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FDA panel recommends approving home HIV test
May 15th, 2012
07:48 PM ET

FDA panel recommends approving home HIV test

Consumers may soon be able to test themselves for HIV and quickly learn the results in the privacy of their own homes following a unanimous approval recommendation from a Food and Drug Administration advisory committee on Tuesday.

The panel said the OraQuick In-Home HIV Test should be made available over-the-counter (OTC) saying the test is safe and effective and that the benefits far outweigh the potential risks.

If approved by the FDA, the test will be the first OTC test to be marketed for HIV or any infectious disease.  FDA advisory committee recommendations are not binding, but they are generally followed.

An estimated 1.2 million Americans are living with HIV, according to the Centers For Disease Control and Prevention.  One in five of those are unaware of their HIV status.  And about 50,000 new cases of HIV are reported each year.

OraSure Technologies, Inc., the manufacturer of this new test, also makes the already approved OraQuick ADVANCE Rapid HIV-1/2 Antibody Test.

That test can only be used in a clinical setting and results are provided in 20 minutes.  The In-home test is a modified version where the individual swabs the upper and lower gums with a test pad device.  That device is then inserted into a vial of solution. Much like a pregnancy test, one line shows up if the test is negative, two lines means it's  positive.

The kit includes step-by-step instructions on when to test, how to set-up and administer the test, and how to interpret the results. The company also provides information on how to follow-up on the results through OraQuick's Answer Center for support and local medical referral is also provided. The center is staffed 24 hours a day, 7 days a week.

"The test is designed to be comprehensive across a broad range of literacy levels," said Stephen Lee, OraSure's executive vice president and chief science officer. "It enables use in a variety of testing environments."

According to Lee the test has a high degree of accuracy and 93% sensitivity.  In clinical studies the test proved 99.98% effective in determining who did not have the virus.  Panelists were concerned about making sure there was comprehensive language in the kit regarding a testing window. Specifically, you must wait 3 months between high risk behaviors before testing.  Another major concern was the risk of false positives and false negatives.

But for the 25 or so health care professional and HIV/AIDS advocates that addressed the panel, imploring the committee to vote for approval, those risks did not outweigh the opportunity to expand public access to testing and reduce the number of infections by making sure people know their HIV status.  That a test could be done in the privacy of their own homes was seen as an added bonus - and a way to address the stigma surrounding HIV.  Nobody requested that the test should not be approved.

"We need to do whatever we need to move the needle of the number of people who don't know their status," said Whitney Cordova of the AIDS Healthcare Foundation. "This test helps do that. The perfect cannot be the enemy of the good."

"It is clear OTC is not the right way to be tested for everyone," said Tom Donohue, Jr., founder of Who's Positive. "OTC is another tool.  OTC has the potential to reach a far greater number of individuals who want to know their HIV status on their own terms.  It's time for everyone to know their HIV status. It's time to give people tools without barriers to know their status."

If the OraQuick In-Home HIV Test gets final FDA approval, hopes are high that this new tool will be instrumental in helping to reduce infection rates in the U.S. and globally.

There are "1.2 million people living with AIDS in the U.S. - and 20% don't know it. This is a ticking time bomb," said Frank Oldham, president and CEO of the National Association of People With AIDS. "We need more weapons to reduce HIV infections and we are morally obligated to bring this test to market and reduce the spread HIV."

Cornelius Baker, technical adviser for the FHI 360 Center on AIDS & Community Health, underscored the value of testing at home with rapid results.

"This is especially important for those who will not seek testing in a public place or who need the convenience because of geography or time to test more frequently with this new method," Baker said. "If we are to win the battle against the HIV epidemic, we need to employ multiple strategies. While [this is] not a product that every person will use or need, this in-home test is one more contribution to helping every American become part of ending AIDS in the United States."

FDA presenters clearly felt the test had merit.

"Greater access to testing will potentially lead to more people knowing their HIV status." said Dr. Elliot Cowan, who spoke on behalf of the FDA. "It appears there is a benefit in increasing the number of HIV positive people who know their status. There is public health impact and personal health impact."

OraSure Executives seemed confident of approval calling it a momentous day for public health. "We plan to work with the FDA over the coming months to refine product label enhancements," said Douglas Michels, the company's president and CEO. "And as quickly as we can get that done will determine how quickly we can get the product to retailers."

Michels says they have not yet finalized their pricing, but will sell the test to retailers at a discount and ultimately retailers will set the price.


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