FDA approves OraSure's at-home HIV test

OraSure ($OSUR) has secured FDA approval for its over-the-counter HIV diagnostic, the first of its kind, and the company's shares promptly jumped by 6%, The Wall Street Journal reports.

OraQuick 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, according to the company. Assuming the device sells for $40 a pop, it could bring in about $20 million in sales by next year, one analyst told Bloomberg.

The approval follows a panel recommendation back in May, when regulators estimated that OraSure's tech could lead to 45,000 positive results annually, identifying HIV patients who may not otherwise have known of their infections. All of this has been a boon to OraSure's business: Its shares have been on the rise since the panel vote, and they've jumped by 36% over the past year, Bloomberg notes.

OraSure's oral-swab test is 93% accurate for positive results and 99.8% accurate for negatives, the company says. Industry-standard blood tests provide 99% accuracy in positive diagnoses, but the FDA says that discrepancy is manageable considering the dent OraQuick could put in the estimated 250,000 people at risk for HIV who don't get tested.

To use the device, which the company plans to launch in October, patients swab their gums to gather saliva and put the swab into a vial of fluid. Two colored lines indicate a positive result, and an accompanying booklet explains what to do next. OraSure will also maintain a 24-hour HIV information center for patients.

- read the company's statement
- here's Bloomberg's report
- get more from the WSJ

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