Small Business Grant Awarded for Tuberculosis Test

Mycobacterium tuberculosis bacteria (CDC)

Chembio Diagnostics Inc. in Medford, New York has received a three-year $2.9 million Small Business Innovative Research (SBIR) grant from the National Institutes of Health (NIH) to continue development of a simple, rapid, inexpensive, and accurate blood serum test for tuberculosis. The grant funds further development of the test, following an earlier SBIR grant to build a prototype.

Chembio is collaborating on this project with the Infectious Disease Research Institute (IDRI), a biotechnology research institute in Seattle, Washington. The test is designed to diagnose tuberculosis under under field conditions such as in developing countries, where many tuberculosis cases are found. IDRI has experience with technologies addressing diseases in developing countries.

The prototype test developed during the the first phase of the work uses the Chembio’s platform technology, together with antigens from a large panel of new recombinant antigens identified at IDRI. In the next phase, the proposed 15-minute, point-of-care test for tuberculosis will be fully developed, optimized, and evaluated in multi-center clinical trials in several countries. Validation of production protocols, preparation for regulatory approval, and commercialization are expected to follow the clinical trials.

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 considered slow, unreliable, and/or impractical in field settings where the disease burden is often the greatest.

Read more: U.K. Partnership to Research TB Testing Methods

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