Chembio Diagnostics, Inc., supplier of point-of-care diagnostic tests for infectious diseases, has 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 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 that 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.
The company had anticipated that the CLIA waiver would be granted by the end of the first quarter of 2014. The FDA's recent request will delay issuance of the waiver. A new anticipated timetable will be announced when the company believes it is in a reasonable position to do so. Learn more about the Chembio DPP HIV 1/2 Assay.