|Courtesy of OraSure|
OraSure ($OSUR) made diagnostics history in July when the FDA approved OraQuick, the first over-the-counter HIV test cleared for use in the U.S. The test retails for about $40 a pop, and analysts project that it will bring in more than $20 million in sales this year.
The test is an at-home version of the company's lab-based diagnostic, and, using an oral swab, it can detect antibodies of HIV-1 and HIV-2 in about 20 minutes. The FDA estimates that it could lead to 45,000 positive results annually, identifying HIV-positive patients who may not have otherwise known of their infections.
To use OraQuick, patients swab their gums and put the swab into a vial of fluid. Two colored lines mean a positive result, and an accompanying booklet and 24-hour HIV information hotline explain what to do next.
The test is 93% accurate for positive results and 99.8% accurate for negatives, and while industry-standard lab-based blood tests provide 99% accuracy in positive diagnoses, the FDA deemed OraQuick's efficacy good enough because of the effect it could have on the estimated 250,000 people at risk for HIV who don't get tested.