Chembio Diagnostics, Inc., is providing an update on the FDA Premarket Approval (PMA) application for its 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, 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 FDA approval of the PMA application. These efforts reflect the company’s continuing focus on both the achievement of the PMA milestone and the timing of ultimate approval with the CLIA waiver.
Chembio’s DPP HIV-Syphilis System is a single-use, 15-minute screening test for the simultaneous detection of antibodies to HIV types 1 and 2 and Treponema pallidum, the bacteria that causes syphilis. It uses a 10-microliter fingerstick sample of whole blood, venous whole blood or plasma. The test is highly sensitive and specific, has a built-in procedural control, can be stored at room temperature and has a shelf life of up to 24-months.
