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.

soundoff (393 Responses)
  1. pimpson

    Now gays don't have to wait in line!

    May 15, 2012 at 22:37 | Report abuse | Reply
    • justinstl

      You are sick minded and obviously unaware that the Hiv infection rates are higher in the heterosexual community thab in the gay community.You must live under a rock to still think that Hiv/aids is/was a gay medical condition(not really classified as a disease anymore). You still have a lot to learn about it. There are far worse diseases and medical conditions out there to worry about than HIV.

      May 16, 2012 at 00:59 | Report abuse |
    • justinstl

      You are probably one of those people who think HIV is a wrath of God thing or a someone had sex with monkey thing. Keep on believing that BS if you want . The truth is ...HIV was made by accident by the W.H.O. who was trying to genetically alter the immune systems of people in famine stricken parts of Africa to boost their immune systems to make them less susceptible to disease and sickness.

      May 16, 2012 at 01:11 | Report abuse |
    • nurse

      YOU ARE ONE OF THE WORST KIND OF PEOPLE. HOW DARE YOU! Yes gays and lesbians suffer but so do straight people. I am a nurse that takes care of hiv patients. and each and every one of mine is straight. if your parents werent related you might be able to understand the REAL way things are.

      May 16, 2012 at 05:12 | Report abuse |
    • Mike

      It started with gays. In the San Francisco area. Reagan didn't have the guts to quarantine them. Now, it has spread to the rest of society. But still it's mostly an STD. Points to an immoral, loose society.

      May 16, 2012 at 07:15 | Report abuse |
    • Rebecca

      I'm not digging this idea AT ALL! How is the CDC supposed to track those infected if people can now take an HIV test at home?

      May 16, 2012 at 07:39 | Report abuse |
    • corona76

      That's right, pimpson; you'll be able to test yourself at home. I can only imagine your excitement of finally being able to pass a test.

      May 16, 2012 at 14:03 | Report abuse |
    • Manny

      People, please don't feed the Trolls with comments!

      May 16, 2012 at 15:37 | Report abuse |
    • MashaSobaka

      HIV rates are highest in heterosexual minority communities, you moron.

      May 17, 2012 at 00:28 | Report abuse |
    • Todd in DC

      So Mike, are you suggesting that smokers deserve cancer, obese people deserve heart attacks and strokes, and women deserve poverty if they have children out of wedlock? Or does your morality only affect people you don't knowingly associate with?

      May 17, 2012 at 08:47 | Report abuse |
  2. Visit_AesopsRetreat Dot Com


    The Obama agents, through the DHS and other assorted colluders, are plotting a major ‘Reichstag’ event to generate racial riots and produce the justification for martial law, delaying the November 2012 elections, possibly indefinitely, a DHS whistleblower informed the Canada Free Press on Tuesday.
    The ‘Reichstag Event’ would take the form of a staged assassination attempt against Barack Obama, “carefully choreographed” and manufactured by Obama operatives. It would subsequently be blamed on “white supremacists” and used to enrage the black community to rioting and looting, the DHS source warned.

    May 15, 2012 at 22:37 | Report abuse | Reply
    • ArtInChicago

      Just let me know where you will be so I can slap you.

      May 16, 2012 at 00:43 | Report abuse |
    • willy

      WHOA!! That sounds awesome man! It would be even better if they could couple that crazy staged assassination story of yours with the return of Tupac.

      May 16, 2012 at 15:37 | Report abuse |
    • Todd in DC

      Dude, PCP and Tina should never be combined.

      May 17, 2012 at 08:48 | Report abuse |
  3. it did not take this long to formulate a home test

    y would the governent after all these years finally come up with a test that will identify a aids gene? I THINK THIS IS TO LABLE AIDS PEOPLE TO PUT IN THE CAMPS THAT THEY HAVE SPREAD THROUGHOUT THE WORLD

    May 15, 2012 at 22:37 | Report abuse | Reply
    • Krista

      They "did not take this long to identify they AIDS gene." It is identifying the antibody that would be present in a patients serum if they are infected with HIV. you can go to a doctor to get tested, this is just an OTC option like a pregnancy test.

