Chembio Diagnostics Provides Update on FDA Submission of DPP HIV-Syphilis Test
Chembio Diagnostics, Inc. (CEMI)
Last chembio diagnostics, inc. earnings: 3/12 04:07 pm
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Source: GlobeNewswire
MEDFORD, N.Y., Jan. 02, 2020 (GLOBE NEWSWIRE) -- Chembio Diagnostics, Inc. (Nasdaq: CEMI), a leading point-of-care diagnostics company focused on infectious diseases, today provided an update on its Premarket Approval application submission to the U.S. Food and Drug Administration (FDA) for the DPP HIV-Syphilis System. The company anticipates FDA approval of the DPP HIV-Syphilis System, which includes the DPP HIV-Syphilis test and DPP Micro Reader, during the first quarter of 2020. “Our clinical study, which included the prospective enrollment of over 2,500 subjects, demonstrated that the DPP HIV-Syphilis System met the performance requirements established with the FDA,” said John Sperzel, Chembio’s Chief Executive Officer. “We provided the additional studies requested, which included data on pregnant women, and expect a decision from the FDA within two months.” Chembio’s DPP HIV-Syphilis System is a single-use, 15-minute screening test for the simultaneous detection of antibodies
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