OraSure Technologies‘ recent introduction of OraQuick, a rapid at-home HIV test, means quick test results in the comfort (and privacy) of your home. The test could mean awareness for the roughly 240,000 Americans unknowingly living with the virus. Still, the path to FDA approval was anything but fast. OraSure CEO Douglas Michels guides us through the seven-year process.
In 2005, Michels approached the FDA about approving the company’s rapid in-home HIV test. A professional version of the test had already sold more than 25 million units.
Understandably, the FDA worried about delivering the diagnosis of such a serious disease to people in the solitude of their homes, rather than in a doctor’s office.
OraSure went through 32 prototypes and four years of clinical studies to eliminate common errors. The final version uses a simple mouth swab rather than a finger prick, and delivers a result in 20 to 40 minutes.
Clinical studies have shown that the OraQuick test is 99.98% accurate when a person does not have HIV; for those infected with the virus, the test is 92% accurate, meaning one false negative is expected out of every 12 tests.
The FDA asked two questions of the Blood Products Advisory Committee: Do the benefits outweigh the risks of false results, and do the available data assure that the test is safe? This spring, they unanimously voted yes.