Chembio Diagnostics Receives FDA "Approvable" Letter for Rapid HIV Tests

FDA has issued an "approvable" letter to Medford, N.Y.-based Chembio Diagnostics for its rapid HIV tests SURE CHECK HIV 1/2 and HIV 1/2 STAT-PAK as long as certain conditions are met, the company announced Wednesday, the United Press International reports (United Press International, 4/19). The products detect HIV-1 and HIV-2 antibodies and give results in about 15 minutes. According to the letter, the agency must review the package inserts for each test before granting final approval, Long Island Newsday reports. If the products are approved, Chembio will be allowed to sell the tests to clinical laboratories and hospitals nationwide (Kerr, Long Island Newsday, 4/19). Javan Esfandiari, Chembio's vice president of research and development, said, "Rapid tests allow greater access to testing, which results in more people being diagnosed earlier, when treatment is most effective" (Chembio release, 4/19).

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