The first over-the-counter, oral swab HIV test, under development by Bethlehem-based OraSure Technologies, is one step closer to approval after an FDA advisory committee gave the product its unanimous recommendation last month.
The OraQuick In-Home HIV Test has been under development for six years as a direct-to-consumer version of OraSure’s oral rapid HIV test — the only such product on the market, currently sold only to doctors and other healthcare professionals. "If all goes well," says Ron Ticho, OraSure’s senior vice president for corporate communications, "we hope to see approval in the coming months."
The new HIV test, which would be the first FDA-approved home test for any infectious disease, has huge healthcare implications. The Centers for Disease Control and Prevention estimate that there are about 1.2 million people in the U.S. with HIV and about 240,000 of them are unaware of their status.
The product is also potentially huge for OraSure, with one analyst telling the Philadelphia Inquirer that the test could generate $50 million in annual sales at the end of five years. OraSure is also pegging its growth to two 2011 developments: FDA approval of its rapid hepatitis C test and its acquisition last year of DNA Genotek, a Canadian firm that is a leading provider of oral fluid sample collection, stabilization and preparation products. Genotek, for example, just sold its saliva collection kit to a genetic testing company specializing in Scottish ancestry.
OraSure was established in 1987 and is an alumni client of Ben Franklin Technology Partners of Northeastern Pennsylvania. Today the company employs about 235 and serves a global market.
Source: Ron Ticho, OraSure Technologies
Writer: Elise Vider