FDA Clears Home Urine Collection Kit for STI Testing
MDSpire News
June 11, 2026
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The FDA has cleared the Colli-Pee Dx Urine Collection Kit for at-home STI testing using Roche assays.
The kit allows collection of first-void urine specimens for detecting Chlamydia, Gonorrhea, Trichomonas, and Mycoplasma.
It incorporates NucleoPrecision Technology to stabilize DNA and RNA in urine specimens at ambient temperatures.
Health care providers can prescribe the kit, enabling direct mail-in specimen collection for laboratory testing.
OraSure Technologies aims to enhance user-friendly testing options in decentralized settings with this innovation.
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