Chembio receives grant for rapid TB test

Chembio Diagnostics, Inc., has received a three year, $2.9 million small business innovative research phase II grant from the United States Nation Institutes of Health to continue developing a rapid serological test for active tuberculosis.

The test, which is moving into phase II of its development, is also accurate, simple and cost-effective. It is particularly designed so that it can be used in resource-limited settings. The prototype used the innovative Dual Path Program technology that Chembio patented and developed, along with a large panel of novel recombinant antigens identified by the Infectious Disease Research Institute in Seattle.

"We look forward to completing the phase II work so that we can provide a practical tool in the diagnosis of tuberculosis,” Lawrence A. Siebert, president of Chembio, said. “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.”

The phase I studies showed that it was indeed feasible to develop an accurate and rapid test with a sensitivity of 81 percent and a specificity of 95 percent. Phase II looks to develop the speed of the test to be around 15 minutes while optimizing the test for other factors to prepare for regulatory approval and commercialization.

"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,” Dr. Steven G. Reed, founder of IDRI and the head of research and development, said. “IDRI's collaboration with Chembio is a nice example of how public private partnerships translate good science into field-appropriate solution."

Tuberculosis infects an estimated two billion people worldwide with several million new cases each year.