      May 15, 2012 at 22:57 | Report abuse |
    • Holly

      There is no aids gene, it's a virus.

      May 16, 2012 at 01:41 | Report abuse |
    • D

      @Holly. HIV is a retrovirus that has its own genes! These genes integrate into the host (human) genome. However this test does not test for the genes, it tests for human antibodies to the virus.

      May 16, 2012 at 13:10 | Report abuse |
    • Todd in DC

      The issue isn't how long it took to create the test, but the ramifications of someone finding out they are HIV positive alone without counsel right there.

      The only reason why the test is available now is that HIV is no longer a death sentence, or even chronically dibilitating, if you have access to the HAART medicines.

      May 17, 2012 at 09:10 | Report abuse |
  4. Krista

    Reblogged this on MedLabMaven and commented:
    New upcoming OTC HIV test. May help get people who think they might have HIV exposure to get tested and remove of the stigma.

    May 15, 2012 at 22:58 | Report abuse | Reply
    • stdpalcom

      maybe this news is informative for my HIV friends on hivlover.com.

      May 17, 2012 at 23:06 | Report abuse |
  5. Jay

    So many lucky dudes can bang chicks without condoms. Just break out the test and then penetrate

    May 15, 2012 at 23:09 | Report abuse | Reply
    • not really

      Please keep in mind that this test is looking for antibodies. These antibodies can take up to three months (in 97% of HIV+ patients) to be detected by such tests. Assuming someone was exposed to HIV last week, that test will be negative. Having a negative test within the first three months can't say anything. This is actually a risk of having in-home testing like this. Someone, who is in fact hiv+, could get tested within the window period and that test might tell them they are negative and go ahead and have sex unprotected and spread the virus. However, the benefit of reducing barriers to patients to get tested outweighs that risk.

      May 16, 2012 at 02:02 | Report abuse |
  6. Diane

    Good, hopefully they can also make progress on developing OTC tests for other STIs as well. You should be able to test in the privacy of your own home without a doctor looking over your shoulder and writing everything down.

    May 16, 2012 at 01:01 | Report abuse | Reply
  7. Diane

    Good, hopefully they can also make progress on developing OTC tests for other STDs as well. You should be able to test in the privacy of your own home without a doctor looking over your shoulder and writing everything down.

    May 16, 2012 at 01:02 | Report abuse | Reply
    • Diane

      Sorry for double post, didn't think first one went through.

      May 16, 2012 at 01:03 | Report abuse |
  8. justinstl

    The test is to find HIV antibodies ...not Aids. Just because one is hiv+ does not mean that they have or even ever will get Aids. There still is no proof that the hiv virus even causes aids! Yes in nearly all of Aids cases hiv is present in the blood but they still have not isolated what causes it ...thus they can not definativle prove that hiv causes aids.

    May 16, 2012 at 01:04 | Report abuse | Reply
    • Holly

      What world are you living in..... hiv causes aids.

      May 16, 2012 at 01:42 | Report abuse |
    • Todd in DC

      AIDS is the condition where the T-4 cells drops to less than 200 per ml of blood. My t-cell count was 280 before I started going on meds. I had minor symptoms like chronic diarrhea. This after I was infected for less than 2 months. After going on meds, my t-cell count jumped to 450. Now it is around 750 (4 years later).

      HIV causes AIDS. Ignorance perpetuates it.

      May 17, 2012 at 08:52 | Report abuse |
    • Marly Mar

      I'm glad to see SOMEONE speaking truthfully on this thread. Their is NO test for HIV!!! These tests come up reactive for ANYTHING AND EVERYTHING EXCEPT HIV!! Research what is happening in the courts to learn the truth!

      May 17, 2012 at 11:08 | Report abuse |
  9. Emigdio Alvarez

    why not just focus more on a cure rather than on enlargement pills? Why bother fixing the gun if you can't shoot whoever you want?

    May 16, 2012 at 01:06 | Report abuse | Reply
    • MashaSobaka

      Preventing the spread of the infection is also important, actually.

