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Reuters
WASHINGTON - A U.S. Food and Drug Administration panel of outside experts concluded that OraSure Technologies Inc's over-the-counter, in-home HIV test is reasonably safe and effective for determining whether someone has the AIDS virus.
The 17-member FDA advisory committee voted unanimously that the drug's ability to prevent new HIV infections and provide HIV-positive people with access to medical care and social services outweighed the risks of false results.
Tuesday's recommendations will now be considered by agency regulators as they determine whether the product, known as the OraQuick In-Home HIV Test, should be approved as the first-ever over-the-counter, completely in-home HIV test.
Advocates say the in-home test would provide a new and potentially powerful strategy for attacking an U.S. HIV epidemic that has infected nearly 1.2 million people and increases by 50,000 new cases each year.
Trading in OraSure's shares was halted for the FDA meeting after closing on Monday at $9.10.
The company said it would expect the product to retail for less than $60, if approved and marketed over the next the several months.
Panel members urged OraSure to undertake post-marketing studies to ensure that the test is available to under-served populations in a manner that would link those who use the kit to the healthcare services including confirmatory tests at professional settings.
A home version of the professionally administered OraQuick Advance test, the new product is an oral swab rapid test that produces results within 20 minutes. The test should not be taken until 90 days after an individual last had an risky behavior.
FDA officials said the OraQuick In-Home test showed a high degree of effectiveness in detecting HIV infection. But some research data suggested the test lacked sufficient sensitivity to avoid false negative results.
False negatives are of particular concern because they could lead HIV-positive individuals to take fewer precautions, raising the danger that they will engage in unprotected sex.
Some panel members argued for strongly worded labeling about false results and procedures to link those who telephone a company hotline with questions with healthcare professionals.
U.S. health officials told the panel that home-testing could help get needed healthcare to HIV-positive individuals earlier. At present, only 62 percent of those with HIV are linked to the healthcare services and just 28 percent have access to drugs capable of suppressing the infection.
The panel heard overwhelmingly supportive public testimony from more than two-dozen witnesses including HIV activists, black community representatives and public health experts, some of whom received money and other assistance from OraSure.
The witnesses urged the panel to back the test as a means of eliminating HIV's public stigma, a main barrier to testing, by making the home test just another item that can be purchased at a local pharmacy along with aspirin or condoms.
Whitney Engeran of the AIDS Healthcare Foundation, a Los Angeles-based group that provides care for nearly 170,000 HIV patients, said the potential ability to break down the stigma outweighed the product's shortcomings. "The perfect cannot be the enemy of the good," he said.
One witness, who represented healthcare providers, urged the FDA to withhold approval until further study can raise the test's accuracy to a level more in line with those administered in clinics and other professional settings.
Last week, another FDA panel recommended regulatory approval for Gilead Sciences Inc's HIV drug, Truvada, as the first pill treatment for protecting uninfected individuals.
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Just make sure the packets include a link to your local Therapist, just in case.
I remember the first (and only) time I saw a doctor for an HIV test. Being Black, male, and in my early 20's, the default assumption was that I had already been infected even before the test was administered. The staff went to great lengths to prepare me psychologically for the worst case scenario. Inside I was just laughing my head off since no one else in the clinic realized that I haven't had sex more than five times in my entire life, that I was wearing condoms in three out of the five err... "acts," and that I didn't have any strong reasons to suspect the now ex-gf was infected. I was just some paranoid guy reeling from guilt over not having used a condom, but someone apparently forgot to remind me I was Black until I walked into the clinic, stated my reason for being there, and saw the funny look on everybody's face.
Baldman, Sadly not everyone at every clinic is the most professional and many make fast but inaccurate assumptions. I am glad that they did work to prepare you though, as many times people who are at clinics requesting testing are there because they have a strong suspicion that they are positive and the news can be devastating.
I agree that the packages should include contact information to local therapists. It actually would be a good idea that such information be required to be discreetly available when the tests are purchased.
For those who take at home HIV tests, there are MANY good HIV service organizations available that will offer free or reduced cost counseling and have people available to answer questions. The tests are not 100% accurate, so follow up if you are concerned is important. There are also state psychological associations you can find easily with google. These associations have search links to find psychologists who work with HIV positive (or even negative but just worried) patients and their families. HIV is no longer a death sentence and there is help available!
Agreed, local contact information to the health district, therapists or HIV coordinator would be a great idea. This is my opinion, but I think the greatest allure of these tests is for people who are really paranoid about someone knowing or suspecting they are HIV positive.
I know our local HIV counselor. You can a free and accurate HIV test, probably multiple a year, no questions asked as to why and the results are confidential to you. For me I'd just use them, but I have yet to engage in any risky behavior to open myself up to HIV, so I wouldn't be all that worried.
The 60 dollar price tage would be too high for some people or families to afford. Would it become subsidized? Would insurance over a at home test?
It'll be interesting to see how it all pans out. I still think it's a good thing, I just feel that some people are too afraid to take a test and find out they are HIV positive.
Inadaze, if someone can't afford an at-home test there are ways to get tested for free. Health departments will perform such a test. When I attended college they performed free tests for students and the community. A quick search will find many ways to get tested for free, though one must sacrifice the privacy of their own home to do so.
If you can already get free and accurate HIV tests done, there is NO need for a test such as this one - just one more pharmaceutical company looking at big time profits off the government. Go donate blood, I bet you get a free HIV test there.....
I agree that free tests are available, BUT many for various reasons (cheating spouses, cheated on spouses, those terrified that someone would maybe possibly find out/see them there, etc) would never go to a place to get one. My greatest concern is that someone gets a positive result and feels that they have no options for the future.
This will fill a need, but it should be done with significant care and caution.
There is a negative stigma surrounding HIV tests- that only homosexuals or druggies need such a test. But with heterosexual men and women becoming infected at increasing rates it is important for everyone who is sexually active without protection to get the test. However some people don't get tested because they don't want someone to think they're gay or a druggie, they're afraid the fact that they took an HIV test would get out and people might make incorrect assumptions of them.
Better a paid test than no test.
I was in the clinical trial for this, and I think it's a great tool to have! I live in a big city, and some people will travel 45+ minutes to get tested at a free clinic. This is a good alternative.
Counseling is definitely available by phone, no matter your results. They'll also talk to you about reducing your risk. By the way, any person who's had sex is at risk for HIV. :)
Make them go to the doctor.
First, where are they going to dispose these tests at, in their garbage cans for others to be exposed? Second, it was my understanding that HIV and/or Aids sometimes is not detectable for a few years. This could be a very dangerous thing!
The HIV tests I took a few years back were oral swabs (I took one every 6 months in front of a group as a way to encourage others to get tested). No blood, no risk of contamination. Please educate yourself on how these tests work and how HIV is passed.
HIV antibodies are generally detected 2-8 weeks after infection. I think you're thinking of AIDS developing months/years after infection.
once HIV is outside the body of the host, the length of the virus's life is about 15 to 20 minutes, it cannot last under the natural conditions of the enviroment unless its a perfect set inviroment, and HIV can easily be killed with soap, hot water, cleaning products, and other chemicals, so no need to worry about disposal of these tests in the trash or something
Another failure by the FDA. This test only detects positives 93% of the time. What do you think those other 7% are going to do when they think they are clean? Go out and buy condoms?
Pregnancy tests have a similar failure rate, and they are still on the market.
And I think that often people have similar reactions to 'scares' in these situations, buy protection to prevent another scare.