Tuesday, February 21, 2017

Chembio’s DPP® HIV-Syphilis Assay Receives CE Mark for Simultaneous Point-of-Care Detection of HIV and Syphilis

Chembio Diagnostics, Inc. (CEMI), a leader in point-of-care (POC) diagnostic tests for infectious diseases, announced that it has received a CE mark for its DPP® HIV-Syphilis combination assay. The Chembio DPP® HIV-Syphilis Assay is now cleared to be marketed and sold within the member states of the European Union and the Caribbean region, except for Puerto Rico.

The Chembio DPP® HIV-Syphilis Assay is a single-use, rapid screening test for the detection of antibodies to HIV types 1 and 2 and syphilis Treponema pallidum using fingerstick whole blood, venous whole blood, serum, or plasma. The test requires a small 10 µl blood sample, is highly sensitive and specific, provides results in as little as 15 minutes, has a built-in procedural control, can be stored at room temperature, and has up to a 24-month shelf life.

John Sperzel, Chembio's Chief Executive Officer, commented, "We are pleased to receive a CE mark for our DPP® HIV-Syphilis Assay, which allows us to market and sell the test in Europe and the Caribbean region, except for Puerto Rico. We believe the DPP® HIV-Syphilis Assay can play a role in the global initiative to reduce transmission of HIV and syphilis to unborn children, as well as to screen certain populations to address growing HIV and syphilis co-infection rates."

Co-infection rates of HIV and syphilis are on the rise and, according to the Centers for Disease Control and Prevention, there is an estimated two-to-five-fold increased risk of contracting HIV if exposed to that infection when syphilis is present. Further, an estimated two million pregnancies annually are affected by mother-to-child-transmission of HIV and/or syphilis, resulting in high rates of stillbirth, spontaneous abortion, low birth weight and perinatal death. Congenital syphilis is a preventable disease, which could be significantly reduced through effective prenatal screening, and treatment of infected pregnant women.

"We intend to leverage our patented DPP® platform to deliver diagnostic tests that are most needed in each corner of the world. In the U.S., our goal is to bring our DPP® HIV-Syphilis Assay to market as quickly as possible, as there currently are no other such combination tests available in the U.S. market. We plan to complete a U.S. clinical trial for our DPP® HIV-Syphilis Assay and file for U.S. regulatory approval in early 2017.  In addition to our receipt of a CE mark for the DPP® HIV-Syphilis Assay, we have previous regulatory approvals in Mexico and Brazil, and we are working to obtain approvals in certain Southeast Asia countries, following our recent acquisition of Malaysia-based RVR Diagnostics,” added Sperzel.


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