OraSure's OTC HIV test obtains crucial FDA panel backing

There isn't an approved over-the-counter home HIV diagnostic test yet. But OraSure stepped even closer to that milestone on Tuesday, when the FDA's Blood Products Advisory Committee voted unanimously to recommend approving the company's product.

An advisory panel vote isn't binding, but the FDA typically follows the vote recommendation. And gaining approval for the OraQuick In-Home HIV Test for over-the-counter use would be a significant enough change in diagnostics care for the virus that a variety of news sources have covered the vote, including MedPage Today, The Philadelphia Inquirer, The Wall Street Journal and BBC News. Typically, patients seeking testing must go to a health care facility.

An FDA reviewer at the hearing predicted that in a best-case scenario, 2.8 million people would use the test. What's more, regulators believe its use could ideally help identify 45,000 new positive test results annually, MedPage Today reports, and stop 4,000 HIV transmissions per year. (Arguably, part of the reason is this: An over-the-counter diagnostic test for HIV enables greater privacy, and could encourage some patients to get tested when they otherwise wouldn't.)

OraSure, which is based in Bethlehem, PA, touts the 20-minute test as being 93% accurate for positive results, but 99.8% accurate for negative findings, according to BBC News. That's based on clinical trials conducted thus far. The test, which could cost less than $60, involves swabbing the outer gum to gather oral fluid, and that swab is then inserted into a vial of test fluid. The test strip develops two colored lines if a patient has HIV, MedPage Today explains. With a positive result, patients would be able to use an information booklet to contact an HIV support center managed by OraQuick, 24 hours a day. BBC News points out, however, that some experts believe a blood-based diagnostic test for HIV is more accurate and reliable.

OraSure also produces non-over-the-counter diagnostics tests for HIV, hepatitis C, influenza, and also tests that detect alcohol or drug use.

- read the MedPage Today story
- check out BBC News' take
- here's The Philadelphia Inquirer's coverage
- consider The Wall Street Journal's story