FIND Ongoing Activities What’s in the pipeline for Rapid DST? WHO Stop TB Department Supranational Reference Laboratory Network Meeting Paris, October 2005

FIND was established in 2003 with a grant from the Bill and Melinda Gates Foundation FIND is based in Geneva as a Swiss tax-exempt foundation FIND is the only public / private partnership wholly dedicated to improved diagnostic technologies for infectious disease endemic in developing countries FIND’s initial focus is on tuberculosis Background and History

FIND’s Mission FIND’s mission is to accelerate the development, evaluation, and appropriate use of high-quality yet affordable diagnostic tools for infectious diseases in developing countries.

Purpose Case Detection Drug susceptibility testing Latent TB Infection Test Indications Detect pulmonary TB with high bacterial load (SS+) Detect pulmonary TB with low bacterial load (SS -, Cx +) Detect extra-pulmonary and pediatric TB Detect MDR-TB for treatment Detect MDR-TB for surveillance Detect LTBI for surveillance Detect LTBI for treatment Proposed Priority # 1 # 2 # 3 # 4 # 7 # 5 # 6

Market access and distribution Discovery and research FIND SCOPE OF ACTIVITIES FIND ’sfocusUpstreamDownstream - Development Facilitate, Co-fund, Co-develop Evaluation Regulatory Lab and Field Trials Demonstration Large-scale Projects Measuring Feasibility and Impact Proof of principle Product in box Efficacy Data Effectiveness Data

FIND’s Diagnostic Pipeline

FIND Demonstration Projects Large scale implementation in program settings of tests that perform well in evaluation studies Objective –To provide information that will enable technical bodies (e.g., WHO) to recommend test in NTPs –To provide data to convince MoHs and Donors to purchase in implement test Main outcome measures: feasibility, impact, and cost-effectiveness Provide opportunities for partnership building

FIND-BD MGIT Demonstration Projects MGIT is rapid and sensitive liquid culture and DST system widely used in industrialized countries Formal agreement with BD Dec 2004 –FIND to undertake case finding and DST demonstration projects –BD to supply MGIT equipment/reagents at “affordable” price to public sector in HBCs that could be used for further assessments in high HIV settings FIND objectives –Demonstrate feasibility and impact of MGIT –Provide data for WHO recommendations

FIND-BD MGIT DST Demonstration Projects Focused on improved detection of MDR TB patients in DOTS-Plus Projects WHO/GLC assisted in planning and site identification Three sites selected –Nukus, Uzbekistan (MSF-Holland) –Katmandu, Nepal (GENETUP) –Samara Oblast, RF (HPA/UK) Close collaboration with CDC/Atlanta –Protocol development –Site monitoring –Links with similar project in Orel Oblast

Evaluation Study of Test for Rapid Diagnosis of Rifampin-Resistant TB Phage replication assay developed by Biotec with results available in 48 hours Preliminary data showing high correlation with gold standard RIF DST on solid media FIND evaluation in Peru (Cayetano Univ & INS) Enrolling AFB+ patients (1000 new/250 re-Rx) Preliminary results –95% sensitivity and specificity for dx of MDR TB –High contamination rate with assay being addressed with antibiotic supplement –Planning for demonstration projects underway