FDA Committee Approves OraSure's Over-the-Counter, In-Home HIV Test

FDA Committee Approves OraSure's Over-the-Counter, In-Home HIV Test

The first ever over-the-counter, in-home HIV test is one step closer to being sold on the market for consumers. The U.S. Food and Drug Administration Blood Products Advisory Committee (BPAC) panel of 17 experts unanimously concluded that the OraSure Technologies Inc's test, OraQuick, is reasonably safe and effective for determining someone's HIV status.

BPAC voted on two questions posed by the FDA:

  • Do the projected benefits of the test outweigh the potential risks of false positive and false negative test results?
  • Do the available data provide reasonable assurance that the test is safe and effective for its intended use?

The committee voted 17-0 affirmative to both questions.

The recommendations of the committee will now be reviewed by agency regulators.

AIDS United is supportive of OraSure's application for approval of the OraQuick over-the-counter, in-home HIV test. AIDS United's major recommendations include:

  • Ensuring linkage to counseling and treatment and prevention services. OraSure has established a 24-hour HIV test support center. AIDS United has recommended that the FDA, as well as OraSure, monitor the testing center's operations and impact on consumers
  • Including labeling and instruction materials that stress the importance of getting a follow-up test in the event of a positive result. The over-the-counter, in-home version of OraQuick has been shown to be 99.3% effective at identifying HIV infection
  • Preparing the test support center to make people aware of state and local criminal statutes regarding HIV transmission. People who test positive should be urged to seek legal advice about how best to protect themselves from criminal prosecution

Click here to read the full version of AIDS United's comments.

Click here for FDA's Issue Summary.

Click here for OraSure's briefing document.