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FIND Ongoing Activities What’s in the pipeline for Rapid DST?

FIND Ongoing Activities What’s in the pipeline for Rapid DST?. WHO Stop TB Department Supranational Reference Laboratory Network Meeting Paris, October 2005. Background and History. FIND was established in 2003 with a grant from the Bill and Melinda Gates Foundation

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FIND Ongoing Activities What’s in the pipeline for Rapid DST?

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

  2. Background and History • 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

  3. 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.

  4. Purpose Test Indications Proposed Priority Case Detection Drug susceptibility testing Latent TB Infection • 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 • # 1 • # 2 • # 3 • # 4 • # 7 • # 5 • # 6

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

  6. FIND’s Diagnostic Pipeline

  7. 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

  8. 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

  9. 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

  10. 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

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