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Orasure In-Home HIV Test Gets Unanimous Approval Recommendation
Orasure’s oral swab-based rapid in-home HIV test has been recommended for approval by the U.S. Food and Drug Administration’s Blood Products Advisory Committee. If the FDA follows its advisory committee’s recommendation, the Oraquick In-Home HIV Test will be the first complete home-based screening assay for any infectious disease available for purchase over-the-counter (OTC) from pharmacies and internet retailers.

Revolutionary HIV Tests Needed at Home and Globally

Michael Schreiber, managing director of GBCHealth, a coalition of more than 200 companies actively engaged in global health, submitted this op-ed in response to the approval of rapid in-home HIV tests. He writes:

It was once considered a stretch of the imagination to be able to take an HIV test in the privacy of one’s own home and to receive the results almost immediately. Now, those at risk— or who think they may be at risk— will be able to find out their HIV status using an over-the-counter testing kit that gives results in just 20 minutes.

This week the Food and Drug Administration approved a revolutionary new in-home HIV test. Beginning in October, people can buy a simple, oral swab test from their drugstore or online and learn with 99.9 percent accuracy if they’re HIV-free and, with 92 percent accuracy, if they’re HIV positive. Click here for more.

In-Home Swab Passes Test

Orasure’s oral swab-based rapid in-home HIV test has been recommended for approval by the U.S. Food and Drug Administration’s Blood Products Advisory Committee. If the FDA follows its advisory committee’s recommendation, the Oraquick In-Home HIV Test will be the first complete home-based screening assay for any infectious disease available for purchase over-the-counter (OTC) from pharmacies and internet retailers.

The advisory committee voted unanimously, 17-0, in favor of the test upon being asked two questions: Do the available clinical trial results provide reasonable assurance that the test is safe and effective? And, importantly, do the benefits of in-home HIV testing outweigh the potential risks, notably false negative and false positive results?

Click here for more.