Point-of-care diagnostic tests leader Chembio Diagnostics announced it has received its first purchase order for the DPP HIV-Syphilis Assay from its Mexican distributor. The DPP HIV-Syphilis Assay is based on Chembio’s patented Dual Path Platform (DPP), a POCT platform ideally suited for multiplexing that, in this case, adds a syphilis biomarker to Chembio’s DPP HIV 1/2 Test, which has already been approved by the FDA. Adding this biomarker has resulted in a unique finger-stick whole blood test that helps reduce the mother-to-child transmission of both HIV and syphilis. Throughout the world, the incidence of pregnant women being infected with syphilis is higher than for HIV, and prenatal testing is a crucial tool in preventing the transmission of both of these diseases to unborn children.
The DPP HIV-Syphilis Assay has additionally been approved for inclusion on the U.S. Agency for International Development (USAID) waiver list, which makes the product eligible for procurements by U.S. government-funded global health programs like the President’s Emergency Plan for AIDS Relief (PEPFAR) and its associated programs and stakeholders. Receiving USAID approval involves product performance laboratory studies conducted by the International Laboratory Branch of the United States Centers for Disease Control (CDC) across multiple production lots to verify consistent performance. Chembio expects the results from the CDC’s evaluation to be forthcoming. The company is additionally pursuing CE Marking and FDA approval of the DPP HIV-Syphilis Assay.
The purchase order from Mexico comes on the heels of the favorable evaluation of the sensitivity and specificity of the assay by Mexico’s Institute of Epidemiological Diagnosis and Reference (InDRE). The product performed with 100 percent sensitivity and 100 percent specificity on all samples in the InDRE’s testing.
To further product expansion into global markets, Chembio is progressing toward receiving World Health Organization approval for procurement by other large donor-funded global health screening programs. Chembio is additionally working directly in several regions of the world to develop and inform stakeholders about the availability of the DPP HIV-Syphilis Assay.
For more information, visit www.chembio.com
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