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July 2012

FDA approves take home HIV test

July 5, 2012 -- The US Food and Drug Administration (FDA) has approved OraSure Technologies’ rapid test for HIV. The test was previously sold only to health care professionals to be used at facilities. With today’s decision, the test will become the first over-the-counter, self-administered HIV test that people can use at home.

The test, called OraQuick In-Home HIV Test, can provide results from a mouth swab within 20 to 40 minutes. In May, an FDA advisory panel recommended that the agency approve the test, which would allow customers to learn results from the test in the privacy of their own homes. The FDA has cautioned that a positive result does not mean than an individual is definitely HIV-positive, but rather that further medical tests should be administered. Additionally, a negative test result does not mean that an individual is definitely not infected with HIV, particularly when exposure might have occurred within the previous three months. Many people around the world are unaware of their HIV status, making prevention efforts more difficult.

“Knowing your status is an important factor in the effort to prevent the spread of HIV,” said Karen Midthun, MD, director of the 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.”

The FDA estimated the test would miss about 3,800 HIV-positive people per year, while correctly identifying 45,000 when approved. Given that the Centers for Disease Control and Prevention estimates that there are 1.2 million cases of HIV in the US alone—and that one in five HIV-positive people is unaware of his or her status—this take home test could have hugely beneficial results worldwide.

  • To read the Reuters article, click here.

  • To read the announcement from the FDA, click here.

  • To read about the FDA advisory panel, click here.

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