Genetic Systems Corp. said Thursday that it has received Foodand Drug Administration approval to sell the first combinationtest kit for both HIV-1 and HIV-2.
The enzyme immunoassay (ELISA) test, which incorporatesinactivated whole virus of both AIDS viruses, detects withinfour hours circulating antibodies to the viruses in humanserum or plasma. Pricing information was not available.
Although the FDA hasn't required HIV-2 antibody testing, FDACommissioner David Kessler said the test may "encourage morewidespread testing for this virus."
There are 42 identified cases of HIV-2 in North America,according to Genetic Systems, which since 1990 has sold theonly licensed HIV-2 test.
Genetic Systems of Seattle has an exclusive North Americanlicense for diagnostic application of Institut Pasteur's U.S.patent No. 4,839,288 claiming HIV-2 and its purifiedcomponents. Genetic Systems is a division of SanofiDiagnostics Pasteur of France.
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