CE Mark Approval Granted for Chembio Diagnostics, Inc. (CEMI) SURE CHECK HIV 1/2 Assay for Rapid Point-of-Care Detection of HIV
Point-of-care (POC) diagnostics test leader Chembio Diagnostics announced that European regulators have granted CE Mark approval for the company’s SURE CHECK HIV 1/2 Assay. Now cleared for commercialization within the European Union for rapid, point-of-care detection of HIV, the SURE CHECK HIV 1/2 Assay is also FDA approved and is being distributed in the United States by Alere NA as Clearview COMPLETE HIV 1/2. Currently, Chembio is working with commercialization partners in Europe and anticipates sales of the SURE CHECK HIV 1/2 Assay in the E.U. by Q1 of 2014. In France alone, the administration of 5.2 million HIV tests…