First In-Home HIV Test Approved

Courtesy of OraSure Technologies

The first-ever in-home oral HIV test has been approved this week by the FDA. OraSure Technologies‘ OraQuick – a rapid, oral HIV test – is expected to be available in October.

The CDC estimates that 1.2 million people in the U.S. are living with HIV, but as many as 240,000 may be unaware they’re positive. And those who don’t know their status may be responsible for up to 70 percent of the 50,000 new infections each year. But routine screenings at clinics, health centers – and now at home – could cut back on thousands of new infections.

“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 a referral to care if needed,” says Douglas A. Michels, president and CEO of OraSure. “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.”

Each test kit – which will be available at more than 3o,000 retailers around the country this fall – includes the test itself and access to a live toll-free customer support center with experts available to answer questions about HIV and AIDS, and to describe how to use the test and read results. The center will begin taking calls starting this month (July 9) at 866-435-6527.

“We set out with a clear purpose,” says Michels, “to dramatically impact the number of people getting tested for HIV nationwide.”

Do you know your HIV status? Would this device make you more or less likely to get tested?