      May 17, 2012 at 00:30 | Report abuse |
    • Todd in DC

      The existing treatments prevent transmission. Truvada prevents infection. It isn't a cure or a vaccine, but it is a good partial solution.

      May 17, 2012 at 08:53 | Report abuse |
  10. justinstl

    otc test will probably cost an arm and a leg enabling some fat cat to get richer off of scared people! In that case it would be better to take the test at the health department or at night clubs that offer the test for FREE!

    May 16, 2012 at 01:19 | Report abuse | Reply
  11. justinstl

    The hiv stigma and fear will never go away. Sad but true that people will always be ignorant on this subject. There are far worse things to worry about healthwise than hiv. Personally I would rather hav hiv than herpes or HPV ANY DAY!

    May 16, 2012 at 01:24 | Report abuse | Reply
    • Krista

      Are you serious? You'd rather have HIV?.....

      May 16, 2012 at 01:45 | Report abuse |
    • Holly

      You're obviously a troll, you would not rather have hiv.

      May 16, 2012 at 01:46 | Report abuse |
    • Todd in DC

      Neither HPV nor herpes are life threatening. HIV is treatable, but only if you live in a country that has access to the proper drugs, and even then, only if you have adequate insurance or enough money to afford them.

      HIV kills horribly if you don't take the treatments.

      May 17, 2012 at 08:55 | Report abuse |
  12. Dave

    Only allowed in a clinical setting? The average worker doesn't have time or insurance for that.

    May 16, 2012 at 01:36 | Report abuse | Reply
    • HIV Testing and Prevention Counselor

      The average worker doesn't need to afford the test in a clinical setting. Community based organizations aimed at education and prevention regarding HIV do this testing for FREE!!! Further, it is done on either a confidential or anonymous basis in a setting the provides immediate support, referral, comfirmatory testing, and crisis as well as long term counseling. ALL FOR FREE!

      May 16, 2012 at 13:29 | Report abuse |
    • Diane

      It can never be as anonymous or confidential as testing yourself though.

      May 17, 2012 at 01:03 | Report abuse |
  13. Holly

    Umm, you can already do this. I bought one for myself just to be safe. It was 30 bucks, arrived very quickly and confidentially, and worked perfectly. So what's the point of this article?

    May 16, 2012 at 01:39 | Report abuse | Reply
    • MashaSobaka

      The point of this article is to let people like you know that you were probably scammed. I really hope you got a second opinion.

      May 17, 2012 at 00:31 | Report abuse |
    • Todd in DC

      Actually Holly, the only existing take home test was one where you sent a blood sample into a lab. This one tells you if you have HIV antibodies in your own home.

      May 17, 2012 at 08:57 | Report abuse |
  14. checkyofacts

    I would worry about giving someone the tools to find out that they have a deadly disease alone in their home with no one to comfort them or talk them out of doing something to hurt themselves. Add to that the possibility of a false positive and you have the potential for tragedy.

    May 16, 2012 at 04:09 | Report abuse | Reply
    • D

      Do you even know how to read? All of this is described FULLY in the article.

      May 16, 2012 at 13:16 | Report abuse |
    • HIV Testing and Prevention Counselor

      THANK YOU!!!! It does not matter how prepared an individual thinks they are in terms of recieving a positive HIV result. I am here to inform you all that when someon recieves a posotive result, even if they are expecting to test positive, the presence of tangible evidence of such a diagnosis remains a shocking and life changing event even for the most prepared. As an RN, a Master's prepared Mental Health counselor, and an individual that has experienced this phemonmena up close and personal, it is without doubt my opinion that allowing people to test themselves at home without immediate support and access to resources at the time of the test result is like asking for a disaster. It makes me wonder if they will include directions for how to effeectively complete suicide will also be a part of the directional package insert. In my community alone there have been two recent suicides among those considered to be at high risk for HIV. Is this the new direction we are taking in terms of eliminating HIV? Allowing people the opprtunity to reduce transmission through the act of suicide.

      May 16, 2012 at 13:21 | Report abuse |
  15. Big Will

    my only concern is that they have something included for people that test positive and where to go for additional testing and counseling. I once got a false positive in college while donating blodd. It was a horrible feeling. Even though I got retested and cleared, I have never donated blood again for the last 15 years because of that scare.

