FDA Approval of HIV Home Test Paves Way For More Personalized Medicine

  • by: |
  • 05/16/2012
This is a building block for personalized and consumer driven medicine.  It will be hard to stop retail sales of other tests, including genomic-based tests that measure treatment response, after this vote.   I can't wait to see the teeth gnashing from Public Citizen, Merrill Goozner and other anti-innovation scolds. 

Home HIV test should be sold in retail stores, US panel urges
Published May 16, 2012

A Food and Drug Administration advisory panel Tuesday asked the agency to let an HIV test be sold in retail stores so consumers do not have to go to a health facility to get tested for the virus.

The mouth-swab test, made by OraSure Technologies Inc., is sold commercially to health professionals to be used at facilities.
If approved by the FDA, the test results could be obtained in the home like tests for pregnancy and blood sugar. The FDA usually follows panel recommendations.

The test was reviewed Tuesday by the FDA's blood-products advisory panel, which is made up of non-FDA medical experts.
The panel voted 17-0, saying the "projected benefits" of OraSure's in-home HIV test outweighed the "potential risks of false positive and false negative results." The panel also voted 17-0 in support of a question that asked if the data submitted by OraSure showed the test was safe and effective.
If the OraQuick In-Home HIV Test is approved, it would mark the first time that HIV test results could be obtained in the home. Other home HIV tests require a fluid sample to be sent to a laboratory for testing.

About 1.2 million people in the US are infected with HIV, and about 50,000 infections are diagnosed each year, a level that has been stable for a decade. Federal health officials estimate 20 percent of people with HIV do not realize they are infected and risk spreading the virus.
OraSure argues the test would most benefit people at risk who have never been tested or do not get tested regularly.

One concern about the home test is it does not appear as accurate as tests conducted by health professionals. The company conducted a study of the home test in 5,662 people who also took a traditional HIV laboratory test that used blood. Blood tests showed 114 people were positive for HIV. Of that group, 106 reported positive tests via the home test, and eight reported a negative test.

It is not clear if the home test provided a negative result or if people read the test incorrectly. Still, FDA officials said the home-use test would likely encourage more people to get tested. "We believe there would be public-health benefits" of a home-based HIV test, said Richard Forshee, an FDA associate director for research. "But an individual risk remains in the form of an increase in the number of false negatives."


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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