Revolutionizing TB Control with Innovation in New Diagnostics Dr Giorgio Roscigno Chief Executive Officer, FIND Reversing the Tide: the End of Tuberculosis, Low Memorial Library, Columbia University, NY Tuesday, March 7th, 2006

Market access and distribution Discovery and research FIND’s focusUpstreamDownstream Developmen t Evaluation Demonstratio n POLICY FIND’s Mission To accelerate the development, evaluation, and appropriate use of high-quality — yet affordable — diagnostic tools for poverty related diseases in developing countries.

Syndromic treatment No treatment Continued illnessContinued transmission Waste of resources Drugresistance Lack of diagnosis Public healthIndividual health Overall impact Increasing burden of disease Breakdown in disease control Health system failure Mis- or over-treatment Drug side effects The Importance of Diagnostics

Biotech revolution = Diagnostic solutions for poverty related diseases

Simple one-step testing in 15 minutes Accurate, quantitative readout Simultaneous results from multiple markers Portable, low maintenance instrument Built-in quality control Complex, slow tasks Inaccurate, qualitative readout Single marker, single disease Heavy, high maintenance instruments Absent quality control Major Markets Rest of World

Availability of diagnostic services Despite an average of 1.7 microscopy centers per 100,000 population among the 22 high-burden countries, logistical problems (missing or broken materials, strikes, lack of trained personnel) make access to microscopic diagnosis difficult, and nearly 5 million incident TB cases including 2,172,000 smear-positive cases and 2,544,000 smear negative cases are either undetected or unreported.

Current global direct expenditures on TB diagnostic tests The diagnostic yield of this expenditure is limited, with only 19% of all incident TB cases detected and reported as smear-positive.*

FIND system platforms appropriate solutions for all levels of health system example: TB 45 days 5 days 15 days 5 days 1 day Few hours Less than 1 hour

Diagnostics Working Group: Stop TB Partnership Timeline for delivery: New diagnostic tests Rapid culture and DST 2006 MDR phage detection 2007 Automated molecular test: 2008 Improved microscopy 2006 Simplified molecular test 2008 POC test for active TB 2010 Predictive test for latent TB 2012