Jul 03

FDA Approves First At-Home HIV Test

On July 3, 2012, the U.S. Food and Drug Administration (“FDA”) approved the first over-the-counter (“OTC”) at-home test kit used to detect human immunodeficiency virus (“HIV”). According to the FDA’s announcement, the OraQuick In-Home HIV Test allows the user to collect an oral fluid sample by first swabbing the gums. Thereafter, the sample is placed in a vial where the results will be displayed within 20 to 40 minutes. Of course, like most other at-home tests, the FDA warns that the results of the test are not definitive in nature and that additional testing in a clinical setting should be used to confirm the results.

The approval of an at-home HIV test kit marks a milestone with respect to HIV testing. Before today, the FDA has only approved HIV tests to be used by trained practitioners in medical settings. In fact, OraSure Technologies, Inc., the manufacturer of the OraQuick In-Home HIV Test, was first approved in 2004 for use in clinical settings by trained professionals. Devices associated with blood donor testing, like the one FDA test kit here, must secure FDA authorization through the Premarket Approval (“PMA”) process. Through this process, the FDA approves products for only those specific conditions and/or uses listed in the product labeling. Thus, while similar tests have been available on the market, this is the first time these tests may be marketed and sold to the public for use in the home.

For more information about the PMA process or other regulatory issues, please feel contact us here.

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