OraSure Acquires License To Use Rapid Test To Detect HIV-2 in Oral Samples

Bethlehem, Pa.-based OraSure Technologies on Monday announced it has acquired the rights to use its OraQuick Rapid HIV-1/2 Test to detect HIV-2 in oral samples, the Allentown Morning Call reports (Kennedy, Allentown Morning Call, 6/22). Although FDA already has approved the test to detect HIV-1 and HIV-2 in blood samples, it has approved only the oral version of the test for HIV-1. The oral test, which produces results in 20 minutes, requires health care workers to wipe a treated swab along the gums of a patient's mouth and place the swab into the testing liquid. If one line appears on the swab, the person is 99.8% likely to be HIV-negative. However, if two lines appear on the swab, the person is 99.3% likely to be HIV-positive, although a laboratory test is required to confirm the result (Kaiser Daily HIV/AIDS Report, 3/29). The new licensing agreement with Bio-Rad Laboratories, which owns patents on HIV-2, allows OraSure to market the oral test for use in detecting HIV-2, which has become increasingly common in Africa. Bio-Rad acquired the HIV-2 patent from Institut Pasteur, which discovered the strain of the virus. Under international law, the entity that discovers a virus has the right to patent it and collect royalties from groups that produce related products, according to the Morning Call. OraSure had been negotiating with the company for more than one year to obtain rights to market its test for use with HIV-2. Bio-Rad said it had delayed closing the deal because it had to seek consent from the other companies to which it had licensed the HIV-2 patent, OraSure CFO Ron Spair said. "Our goal has always been to create the most versatile and comprehensive point-of-care rapid HIV test in the world," OraSure President and CEO Mike Gausling said, adding, "We believe that a combination OraQuick rapid antibody test for both HIV-1 and HIV-2 will be a critical tool in fighting the pandemic" (Allentown Morning Call, 6/22).