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Chembio Diagnostics Plans FDA Submission for HIV-Syphilis Test in Q1 2018

NEW YORK (360Dx) – Chembio Diagnostics said today that it plans to submit a pre-market approval application with the US Food and Drug Administration during the first quarter of 2018 to support commercialization of its first point-of-care HIV-syphilis assay in the US. 

The expected submission comes on the back of the firm completing a US clinical trial evaluating the system.

The firm's dual-path-platform (DPP) immunoassay-based HIV-syphilis system is a single-use, 15-minute screening test for the detection of antibodies to HIV types 1 and 2 and the causative agent for syphilis Treponema pallidum. It uses a 10 µl fingerstick of whole blood, venous whole blood, or plasma. The firm said that the test is highly sensitive and specific, has a built-in procedural control, can be stored at room temperature, and has up to a 24-month shelf life.

Chembio CEO John Sperzel said in a statement that the firm "is aggressively pursuing a three-pronged growth strategy," which includes the strengthening of its sexually transmitted disease business, continued development of its fever disease portfolio, and additional pursuit and development of new and existing technology collaborations.

Earlier this week, Chembio said that it has entered a collaboration with biopharma company AstraZeneca to develop a point-of-care diagnostic test that detects an undisclosed biomarker.

And earlier in the month, the firm announced that it had received a commitment from Bio-Manguinhos, a subsidiary of Brazil's Oswaldo Cruz Foundation, for the purchase of $8.5 million worth of materials related to Chembio's HIV and Leishmania point-of-care immunoassays.