Chembio Diagnostics Provides Update on Regulatory Status of DPP HIV-Syphilis System
Chembio Diagnostics, Inc. (CEMI)
Last chembio diagnostics, inc. earnings: 3/12 04:07 pm
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Source: GlobeNewswire
MEDFORD, N.Y., March 03, 2020 (GLOBE NEWSWIRE) -- Chembio Diagnostics, Inc. (Nasdaq: CEMI), a leading point-of-care diagnostics company focused on infectious diseases, is providing an update on the FDA Premarket Approval (PMA) application for Chembio’s DPP HIV-Syphilis Assay System. The FDA has confirmed that, of the items that had been open for the PMA review, the Syphilis arm of the study was acceptable, as were the results as they relate to the inclusion of pregnant women. As indicated by the FDA on February 21, 2020, the only remaining item requested of the company is to repeat the reproducibility study, as one of the sites in the trial reported greater variability compared to the other sites. Chembio has both addressed and discussed with the FDA what it deems to be the underlying cause of the variance, and it has already initiated the reproducibility study required by the FDA. In parallel, the company has accelerated the studies for a CLIA waiver, which can be submitted upon FD
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