BETHLEHEM, Pa.- Medical technology company OraSure has secured the go-ahead from the federal government for a new product that the company has called key to its future growth.
The Colli-Pee kit has secured clearance from the U.S. Food and Drug Administration (FDA), OraSure announced.
The kit, made by OraSure subsidiary DNA Genotek, is an at-home urine collection device. The FDA has cleared its use with molecular diagnostic systems from the company Roche to identify a number of sexually transmitted infections (STIs).
“This clearance connects people to care that is more accessible, convenient, private, and personalized. It showcases what’s possible when you design solutions around real-life patient behavior,” said Carrie Eglinton Manner, President and CEO of OraSure, in a news release.
Colli-Pee is one of two products for which OraSure submitted applications to the FDA at the end of 2025. The other is a rapid molecular self-test for the types of bacteria that cause the STIs Chlamydia and gonorrhoeae. That test is made by Sherlock Bioscienses, another subsidiary of OraSure.
OraSure, based in Bethlehem, has cited both devices as essential to the company’s return to growth in a post-COVID world. The company’s stock (NASDAQ: OSUR) has struggled in recent years, with shares dropping more than 57% since 2021.
But shares have shown some renewed vigor over the past month, after hovering near $3.00 or below since January of 2025. Shares were up more than 2% to $4.14 in early trading Thursday.