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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.

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Patient: Alzheimer's plan OK, but too late for me
Phil Kreitner, 72, has mild cognitive impairment. He supports research for Alzheimer's disease.
May 15th, 2012
11:16 AM ET

Patient: Alzheimer's plan OK, but too late for me

When Phil Kreitner’s wife Sherril Gelmon comes home and asks what he did all day, he has to pause to think. It’s hard enough to remember what he did five minutes ago. And where he keeps the different cereals he likes to mix in the morning.

Kreitner, 72, of Portland, Oregon, is one of many aging Americans living with mild cognitive impairment, a condition marked by memory impairment that may progress into the more severe Alzheimer’s disease. He’s participating in a clinical trial aimed at testing a treatment for dementia, and believes furthering research is critical for combating the brain disease.

"I walk around all [expletive] day telling myself 'Why can’t you remember that? You’ve got to remember that! Why aren’t you remembering that? How can you try to remember that?' ” says Kreitner, who was the subject of a CNN profile in 2011.

He’s excited that the Obama administration has committed to investing in more clinical trials for Alzheimer’s disease, with the goal of effective treatment and prevention by 2025. But when that deadline arrives, Kreitner isn't sure he'll still be around - he may not live to see the benefits of that research.
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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.

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