FDA approves first HIV test for home use

The at-home HIV test from Bethlehem-based OraSure, will requires only a swab of saliva. The market for the test, likely available in Oct., could exceed $500 million.
The at-home HIV test from Bethlehem-based OraSure, will requires only a swab of saliva. The market for the test, likely available in Oct., could exceed $500 million.
Posted: July 05, 2012

The U.S. Food and Drug Administration on Tuesday approved an in-home rapid HIV test made by OraSure Technologies Inc., based in Bethlehem, Pa., for over-the-counter sales. This marks the first FDA approval for a rapid, over-the-counter diagnostic test that screens for infectious disease.

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.

Douglas A. Michels, president and CEO of OraSure, said the product was a "critical new tool in the fight against HIV and AIDS" and would be available at more than 30,000 major retailers, as well as online, around early October.

While a suggested retail price will surface closer to the launch date, the professional version currently sells for $17.50 per test. Michels said consumers should expect a higher price, given the extra costs needed to prepare the test for home purchase and use. But ultimately, he noted, prices will be set by retailers.

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.

As with any other at-home test, it will be "very important that consumers read and follow directions," Michels said. For instance, there is a three-month period after infection when the immune system does not produce enough antibodies to be detected by the test. A test during that three-month window may show a false negative. Also, a positive result is only "preliminary" and needs to be confirmed by a health-care professional.

Having an HIV test that can be taken in the privacy of the home is a "positive step forward," said Jane Shull, executive director of AIDS services organization Philadelphia Fight. It may help those who would not ordinarily go to a doctor or clinic for testing, either out of fear of being seen or simply not having convenient access to one. "It's all about giving people options," said Shull.

Georgett Watson, chief of program operations at the South Jersey AIDS Alliance, said that, with AIDS now being seen as a "manageable disease," people were more willing to be tested. "Today, even though there's a stigma," she said, "people do know the sooner you get into treatment, the longer you can prolong your life."

Shull sees a parallel between this type of at-home HIV testing and over-the-counter pregnancy tests. When at-home pregnancy tests "first came on the market, there were lots of questions, but now it is just the standard."

Meeri Kim can be reached at mkim@phillynews.com.

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