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FIND and Operational Research in HIV-Associated Tuberculosis

Rick O’Brien

Foundation for Innovative New Diagnostics, Geneva

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• 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

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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.

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Market access and distribution

Discovery and research

FIND SCOPE OF ACTIVITIES

FIND’s focusUpstream Downstream

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Development

Facilitate,co-fund,

co-develop

Evaluation

Regulatory-quality

lab & fieldtrials

DemonstrationLarge-scale

projectsmeasuring

feasibility andimpact on

disease control programs

Proof of principle

Product in box

EfficacyData

EffectivenessData

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Create network of public and private partnerships to create effective tests and demonstrate their effectiveness

FINDACTIVITY

Research

Liaison with funders, pharmaceutical and biotechnology companies, researchinstitutes and academia

Development

Evaluation

Regulatory quality lab and field trials

Demonstration Access

Liaise with funders, NGO’s, health ministries and agencies, e.g., GDF and GFATM

FIND focus

Industry approach

Proof of principle Product in box Efficacy data Effectiveness data

Facilitate, co- fund and co- develop

Large scale projects to measure feasibility and impact on disease control programs

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diagnostic question healthsystem level

1. Detection• Who shall be treated?• Is patient responding

2. Resolution• Change treatment for failure?

• Is the strain resistant?

3. Surveillance• Are programs effective?• Are there new strains?

Central lab• QC procedures & policies• strain typing

District lab • fill detection gap • resolve unclear cases• resistance testing

Health Center

(Clinic)

• Yes–No answer • medical monitoring

• easy & robust lab procedures • support for multiple health problems• universal platforms

• easy & robust lab procedures • support for multiple health problems• universal platforms

• dedicated POC devices• minimal skill requirements

• dedicated POC devices• minimal skill requirements

segmentation - diagnostic question vs. health system level

DETECTIONmore sensitive than smear !

RESOLUTIONfaster than

culture !

FIND product timeline

2005 2006 2007 20092008

Health center

District lab

Central labCurrent NAAT

TK

Fastplaque

Robust NAAT

MGIT

Breath test

Adapted AFB

Ag detection

Serology

Automated AFB

Simple NAAT

Devel

Development

Fea

Demonstration

Demonstration

Feasibility Development Evaluation

Demonstration Access

Feasibility Development Evaluation

Feasibility Development Evaluation

Feasibility Development Evaluation

Feasibility Development Evaluation

Feasibility AccessDevelopment Evaluation Demonstration

Evaluation Demonstration Access

Evaluation Demonstration

Access

Development Evaluation

Access

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FIND-BD MGIT Demonstration Projects

• Formal agreement with BD Dec 04– FIND to undertake CF and DST demo projects – BD to supply MGIT equipment/reagents at

“affordable” price to public sector in HBCs

• FIND objectives– Demonstrate feasibility and impact of MGIT – Provide data for WHO recommendations

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FIND-BD MGIT TB/HIV Case-Finding Demonstration Projects

• FIND-CREATE MOU Dec 04– MGIT culture in support of studies in Zambia,

South Africa, and Brazil

• Under discussion– GAP/PATH/Tanzania NTLP– WHO/CDC/RIT-JICA/FHI/Cambodia MOH– AMPATH (Eldoret, Kenya)