FDA Approves OraSure's Over-The-Counter Home HIV Test

07/03/2012| 03:09pm US/Eastern

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--FDA approves first HIV test to be sold in retail stores

--Test will be available in October

--Home test appears to be not as accurate as tests by health professionals

(Adds company comments on test availability, pricing, in the third and fourth paragraphs.)

 
   By Jennifer Corbett Dooren 
 

WASHINGTON--The Food and Drug Administration Tuesday approved a home HIV test that will be sold in retail stores so people wouldn't have to go to a health facility to learn if they have the virus.

The test, made by OraSure Technologies Inc. (>> OraSure Technologies, Inc.), has been available to health-care professionals. The test, called the OraQuick In-Home HIV test, uses a mouth swab to collect saliva. The swab is then inserted into a test tube where results are made available within a 20-to-40 minute time frame.

Company officials said the test will be available in October and sold at more than 30,000 retailers such as Wal-Mart Stores Inc. (>> Wal-Mart Stores, Inc.) and large grocery and drug-store chains including CVS Caremark Corp. (>> CVS Caremark Corporation), Rite Aid Corp. (>> Rite Aid Corporation) and Walgreen Co. (>> Walgreen Company). The test will also be sold online.

OraSure said a price hasn't been established but it will be slightly higher than the $17.50 currently paid by health-care professionals, to fund additional labeling costs and a customer-support center.

The FDA said a positive result needs to be confirmed with a follow-up test in a health-care facility. The agency also said negative readings don't necessarily mean people aren't infected with HIV because the test might not be able to pick up infections within three months before testing.

Still, the agency said the test has the potential to identify large numbers of previously undetected HIV infections, especially if used by people unlikely to use standard screening methods.

About 1.2 million people in the U.S. are infected with HIV, and about 50,000 infections are diagnosed each year, a level that has been stable for a decade. Federal health officials have estimated that 20% of people with HIV don't realize they are infected and risk spreading the virus, which causes AIDS.

"Knowing your status is an important factor in the effort to prevent the spread of HIV," said Dr. Karen Midthun, director of FDA's Center for Biologics Evaluation and Research. "The availability of a home-use HIV test kit provides another option for individuals to get tested so that they can seek medical care, if appropriate."

However, there is one concern about the home test: Clinical testing has showed it doesn't appear to be as accurate as tests conducted by health professionals.

One measure of the test's accuracy in the home setting showed it had a sensitivity rate of 92%. The FDA said this means there would be one false negative test result for every 12 tests taken in HIV-infected individuals.

The FDA said one false positive result would be expected out of every 5,000 test results taken by uninfected individuals.

Write to Jennifer Corbett Dooren at jennifer.corbett@dowjones.com.

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