FDA advisory committee to review OTC availability of HIV test in May


BETHLEHEM, Pa. — OraSure Technologies on Wednesday announced that the Food and Drug Administration's Blood Products Advisory Committee will consider making its OraQuick Rapid HIV-1/2 test available over the counter on May 15.

At the meeting, OraSure will present its consumer-usage studies — approximately 5,800 subjects were enrolled and tested in this phase across 20 states, the company said, which helped identify more than 100 previously undiagnosed individuals.

"There is an urgent need for additional testing options to identify individuals who are HIV- positive, link them to care and reduce transmission of the virus," OraSure president and CEO Douglas Michels said. "Our belief is that the availability of an easy-to-use, accurate in-home HIV test will enable more people to learn their presumptive HIV status so that they can receive necessary care and support."

According to the Centers for Disease Control and Prevention, there are approximately 1.2 million people in the United States who have HIV and despite current HIV testing options, approximately 240,000 of them are unaware of their status. It is estimated that those undiagnosed are responsible for up to 70% of the approximately 50,000 new HIV infections occurring each year in the United States. The CDC recommends all people ages 13 to 64 years be offered an HIV test in healthcare settings, with more frequent testing for people at higher risk.

Citing clinical studies conducted by OraSure, the CDC noted the OraQuick oral fluid test correctly identified 99.3% of people who were infected with HIV (sensitivity) and 99.8% of people who were not infected with HIV (specificity). The Food and Drug Administration expects clinical laboratories will obtain similar results.

The OraQuick rapid HIV test for use with blood was waived under the Clinical Laboratory Improvements Amendments of 1988 in January 2003, and waived for use with oral fluid in June 2004. A waived test can be used in any facility with a CLIA certificate, rather than only in traditional laboratories. As such, a waived test can be used in many non-clinical settings.

Such was the case last summer when Walgreens teamed with Greater Than AIDS on a national awareness campaign around HIV/AIDS in the United States, to distribute informational resources and specialized HIV-related services at more than 300 Walgreens pharmacies in affected communities.


At these specialized pharmacy locations, Walgreens had pharmacists on hand to offer one-on-one medication counseling and other support services that provide customers living with HIV/AIDS and their families with compassionate, confidential care. Free rapid oral HIV testing was available at select Walgreens with technical support and guidance from the Centers for Disease Control and Prevention and test kits from OraSure Technologies.


State and local health departments and community-based organizations in the local markets conducted the tests and providing pre- and post-test counseling.

That means this could be the first switch application that could significantly benefit from a pharmacist or nurse practitioner intervention in the wake of last month's FDA public meeting on expanding the switch paradigm. One of the concerns associated with an OTC HIV test is the availability of counseling following a positive/false positive result. The OraQuick Rapid HIV point-of-care test produces results in 20 minutes — and if that 20 minutes transpires in a pharmacist or nurse clinician consultation room a person finding out that they are HIV positive would have immediate access to a healthcare professional.

To review the OraQuick Advance package insert, a product presently available to clinicians, click here.

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