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.