home
RSS
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 (378 Responses)
  1. RebfZisse

    viagra • cialis • https://rcialisgl.com/ – cialis prices nz cialis egypt

    May 4, 2021 at 15:44 | Report abuse | Reply
  2. Quilile

    cialis mental ed cialis rls cialis with drinking

    May 5, 2021 at 02:50 | Report abuse | Reply
  3. RebfZisse

    cheap cialis https://rcialisgl.com/ cialis price

    May 5, 2021 at 14:07 | Report abuse | Reply
  4. AnooEncox

    viagra chats https://llviagra.com/ cual es la mejor pastilla viagra

    May 5, 2021 at 20:19 | Report abuse | Reply
  5. BbshMile

    poppers and viagra http://loxviagra.com/ where to get viagra

    May 5, 2021 at 22:18 | Report abuse | Reply
  6. kaInsot

    cialis importado buying cialis usa cialis 5mg half life

    May 6, 2021 at 02:09 | Report abuse | Reply
  7. dapoxetine

    buy avanafil uk priligy generic

    May 6, 2021 at 11:44 | Report abuse | Reply
  8. LebnEncox

    canadian pharmacy india viagra generic canadian pharmacy Urispas

    May 6, 2021 at 12:16 | Report abuse | Reply
  9. LbsoZisse

    viagra/cialis black and gold 800 https://ucialisdas.com/ purchase cialis

    May 6, 2021 at 15:51 | Report abuse | Reply
  10. JebgEncox

    canada prescription drugs https://pharmacylo.com/ Ventolin inhalator

    May 6, 2021 at 18:41 | Report abuse | Reply
  11. LbsoZisse

    original cialis uk http://ucialisdas.com/ price of cialis

    May 7, 2021 at 22:01 | Report abuse | Reply
  12. loans_ot

    cash advances dearborn heights everest cash advance oakland park online cash advance tulsa

    May 7, 2021 at 22:35 | Report abuse | Reply
  13. LebnEncox

    Mentax https://xlnpharmacy.com/ Zebeta

    May 8, 2021 at 12:00 | Report abuse | Reply
  14. GtnbCrulk

    how to get a free trial of viagra http://jokviagra.com/ what are the side effects of viagra

    May 9, 2021 at 13:55 | Report abuse | Reply
  15. GtnbCrulk

    how much does viagra cost https://jokviagra.com/ female viagra pills

    May 9, 2021 at 15:28 | Report abuse | Reply
  16. ret_les

    We accept BitCoin – tretinoin for sale without prescription is cialis going generic

    May 9, 2021 at 22:58 | Report abuse | Reply
  17. Lakeisha Latulipe

    Have you ever heard of second life (sl for short). It is basically a online game where you can do anything you want. SL is literally my second life (pun intended lol). If you want to see more you can see these Second Life articles and blogs

    http://adolit.blogspot.com/2008/05/school-on-film-entre-les-murs.html

    May 10, 2021 at 09:08 | Report abuse | Reply
  18. JebgEncox

    best canadian online pharmacy https://pharmacylo.com/ canadian pharmacies that are legit

    May 10, 2021 at 14:27 | Report abuse | Reply
  19. BbshMile

    buy real viagra online http://loxviagra.com/ – best price on viagra 100mg otc viagra usa

    May 10, 2021 at 14:45 | Report abuse | Reply
  20. ret_les

    We accept BitCoin – isotretinoin ohne rezept cialis generika uk

    May 10, 2021 at 18:53 | Report abuse | Reply
  21. FmrfEncox

    buy cialis online in australia https://cialisee.com/ – cialis promise program black cialis mexico

    May 11, 2021 at 00:35 | Report abuse | Reply
  22. AnooEncox

    viagra jak wyglada http://llviagra.com/ come funziona viagra

    May 11, 2021 at 05:02 | Report abuse | Reply
  23. FmrfEncox

    is cialis as effective as viagra http://cialisee.com/ overnighted cialis for men

    May 11, 2021 at 11:16 | Report abuse | Reply
  24. RebfZisse

    buy cialis overnight shipping http://rcialisgl.com/ buy cialis online in australia

    May 11, 2021 at 13:57 | Report abuse | Reply
  25. Natosha Sterle

    This was great! I would like you to clean up all this spam though

    https://www.linkedin.com/in/yusuf-hanafy-82493b183

    May 11, 2021 at 21:08 | Report abuse | Reply
  26. ret_les

    We accept BitCoin – retin a shortage in canada cialis contro ipb

    May 11, 2021 at 22:09 | Report abuse | Reply
  27. RebfZisse

    cialis online paypal payment https://rcialisgl.com/ – generic cialis buy 36 hour cialis

    May 12, 2021 at 18:49 | Report abuse | Reply
  28. AnooEncox

    does viagra lose potency over time http://llviagra.com/ – si tengo 15 aГ±os puedo tomar viagra viagra side effects nausea

    May 12, 2021 at 23:35 | Report abuse | Reply
  29. loansson

    cash advance america visalia Payday Loans Probited In Nc , cash advance stevenscreek san jose ca cash advance payday loans hammond

    May 13, 2021 at 01:21 | Report abuse | Reply
  30. BbshMile

    viagra drug interactions https://loxviagra.com/ viagra at walgreens

    May 13, 2021 at 12:08 | Report abuse | Reply
  31. storno brzinol

    Do you mind if I quote a couple of your articles as long as I provide credit and sources back to your site? My blog site is in the very same niche as yours and my users would really benefit from some of the information you provide here. Please let me know if this alright with you. Appreciate it!

