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 (393 Responses)
  1. AhmdEncox

    buy cialis online in canada walgreens pharmacy online real cialis sublingual https://impotencecdny.com/ – Viagra with Fluoxetine ’

    January 30, 2021 at 01:22 | Report abuse | Reply
  2. KbbgMile

    viagra for sale canada pharmacy drug store viagra generika china http://erectilejyzd.com/ – canadadrugs pharmacy ’

    January 31, 2021 at 11:32 | Report abuse | Reply
  3. JnscCrulk

    canadian pharmacy viagra 20mg viagra 20mg tablets price viagra generic http://erectilejyzd.com/index.php?called=terms – viagra sample pack ’

    February 1, 2021 at 17:15 | Report abuse | Reply
  4. Johnywpr

    studies April 24

    beauty of "the easy swing" Is that it is a system. many people action with the pitch, yet hardly really think about what they carried out not true, Or also, whatever they managed to do authority.

    tips for the 2006 actively playing golf Season

    The 2006 the game charmdate scam months are just around the corner for many individuals. for those who are that are fortunate enough to reside in a region that enable you to play the game of golf all climates and seasons, these pointers will still be useful. cheer take minutes t.

    briefly gameplay ideas That will vary how you review from the inside 50 metres

    within the next 15 or so minutes, i am about to change how you will have fun playing you are photos from the inside 50 yards. If you make payment for 15 minute ahead of when big round of golf of all golfing for those same four techniques, occasions the cerebral vascular accidents are going to n.

    How to get additional feel together with your person

    see this heading if so prohibit for the purpose of 10 a few moments and look carefully to see how you feel the three considerable outside climate to golf get. Four, three, two, one.

    robert Selden

    encouraging more it is possible to Real answer?

    quality business articles April 24, 2006

    identical,if you're an employer, manager, trainer also or even, we all have been a few point state excited to discover advice to the oh so common ponder along with "strategy to propel other brands, baby trend Selden of the nation's starting to learn initiate.

    February 5, 2021 at 08:08 | Report abuse | Reply
  5. FqhhEncox

    non prescription online pharmacy reviews canadian pharcharmy online fda approved skin care

    February 5, 2021 at 17:38 | Report abuse | Reply
  6. AhkdEncox

    mexican pharmacy online medications erection pills prescription price comparison

    February 5, 2021 at 22:10 | Report abuse | Reply
  7. LbsxEncox

    canadian pharmacy online canada buy viagra with paypal uk pharmacy online prescription

    February 6, 2021 at 17:51 | Report abuse | Reply
  8. zortilonrel

    I real thankful to find this internet site on bing, just what I was searching for : D likewise bookmarked.

    http://www.zortilonrel.com/

    February 7, 2021 at 03:22 | Report abuse | Reply
  9. zortilonrel

    I too conceive thus, perfectly composed post! .

    http://www.zortilonrel.com/

    February 7, 2021 at 10:23 | Report abuse | Reply
  10. zortilo nrel

    You have remarked very interesting details! ps decent site.

    http://www.zortilonrel.com/

    February 7, 2021 at 16:09 | Report abuse | Reply
  11. Kuikseelt

    genric viagra where can you buy viagra with paypal? generic viagra

    February 7, 2021 at 23:33 | Report abuse | Reply
  12. JbbvEncox

    canada pharmacy no prescription quit smoking canada pharmacy online no script

    February 7, 2021 at 23:58 | Report abuse | Reply
  13. NncsZisse

    viagra and high blood pressure medication viagra asutralia buy viagra online cheap

    February 8, 2021 at 10:23 | Report abuse | Reply
  14. JbnbCrulk

    trust pharmacy canada canadian pharmacy no prescription canadian online pharmacies prescription drugs

    February 8, 2021 at 13:14 | Report abuse | Reply
  15. https://europa-road.eu/

    Hi there, simply became alert to your weblog via Google, and located that it's really informative. I am gonna be careful for brussels. I will appreciate in case you proceed this in future. Lots of people will probably be benefited from your writing. Cheers!

    https://europa-road.eu/

    February 9, 2021 at 03:35 | Report abuse | Reply
  16. tengeri szállítmányozás Europa-Road Kft

    We are a group of volunteers and starting a new scheme in our community. Your web site provided us with valuable information to work on. You have done a formidable job and our whole community will be grateful to you.

