Chembio's SURE CHECK® HIV 1/2 Assay for Rapid Point-of-Care Detection of HIV Receives CE Mark Approval
Chembio Diagnostics, Inc. (Nasdaq: CEMI) a leader in point-of-care ("POC") diagnostic tests for infectious diseases, announced today that it's SURE CHECK® HIV 1/2 Assay has received CE Mark approval from European regulators. The SURE CHECK® HIV 1/2 Assay is now cleared for commercialization within the European Union (EU) for rapid, point-of-care detection of HIV. This product is FDA-approved and distributed in the U.S. as Clearview® COMPLETE HIV 1/2 by Alere NA. Chembio is currently working with commercialization partners in Europe and expects sales of the SURE CHECK® HIV 1/2 Assay in the EU by Q1 2014. France alone reported the administration of 5.2 million HIV tests (serological) in 2012. According to the European Centre for Disease Prevention and Control and the World Health Organization Regional Office for Europe, there were more than 28,000 new HIV diagnoses in 2011 in the EU and European Economic Area (EEA). The 2011 European HIV/AIDS surveillance report published by these groups concluded, “HIV infection is of major public health importance in Europe, with evidence of continuing transmission in specific populations with no clear signs of overall decrease.” “Chembio is dedicated to the development of superior diagnostics to enable rapid detection and early treatment of HIV and other infectious diseases,” stated Lawrence A. Siebert, chairman and CEO of Chembio. “This CE Mark allows us the opportunity to bring these important diagnostics to the European market, an area that continues to see a rise in HIV among certain significant populations. We are working with commercialization groups to support our launch of the SURE CHECK® HIV 1/2 Assay in Europe in the coming months. In addition, we continue to work with regulators in Europe to obtain CE Marks for several of our other diagnostic products this year including, our HIV 1/2 STAT-PAK® test, DPP® HIV 1/2 Oral Fluid test and DPP® Syphilis test.”
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