FDA Clears OraSure's At-Home STI Test Kit, Expanding Access with Roche Partnership
OSUR sits 100% above its 52-week low of $2.08.
Summary
OraSure Technologies secured FDA clearance for its Colli-Pee™•Dx Urine Collection Kit, allowing at-home self-collection for sexually transmitted infection (STI) testing. This kit is compatible with Roche's molecular diagnostic systems, enabling convenient and private testing for Chlamydia, Gonorrhea, Trichomonas, and Mycoplasma genitalium. This regulatory approval provides a new revenue opportunity for OraSure's DNA Genotek subsidiary and expands access to critical diagnostics. The news comes after the company reported a 7% year-over-year revenue decline and increased net losses in Q1 2026, making this a significant positive product development.
At the time of this announcement, OSUR was trading at $4.15 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $277.5M. The 52-week trading range was $2.08 to $4.33. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: GlobeNewswire.