OraSure Technologies (OSUR) has received US Food and Drug Administration clearance for its Colli-Pee Dx Urine Collection Kit for use with Roche molecular tests for chlamydia, gonorrhea, trichomoniasis and mycoplasma genitalium, the company said Thursday.
The clearance allows patients to self-collect urine samples at home or in other private settings for testing on Roche's molecular diagnostic systems, OraSure said.
The company said the kit uses its NucleoPrecision technology to stabilize DNA and RNA and maintain sample integrity at ambient temperatures.
Shares of the company were over 3% higher in Thursday premarket trading.