MEDFORD, N.Y., Feb. 10, 2014 (GLOBE NEWSWIRE) -- Chembio Diagnostics, Inc. (Nasdaq:CEMI) a leader in point-of-care diagnostic tests for infectious diseases, today provided an update on its discussions with the U.S. Food and Drug Administration (FDA) concerning the company’s CLIA waiver application for its DPP® HIV 1/2 Assay. The DPP® HIV 1/2 Assay was approved by the FDA for professional use under an approved Pre-Marketing Application in December 2012. During 2013 untrained user studies were performed in support of a CLIA waiver application which was filed with the FDA at the end of November. During a recent discussion, the FDA indicated that additional new infections should be detected to strengthen Chembio’s data that the DPP HIV 1/2 Assay performs equivalently in the hands of the untrained user as compared to the professional user. Chembio is currently working with the FDA to define the specific additional requirements necessary for satisfactory completion of the CLIA waiver application.
Help employers find you! Check out all the jobs and post your resume.
