OraSure Technologies Inc. (NASDAQ: OSUR) announced that the U.S. Food and Drug Administration cleared its Colli-Pee™•Dx Urine Collection Kit for at-home sample collection to test for sexually transmitted infections.

The clearance allows the kit to be used with Roche's tests for Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium on Roche's cobas® 5800, 6800, and 8800 molecular diagnostic systems. The kit supports at-home self-collection of first-void urine samples for both male and female patients.

The collection kit includes NucleoPrecision™ Technology, which the company describes as proprietary chemistry for DNA and RNA stabilization. The technology allows urine samples to maintain integrity at ambient temperatures, enabling patients to collect samples at home and mail them to laboratories.

"This clearance connects people to care that is more accessible, convenient, private, and personalized," said Carrie Eglinton Manner, President and Chief Executive Officer of OraSure.

The kit is designed to collect volumetric, first-void urine while maintaining optimal sample-to-preservative ratio for STI detection. Healthcare providers can prescribe the collection kits, and laboratories can process the self-collected specimens using Roche's automated laboratory platforms.

OraSure subsidiary DNA Genotek will sell the Colli-Pee™•Dx Urine Collection Kit. The clearance enables laboratories and health systems to deploy mail-in workflows for molecular STI testing without requiring patients to visit healthcare facilities for sample collection.

Information in this article is based on the company's press release statement.