BETHLEHEM, Pa. – The product that put OraSure on the map more than two decades ago is expanding its reach.
On Tuesday the Bethlehem-based maker of at-home diagnostic tests announced that its OraQuick HIV test will be launched in Canada.
The self-test can be used at home. It detects antibodies for both HIV-1 and HIV-2 with a simple oral swab. Results are available in as little as 20 minutes.
“Expanding access to HIV testing options is a critical component in the global effort to end the HIV epidemic,” said Carrie Eglinton Manner, President and CEO of OraSure, in a news release. “Early diagnosis and linkage to care remain essential for improving health outcomes.”
OraSure first received approval for its groundbreaking OraQuick test from the Food and Drug Administration in 2002. At the time, the test had to be administered in a clinical setting.
OraQuick was approved for over the counter, at-home use in 2012. It’s now available in more than 60 countries around the world.
The expansion comes as OraSure seeks a return to growth in 2026, following a post-Covid-19 pandemic slowdown. Last week, the company told 69 News it was reducing its non-production workforce in the U.S. and Canada as it works to rebalance its cost structure and support investments in its product roadmap.
OraSure trimming global workforce, including here in Lehigh Valley
The total reduction “equates to a mid-single digits percent” of the overall global workforce, a spokesperson said. Ten positions at OraSure’s headquarters in Bethlehem are among the cuts.
OraSure’s global headquarters is based at 220 E. First St. on Bethlehem’s Southside. It also has a site across the street at 150 Webster St., where it houses corporate offices and research and development; and manufacturing and warehouse space at 2685 Opus Way in Bethlehem Township.
OraSure is also the parent company of DNA Genotek, Inc. in Canada, and Sherlock Biosciences, which has locations in Massachusetts and the United Kingdom.
The company will announce its fourth quarter 2025 financial results on Feb. 25.