CEMI - Chembio Diagnostics +10% on FDA approval for DPP HIV-Syphilis System

The FDA has approved Chembio Diagnostics' (CEMI) Premarket Approval ((PMA)) application for the DPP HIV-Syphilis System including, a multiplex single-use test, and the DPP Micro Reader optical analyzer. It is being offered in the U.S. immediately. Under the PMA, the DPP HIV-Syphilis System is approved for use by trained professionals in point-of-care and laboratory settings to aid in the diagnosis of HIV and syphilis infections. Chembio’s DPP HIV-Syphilis System is a 15-minute test, designed to detect antibodies to HIV types 1 and 2 and Treponema pallidum, the bacteria that causes syphilis.Shares are up 10% premarket.

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Chembio Diagnostics +10% on FDA approval for DPP HIV-Syphilis System