    https://europa-road.eu/hu/tengeri-szallitmanyozas.php

    February 9, 2021 at 03:55 | Report abuse | Reply
  17. http://www.fokuszpalyazat.hu/rolunk

    After I originally commented I clicked the -Notify me when new feedback are added- checkbox and now each time a comment is added I get 4 emails with the identical comment. Is there any manner you possibly can take away me from that service? Thanks!

    http://www.fokuszpalyazat.hu/rolunk

    February 9, 2021 at 04:17 | Report abuse | Reply
  18. Cardiff House Clearance

    I do believe all the ideas you've offered for your post. They're very convincing and can certainly work. Nonetheless, the posts are too short for novices. May just you please extend them a little from subsequent time? Thanks for the post.

    http://www.dumpawaste.co.uk

    February 9, 2021 at 07:27 | Report abuse | Reply
  19. FvfcZisse

    viagra australai price viagra canada pharmacies online pharmacy

    February 9, 2021 at 17:20 | Report abuse | Reply
  20. KbcxMile

    buy viagra pharmacy 100mg canadian pharmacy 365 legitimate online pharmacies

    February 9, 2021 at 23:06 | Report abuse | Reply
  21. AqcfTeneseelt

    buy cheap cialis online with mastercard buy cialis 20mg tablets cialispills online

    February 10, 2021 at 17:51 | Report abuse | Reply
  22. FqbbEncox

    consolidate payday loans fast loans and advances in tally cash advance phenix city

    February 12, 2021 at 17:38 | Report abuse | Reply
  23. AhbzEncox

    payday loan dixie hwy payday loans 90034 hemet cash loans

    February 13, 2021 at 01:08 | Report abuse | Reply
  24. LabxEncox

    cialis per rechnung cialis lilly icos tadalafil cialis preguntas y respuestas

    February 13, 2021 at 14:51 | Report abuse | Reply
  25. Kbbfseelt

    viagra with dapoxetine online viagra for sale with a prescription in las vegas nv brand viagra

    February 14, 2021 at 08:06 | Report abuse | Reply
  26. JbbnEncox

    united pharmacy cialis cialis ou levitra forum cialis nao faz efeito

    February 15, 2021 at 16:24 | Report abuse | Reply
  27. JbnvCrulk

    payday loans norco ca low interest online payday loans cash in advance espaРіВ±ol

    February 16, 2021 at 00:26 | Report abuse | Reply
  28. NbnhZisse

    order sildenafil online http://vigedon.com/ vigra

    February 16, 2021 at 13:33 | Report abuse | Reply
  29. Bitcoin friendly VPS provider

    217896 549495Hello there, just became alert to your blog via Google, and discovered that it is truly informative. Im gonna watch out for brussels. Ill be grateful if you continue this in future. Many people will probably be benefited from your writing. Cheers! 273045

    February 16, 2021 at 21:46 | Report abuse | Reply
  30. KvaxMile

    approved cash advance selma al cash advance on telegraph payday loans by mobile phone

    February 17, 2021 at 08:39 | Report abuse | Reply
  31. FbsgZisse

    cialis dosage strengths http://llecialisjaw.com/ original cialis com

    February 17, 2021 at 17:50 | Report abuse | Reply
  32. regulation cornhole rules

    482750 312124Oh my goodness! an remarkable post dude. Thank you Even so My business is experiencing issue with ur rss . Dont know why Unable to subscribe to it. Can there be anyone obtaining identical rss issue? Anybody who knows kindly respond. Thnkx 808864

    February 19, 2021 at 19:02 | Report abuse | Reply
  33. pc repair

    I truly appreciate this post. I’ve been looking all over for this! Thank goodness I found it on Bing. You've made my day! Thanks again

    https://cds-consultants.com

    February 21, 2021 at 05:23 | Report abuse | Reply
  34. ClarkTauts

    8dzeh dbaef u80k

    February 28, 2021 at 20:41 | Report abuse | Reply
  35. NbmoZisse

    where can i buy cialis in singapore http://buycialisxz.com/ cialis professional india

    March 3, 2021 at 02:30 | Report abuse | Reply
  36. FjjuZisse

    what happens when a woman takes male viagra what is viagra pills lemonaid health viagra reviews

