FDA Approves First In-Home HIV Test

The U.S. Food and Drug Administration (FDA) approved the OraQuick® In-Home HIV Test for sale in the over-the-counter (OTC) market – making it the first and only rapid over-the-counter HIV test approved in the U.S.

“Approval of the OraQuick® In-Home HIV Test represents a major breakthrough in HIV testing,” said Douglas A. Michels, president and chief executive officer of OraSure Technologies in a statement to press. “For the first time ever, individuals will have access to an in-home oral test that will empower them to learn their HIV status in the comfort of their home and obtain referral to care if needed. This new in-home rapid test – the same test doctors have used for years – will help individuals at risk for HIV who otherwise may not test in a professional or clinical setting.”

It’s an over-the-counter version of the company’s OraQuick ADVANCE® HIV 1/2 Antibody Test, the market leading rapid HIV test with millions of units sold to hospitals, clinics, community-based organizations and physician offices.

The in-home test is expected to be available for purchase this October at more than 30,000 retail outlets throughout the country and online.

“We set out with a clear purpose – to dramatically impact the number of people getting tested for HIV nationwide,” added Michels. “Today’s FDA approval of OraQuick brings us much closer to accomplishing that goal.” –yvette caslin

For information about the OraQuick In-Home HIV Test, visit OraQuick.com.


Yvette Caslin
Yvette Caslin

I'm a writer, image architect & significance marketer. Love photojournalism, creative expression & originality.

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