NEW YORK – Chembio Diagnostics today announced that it has entered into a collaboration with Shire Human Genetic Therapies, a subsidiary of Takeda Pharmaceutical, to develop a quantitative point-of-care diagnostic test to detect an undisclosed biomarker.
Under the terms of the agreement, Medford, New York-based Chembio will receive funding from Takeda subject to satisfying certain milestones to develop a test that leverages Chembio's Dual-Path Platform (DPP) chromatographic immunoassay and hand-held optical analyzer.
Specific financial and other terms of the agreement were not disclosed.
Tokyo-based Takeda is focused on oncology, gastroenterology, and neuroscience therapeutics and vaccines. Chembio said that the development of the POC test will build upon Takeda's technical research on a set of biomarkers, and the test is expected to provide quantitative results in about 15 minutes from a 10uL drop of fingerstick blood.
The DPP platform uses the same technology as the company's DPP HIV 1/2 Assay, which has achieved regulatory approvals including FDA clearance, CLIA-waiver, World Health Organization prequalification, CE marking, and Brazilian health regulatory approval from Anvisa, the firm noted.