OraSure Wins U.S. FDA Approval for First At-Home HIV Test
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OraSure Technologies Inc. won approval for the first at-home HIV test that lets people get results without using a doctor or laboratory.
The Food and Drug Administration cleared the saliva test that offers results within 20 to 40 minutes and would be sold without a prescription, the agency said today in a statement. Sales may reach $20 million next year assuming a $40 price tag for the product from Bethlehem, Pennsylvania-based OraSure, said Caroline Corner, a senior analyst with McNicoll, Lewis & Vlak in New York, before the agency’s announcement.