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 (serological) was reported in 2012, and there were more than 28,000 new HIV diagnoses in the EU and European Economic Area (EEA) in 2011, according to the European Centre for Disease Prevention and Control and the World Health Organization Regional Office for Europe. As concluded in the 2011 European HIV/AIDS surveillance report published by these groups: “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 focused on developing superior diagnostics to facilitate rapid detection and early treatment of HIV and other infectious diseases. This recently granted CE Mark gives the company an opportunity to bring these key diagnostics to the European market, which is an area that continues to see an increase in HIV among certain significant populations. Chembio will continue working with regulators in Europe to obtain CE Marks for several other diagnostic products this year, as well, including the HIV 1/2 STAT-PAK test, the DPP HIV 1/2 Oral Fluid test and the DPP Syphilis test.
For more information, visit www.chembio.com
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