Home » Breaking News, Health » OraQuick H.I.V. Home Test Gets FDA Approval

The U.S. Food and Drug Administration has  approved an in-home rapid HIV test made by OraSure Technologies Inc.

The OraQuick In-Home HIV Test uses an oral swab and provides results in as little as 20 minutes. It is identical to the company’s OraQuick Advance Rapid HIV-1/2 Antibody Test — used by physicians and other professionals for the last 10 years — with new packaging and labeling, and the addition of consumer support services, including a 24/7 call center.

The agency does not intend for the home test to replace medical testing, but instead to provide another way for people to find out their H.I.V. status, said Dr. Karen Midthun, director of the F.D.A.’s Center for Biologics Evaluation and Research.

OraSure believes the market for an over-the-counter HIV test will exceed $500 million. OraSure on Tuesday closed up 60 cents, or 5.22 percent, at $12.10 a share on the Nasdaq exchange. The stock has surged 18 percent in the last five days. As business continues to expand, the company projects it will add more jobs to the Lehigh Valley region.