    March 4, 2021 at 02:49 | Report abuse | Reply
  37. Harmannji

    obtain fantastic dating site practices

    If you want dating tactics then this is the right one for you. particular person shall be eager to find the best husband in their life. seeing assists them to to opt for the certain previously marrying them. obtain the information on dating based in online dating service personals good tips; you will find the information going with your lover. Find the absolute right place for your evening with your relationshipr. there are plenty of things happen due to romance, anybody may just be joking loudly on the other hand checking cellphones when they are in the bistro. there's a lot of things that make the a relationship failing one. using a few selected rules for the duration of seeing times makes married couples very happy. try to be timely in the consort with as it permits the sense that you don't take care of them. fit your soulmate as numerous amounts attain an extra energy and effort in dressing up with regards to their night. may definitely restless inside the schedules despite the fact that try to restore meet Russian women a good time. inquire questions below; take notice of them attentively furthermore oddly enough on what it is said reveal to interest. embark on wedding date with people to whom you want properly fascinate, not with yet another you cannot are keen on or your entire associates indicated and romance relationship does not ever exists for long period. if you are a woman and wish to know more dating material or likes to find your husband or wife, do a little analysis on the web and search through google basically keying the word what much like a lot of women internet dating, single women matchmaking tips and internet based. a variety of web page who work for using the net. have the overview of the location and choose your husband or wife in something. If you will not be keen on going out with with the patient otherwise consulting with all of them therefore, please say so as they do not bide time until you, and they will have a chance to find anyone else. If you choose the right a person you can make, specific your love inside him.

    March 20, 2021 at 02:41 | Report abuse | Reply
  38. https://www.songmanhits.com

    I have never seen this view !

    https://images.google.com.my/url?q=https://www.songmanhits.com

    March 21, 2021 at 17:20 | Report abuse | Reply
  39. go to this website

    686259 286215The vacation unique deals offered are believed as a selection of possibly the most preferred and therefore within your budget all more than the globe. Quite several hostels can be proudly located inside property which is accented who has striking seashores encouraging crystal-clear rivers, contingency of an Ocean. hotels compare rates 596415

    March 23, 2021 at 23:41 | Report abuse | Reply
  40. FbshEncox

    https://thesisacloud.com/ – thesis proposal writing service thesis proposal help thesis proposals thesis data analysis

    March 24, 2021 at 04:29 | Report abuse | Reply
  41. AbgcEncox

    https://thesiswritingtob.com/ – thesis research proposal thesis proposal example thesis editors help with thesis statement

    March 24, 2021 at 10:05 | Report abuse | Reply
  42. Perry Mccurren

    hi!,I really like your writing so so much! share we keep in touch more about your post on AOL? I need a specialist on this space to resolve my problem. Maybe that's you! Having a look ahead to peer you.

    http://www.froleprotrem.com/

    March 25, 2021 at 00:07 | Report abuse | Reply
  43. LmoppEncox

    http://essaywriteris.com/ – essay writers essay writer generator cheap essay writers pay for essay cheap

    March 25, 2021 at 06:24 | Report abuse | Reply
  44. JvqqEncox

    https://dissertationahelp.com/ – dissertation help uk dissertation introduction dissertation for dummies dissertation help literature review

    March 26, 2021 at 07:46 | Report abuse | Reply
  45. FbshEncox

    https://thesisacloud.com/ – good thesis statements thesis statistics help thesis help services good thesis

    March 26, 2021 at 22:53 | Report abuse | Reply
  46. AbgcEncox

    https://thesiswritingtob.com/ – write a good thesis help with a thesis statement help with a thesis statement help me write a thesis

    March 27, 2021 at 04:46 | Report abuse | Reply
  47. Marcelo Lanehart

    http://tinyurl.com/j7faf4f

    March 29, 2021 at 14:33 | Report abuse | Reply
  48. GrvCrulk

    https://kloviagrli.com/ – 150 mg viagra https://vigedon.com/ – get viagra online https://llecialisjaw.com/ – cialis 20 mg how long does it take to work https://jwcialislrt.com/ – is cialis generic https://jecialisbn.com/ – is cialis generic

    March 30, 2021 at 12:35 | Report abuse | Reply
  49. FbshEncox

    https://thesisacloud.com/ – thesis writing help help with thesis writing thesis assistance thesis for dummies

    April 1, 2021 at 04:19 | Report abuse | Reply
  50. AbgcEncox

    https://thesiswritingtob.com/ – phd thesis writing services thesis writing services uk help in thesis writing thesis abstracts

    April 1, 2021 at 10:00 | Report abuse | Reply
1 2 3 4 5 6 7 8

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.