    May 16, 2012 at 08:30 | Report abuse | Reply
    • D

      Read the article.

      May 16, 2012 at 13:17 | Report abuse |
  16. Valcoor the Dragon Slayer

    Everyone knows that God invented HIV to rid the world of the gay population lol

    May 16, 2012 at 12:10 | Report abuse | Reply
    • D

      Everyone is susceptible. In Africa, it is mostly straights who get the disease.

      May 16, 2012 at 13:18 | Report abuse |
    • HIV Testing and Prevention Counselor

      LOL? I really hope that your comment was ment as a sick joke. However, if not, I would like to commend you on your stellar display of absolute ignorance. The only disease more deadly than HIV/AIDS is ignorance.

      May 16, 2012 at 13:25 | Report abuse |
  17. Alan S

    The response by Nurse is puzzling. She wrote that Pimpson is one of the worst kinds of people there are. Really? Worse than mass murderers? Worse than oppressive dictators? Worse than baby-killers? Worse than people who knowingly expose their partners to HIV?

    Nurse's statement that Pimpson's parents were related - presumably to each other - was childish, and says far more about her than about Pimpson.

    Studies reported in the British Medical Journal and Science Daily reported in 2007 that in 2005 more than half of new HIV infections were of gay men. There is no reason to believe that other years were different. HIV does disproportionately infect gay men. Pimpson's comment is tacky and insensitive, but no worse than that. My Heavens, Nurse: relax.

    May 16, 2012 at 16:18 | Report abuse | Reply
    • MashaSobaka

      Gay men are not the largest group of carriers. African-American women passed them long ago. Now heterosexual African-American men are catching up to African-American women. Please try educating yourself. Numbers change rapidly.

      May 17, 2012 at 00:33 | Report abuse |
  18. jaxsat

    Not sure this a good idea...HIV cases need to be tracked...you would think that after 30 years, and billions and billions of dollars we would have a cure by now, and not just a home test...it is the most political disease in history.

    May 16, 2012 at 18:20 | Report abuse | Reply
    • MashaSobaka

      They're working on an immunization. Which is kind of a miracle considering how many people still believe that this is a "gay disease" that "the gays bring on themselves."

      May 17, 2012 at 00:34 | Report abuse |
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    May 17, 2012 at 02:47 | Report abuse | Reply
  20. Marly Mar

    These tests have no standard and are bogus. They do not test for a specific particle. Wake up people!!

    May 17, 2012 at 11:03 | Report abuse | Reply
  21. Marly Mar

    To date there IS NO TEST to TEST for HIV! These tests come up reactive for anything an everything EXCEPT "HIV" Do your research!! Ask to read the disclaimers of these bogus tests to learn the truth!! Research what is happening in the courts where they are setting precedent and chipping away at the "hiv" testing fraud and lies!

    May 17, 2012 at 11:10 | Report abuse | Reply
  22. Marly Mar

    Learn about the fraud of testing!!

    May 17, 2012 at 11:11 | Report abuse | Reply
    • Hamzah

      The date of the last unprotected seuxal encounter starts the 3 month period. Unprotected sex is a risk factor for acquiring HIV. Add multiple sex partners-another risk factor. I'll set this up with only seuxal transmission as a risk factor although of course there's swapping blood through injecting drugs and mother to baby. Scenario: If you had a negative HIV result this week, to be certain of the result, 1. you should either abstain from sex or practice safer sex by using condoms with every seuxal encounter. 2. Re-test in 3 months-the Western blot and Elisa tests identify the HIV antibody not the virus itself (both tests are done routinely on each blood sample as a confirmation) The body develops these antibodies in approximately 3-6 months after being infected with HIV. 3. Continue the abstinence or safer sex and re-test again in 3 months. 4. Practice abstinence until you are in a monogomous relationship or safer sex thereafter. There is no such thing as safe sex. SAFER sex is protecting yourself by using a barrier-the condom. Abstinence is the only 100% effective means of avoiding HIV via seuxal transmission.

      October 11, 2012 at 16:17 | Report abuse |
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