    http://www.stornobrzinol.com/

    May 13, 2021 at 16:14 | Report abuse | Reply
  32. LbsoZisse

    cialis online 365 pills http://ucialisdas.com/ india to buy cialis

    May 13, 2021 at 20:52 | Report abuse | Reply
  33. LebnEncox

    cheapest pharmacy for prescription drugs http://xlnpharmacy.com/ canadian pharmacy 24 com

    May 14, 2021 at 12:45 | Report abuse | Reply
  34. loansson

    cash advance usa bountiful Paydayloan Thru Money Garam , cash advanced in rome ga cash advance online palm bay

    May 14, 2021 at 18:39 | Report abuse | Reply
  35. JebgEncox

    online pharmacy without scripts http://pharmacylo.com/ Trental

    May 14, 2021 at 19:02 | Report abuse | Reply
  36. LbsoZisse

    cialis 20 mg sale https://ucialisdas.com/ viagra cialis samples

    May 15, 2021 at 01:18 | Report abuse | Reply
  37. storno brzinol

    What i don't understood is actually how you are not really much more well-liked than you may be now. You are very intelligent. You realize thus significantly relating to this subject, produced me personally consider it from so many varied angles. Its like women and men aren't fascinated unless it is one thing to accomplish with Lady gaga! Your own stuffs nice. Always maintain it up!

    http://www.stornobrzinol.com/

    May 15, 2021 at 08:10 | Report abuse | Reply
  38. brimonidine

    combigan side effects combigan generic prices

    May 15, 2021 at 20:38 | Report abuse | Reply
  39. LebnEncox

    cheap drugs online http://xlnpharmacy.com/ shoppers drug mart pharmacy

    May 16, 2021 at 07:12 | Report abuse | Reply
  40. Didral

    cialis irregular heartbeat generic cialis dangers cialis legale italia

    May 16, 2021 at 07:31 | Report abuse | Reply
  41. Paul Bermingham

    I don't know about you all but I love airplanes. I had a friend in highschool that loved airplanes, so here are some airplane related stuff I don't know about you guys but I love airplanes. I had a friend in highschool that loved airplanes, so here are some airplane related stuff https://www.airlinereporter.com/2010/09/three-videos-boeing-747-has-wicked-landing/

    http://urlm.co/g/c/f/163870

    May 16, 2021 at 15:22 | Report abuse | Reply
  42. storno brzinol

    Have you ever considered creating an ebook or guest authoring on other blogs? I have a blog centered on the same subjects you discuss and would really like to have you share some stories/information. I know my subscribers would appreciate your work. If you are even remotely interested, feel free to send me an e-mail.

    http://www.stornobrzinol.com/

    May 16, 2021 at 15:40 | Report abuse | Reply
  43. Didral

    vidal cialis 5 mg cialis generic does cialis cause priapism

    May 17, 2021 at 03:57 | Report abuse | Reply
  44. GtnbCrulk

    is viagra bad for you https://jokviagra.com/ viagra vs cialis hardness

    May 17, 2021 at 04:00 | Report abuse | Reply
  45. Zack Wagers

    Have you ever heard of second life (sl for short). It is basically a online game where you can do anything you want. SL is literally my second life (pun intended lol). If you would like to see more you can see these second life authors and blogs

    http://everydayliteracies.blogspot.com/2003/04/what-video-games-have-to-teach-us-jim.html?showComment=1507704075915

    May 17, 2021 at 06:02 | Report abuse | Reply
  46. GtnbCrulk

    viagra and high blood pressure http://jokviagra.com/ – viagra company how do i get viagra

    May 17, 2021 at 06:50 | Report abuse | Reply
  47. RebfZisse

    cialis online without prescription http://rcialisgl.com/ cialis paypal bezahlen

    May 17, 2021 at 15:01 | Report abuse | Reply
  48. Marvin Rappold

    I don't know about you people but I am obsessed with airplanes. I have a friend in highschool that loves airplanes, so here are some airplane related stuff I don't know about you guys but I love airplanes. I had a friend in highschool that loved airplanes, so here are some airplane related stuff https://www.airlinereporter.com/2011/01/photo-united-airlines-new-livery-on-an-airbus-a319/

    http://www.pseconline.org/pipermail/reps_pseconline.org/2012-November/000869.html

    May 17, 2021 at 16:41 | Report abuse | Reply
  49. FmrfEncox

    sams club cialis https://cialisee.com/ – low cost cialis generic cialis uk online

    May 17, 2021 at 17:04 | Report abuse | Reply
  50. JebgEncox

    go coupon https://pharmacylo.com/ Noroxin

    May 17, 2021 at 18:11 | Report abuse | Reply
1 2 3 4 5 6 7

Post a comment


 

CNN welcomes a lively and courteous discussion as long as you follow the Rules of Conduct set forth in our Terms of Service. Comments are not pre-screened before they post. You agree that anything you post may be used, along with your name and profile picture, in accordance with our Privacy Policy and the license you have granted pursuant to our Terms of Service.

Advertisement
About this blog

Get a behind-the-scenes look at the latest stories from CNN Chief Medical Correspondent, Dr. Sanjay Gupta, Senior Medical Correspondent Elizabeth Cohen and the CNN Medical Unit producers. They'll share news and views on health and medical trends - info that will help you take better care of yourself and the people you love.