Q3 2014• GoLive of final product (and disposable) planned Q4 2014



The 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


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

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The World’s first robotic, LED based , smear microscope for TB screening!

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