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Chembio Awarded Phase II NIH Grant for Rapid TB Test on DPP® Platform

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Chembio Diagnostics, Inc. has been awarded a three-year $2.9 million Small Business Innovative Research (SBIR) Phase II grant from the United States National Institutes of Health (NIH) to continue development of a simple, rapid, accurate, and cost-effective serological test for active tuberculosis that can be utilized in resource-limited settings.

Chembio developed a prototype of this test in the Phase I work in collaboration with the Infectious Disease Research Institute; this collaboration will continue in this second phase of the research and development grant as well. The grant is effective March 1, 2011.

Tuberculosis is a chronic infectious disease, with an estimated 2 billion people currently infected worldwide and several million new cases each year. Current methods of diagnosis are slow, unreliable, and/or impractical in the field settings where the disease burden is the greatest. New diagnostics are urgently needed to address this global health problem by improving control programs.

The prototype test developed during the Phase I work uses the innovative Dual Path Platform (DPP®) technology developed and patented by Chembio, together with selected antigens from a large panel of novel recombinant antigens identified at IDRI, a Seattle-based biotechnology research organization dedicated to technologies that address diseases in the developing world.

Chembio is budgeted to receive approximately 63.5% of the awarded amount, or approximately $1,842,700, if award funding continues over the full three years as is expected; IDRI would receive the balance as a subcontractor to Chembio. The grant award budget is approximately equal in each grant year, or approximately $967,000 per year. As in all such grants, award funding in the second and third years is subject to satisfactory progress and availability of funds.

The Phase I studies demonstrated the feasibility of developing a rapid and accurate test for tuberculosis with required diagnostic performance characteristics (sensitivity < 80%, specificity < 95%). Scientists at Chembio and IDRI have identified novel serodiagnostic targets involved in the antibody response in patients with pulmonary tuberculosis and designed a set of polyepitope fusion proteins.

Integrating these high-performing antigens in the Chembio proprietary DPP® technology resulted in developing a test prototype showing sensitivity of 81% and specificity of 95% in pilot evaluations of patients with active tuberculosis in endemic regions. In Phase II, the proposed rapid (15 minutes) point-of-care DPP® test for tuberculosis will be fully developed, optimized, and evaluated in multi-center clinical trials in several countries, followed by validation of production protocols, preparation for regulatory approval and commercialization.

Lawrence A. Siebert, Chembio's President, commented, "We look forward to completing the Phase II work so that we can provide a practical tool in the diagnosis of tuberculosis. We appreciate the outstanding work that Dr. Konstantin Lyashchenko, the Chembio TB project team and our collaborators at IDRI, have all done to receive this Phase II grant and to address a large global health need."

Dr. Steven G. Reed, IDRI's Founder and Head of Research and Development, indicated, "We at IDRI see this Phase II funding as validation that our proprietary reagents, combined with Chembio's DPP® technology, can contribute to more effective management of tuberculosis - and a reduction in the burden of this dangerous disease. IDRI's collaboration with Chembio is a nice example of how public private partnerships translate good science into field-appropriate solution."