Chembio Diagnostics this week said it has received a three-year $2.9 million Small Business Innovative Research Phase II grant from the National Institutes of Health to further develop its protein-based point-of-care tuberculosis test.
The grant, which began March 1, follows on Phase I work in which the company, in collaboration with the Infectious Disease Research Institute, developed a prototype of the test using its Dual Path Platform chromatographic immunoassay technology.
The test uses a panel of polyepitope fusion proteins based on antigens involved in the antibody response to pulmonary tuberculosis to diagnose the disease. According to Chembio, the Phase I prototype showed sensitivity of 81 percent and specificity of 95 percent in pilot studies of patients with active tuberculosis in endemic regions.
Under the terms of the grant, Chembio will receive $1,842,700 of the award, assuming it continues over the full three years. IDRI would receive the balance of the award as a subcontractor to Chembio. The funding will be granted in sums of roughly $967,000 each year and is subject in the second and third years to satisfactory progress and availability of funds.
In addition to its work on tuberculosis, Chembio has on the market two US Food and Drug Administration-approved rapid HIV tests as well as diagnostics for syphilis and Chagas disease.