Consult. ASK 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 Microscope Project Development Plan and Background Consult. ASK Ltd
Consult. ASK Management Consulting LLC H-1121 Budapest, Konkoly-Thege M. út 29 -33. Tel. : +36 -1 -391 -9400 FAX: +36 -1 -391 -9409 Facts 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 Nearly 5, 000 people die from TB daily, a curable disease in most cases !! Source WHO
Further Facts Consult. ASK Management Consulting LLC H-1121 Budapest, Konkoly-Thege M. út 29 -33. Tel. : +36 -1 -391 -9400 FAX: +36 -1 -391 -9409 • 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, IT IS NOT AN UNCURABLE DISEASE! • 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 There is urgent need for more accurate and rapid diagnostic tests (WHO, FIND) Source WHO
Consult. ASK Management Consulting LLC H-1121 Budapest, Konkoly-Thege M. út 29 -33. Tel. : +36 -1 -391 -9400 FAX: +36 -1 -391 -9409 The Shocking Facts about TB
Consult. ASK Management Consulting LLC TB Burden H-1121 Budapest, Konkoly-Thege M. út 29 -33. Tel. : +36 -1 -391 -9400 FAX: +36 -1 -391 -9409 Source WHO
Consult. ASK Management Consulting LLC H-1121 Budapest, Konkoly-Thege M. út 29 -33. Tel. : +36 -1 -391 -9400 FAX: +36 -1 -391 -9409 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)
Consult. ASK Management Consulting LLC Current market (WHO) H-1121 Budapest, Konkoly-Thege M. út 29 -33. Tel. : +36 -1 -391 -9400 FAX: +36 -1 -391 -9409 Source WHO
Current smear market (WHO) Consult. ASK Management Consulting LLC H-1121 Budapest, Konkoly-Thege M. út 29 -33. Tel. : +36 -1 -391 -9400 FAX: +36 -1 -391 -9409 Source WHO
The Global Revised WHO Plan 2011 -2015 Consult. ASK Management Consulting LLC H-1121 Budapest, Konkoly-Thege M. út 29 -33. Tel. : +36 -1 -391 -9400 FAX: +36 -1 -391 -9409
Current smear market Consult. ASK Management Consulting LLC H-1121 Budapest, Konkoly-Thege M. út 29 -33. Tel. : +36 -1 -391 -9400 FAX: +36 -1 -391 -9409 Source WHO
Market cont. Consult. ASK Management Consulting LLC H-1121 Budapest, Konkoly-Thege M. út 29 -33. Tel. : +36 -1 -391 -9400 FAX: +36 -1 -391 -9409 • Current assumptions: – Number of microscopy centers ~70 K (58 K public, 12 K private) – 20% of microscopes should be replaced by LED by 2015 (WHO) – 1 smear laboratory/ 100 000 population should be reached by 2015 (WHO) - Potential smear market 200 M tests (WHO) Source WHO
Consult. ASK Management Consulting LLC H-1121 Budapest, Konkoly-Thege M. út 29 -33. Tel. : +36 -1 -391 -9400 FAX: +36 -1 -391 -9409 Fluorobot: 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
Consult. ASK Management Consulting LLC H-1121 Budapest, Konkoly-Thege M. út 29 -33. Tel. : +36 -1 -391 -9400 FAX: +36 -1 -391 -9409 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, 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
Consult. ASK Management Consulting LLC H-1121 Budapest, Konkoly-Thege M. út 29 -33. Tel. : +36 -1 -391 -9400 FAX: +36 -1 -391 -9409 Major milestones • • Feasibility Study in Q 1 2009 Functional Model stage was successfully reached Q 4 2009 Laboratory Sample Stage was reached at Q 3 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 (Q 3 2012) and Validation (Q 1 2013) Industrialization and Test Production Planned Q 2 2013 Go. Live of final product (and disposable) planned Q 4 2013
Consult. ASK Management Consulting LLC The new Laboratory Sample H-1121 Budapest, Konkoly-Thege M. út 29 -33. Tel. : +36 -1 -391 -9400 FAX: +36 -1 -391 -9409
Consult. ASK Management Consulting LLC What we propose H-1121 Budapest, Konkoly-Thege M. út 29 -33. Tel. : +36 -1 -391 -9400 FAX: +36 -1 -391 -9409 • Join the actual state of the development project and finance further development to Milestone III. ) • Based on the results decide to continue or abort project • Continue to MS IV. • Continue dedicated disposable development • Finalize potential disposable kit (staining kit, slide holder…) • If successful continue with Consult. ASK 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 3 rd round financing
Consult. ASK Management Consulting LLC H-1121 Budapest, Konkoly-Thege M. út 29 -33. Tel. : +36 -1 -391 -9400 FAX: +36 -1 -391 -9409 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 90 s was the Seditron urine sediment analyzer developed and produced for Boehringer Mannheim
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