Regulatory Focus™ > News Articles > OTC Test for HIV Approved by FDA Advisory Panel

OTC Test for HIV Approved by FDA Advisory Panel

Posted 16 May 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration's (FDA) Blood Products Advisory Committee voted 17-0 on 15 May to recommend OraSure's In-Home OraQuick HIV Test, the first such product to be approved for over-the-counter (OTC) testing for the Human Immunodeficiency Virus (HIV).

According to clinical studies, the device is 99.98% effective at determining whether or not a person is infected with the HIV virus.

The product had been faced with some early concerns about the accuracy of the test, and whether false positives or false negatives from the test might represent a public health concern.

Those concerns seemed to be assuaged-or simply outweighed-by the product's purported health benefits. A review found widespread use of the test could prevent more than 4,000 cases of HIV transmission each year, reported Med Page Today. The panelists also indicated they believed any false negatives-a situation in which the test indicates an HIV-negative status, when in actuality, the virus is present-would likely be in persons who would otherwise not have been tested anyway.

To minimize the number of false negatives, panelists said they expected OraQuick to be paired with language indicating the device is only effective three months after potential exposure to HIV. OraSure also said it plans to maintain a 24/7 hotline for consumers to call and obtain information regarding the test.

The device is quite similar to a one already familiar to many consumers, reports CNN. "Much like a pregnancy test, one line shows up if the test is negative, two lines means it's positive."

The product now moves to FDA for final consideration and likely-though not certain-aproval.

Read more:

Med Page Today - FDA Panel Says Yes to Home HIV Test

CNN - FDA panel recommends approving home HIV test

Salon - FDA panel backs first rapid, take home HIV test

Regulatory Focus newsletters

All the biggest regulatory news and happenings.