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Revolutionizing TB Control with Innovation in New Diagnostics Dr Giorgio Roscigno Chief Executive Officer, 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 7 th, 2006

FIND’s Mission To accelerate the development, evaluation, and appropriate use of high-quality — yet 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. Upstream Discovery and research FIND’s focus Developmen t Evaluation Downstream Demonstratio n Market access POLICY and distribution

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

Biotech revolution = Diagnostic solutions for poverty related diseases Biotech revolution = Diagnostic solutions for poverty related diseases

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

Availability of diagnostic services Despite an average of 1. 7 microscopy centers per 100, 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 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 FIND system platforms appropriate solutions for all levels of health system example: TB 45 days 15 days Few hours Less than 1 hour 1 day

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