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BETHLEHEM, Pa. — OraSure Technologies Inc. has received approval from the Food and Drug Administration for its OraQuick In-Home HIV Test, which the company called the nation’s first and rapid, over-the-counter HIV test.
The oral swab kit is slated to become available online and at retailers nationwide this fall, OraSure said this week.
According to the company, the OraQuick test can detect antibodies to both HIV-1 and HIV-2, providing a confidential in-home testing option with results in 20 to 40 minutes. A previous OTC test for HIV required a user to prick a finger and mail a drop of dried blood to a laboratory.
The new test is the first rapid diagnostic test for any infectious disease that has ever been approved by the FDA for sale over the counter, OraSure reported.
"Approval of the OraQuick In-Home HIV Test represents a major breakthrough in HIV testing," OraSure president and chief executive officer Douglas Michels said in a statement Tuesday. "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."
According to the Centers for Disease Control and Prevention (CDC), nearly 1.2 million people in the United States have HIV, and about 240,000 of them are unaware of their status. Those who do not know they are HIV positive are disproportionately responsible for the 50,000 new HIV infections that occur each year, the CDC says.
The new test is a self-administered version of a rapid test the FDA approved for use in medical settings in 2004. The first application for an at-home HIV test was made in 1987, and the FDA has been considering OraSure’s mouth-swab test since 2005.
In approving the home test, FDA regulators noted that they do not intend for it to replace medical testing, but instead to provide another way for people to find out their HIV status.
OraSure’s Michels said the home test should be available in 30,000 drug stores, supermarkets and online retailers by October.
While Michels said the retail price of the test has not yet been set, he expects the product to carry a price point higher than the $17.50 now charged to medical professionals because the company will do more complicated packaging for the home kit; open a 24-hour question line; and advertise to high-risk groups, including gay men, blacks and Hispanics, and sexually active adults.
Still, he said he expects pricing to be kept inexpensive enough to appeal to people who might want to buy several a year.
"We set out with a clear purpose — to dramatically impact the number of people getting tested for HIV nationwide," Michels stated. "The FDA approval brings us much closer to accomplishing that goal."
