Roche’s point-of-care system approved for STI testing

SWITZERLAND – Roche has secured key U.S. regulatory approvals, enabling its cobas liat point-of-care testing system to screen for multiple sexually transmitted infections (STIs) using a single patient sample.

The system received 510(k) clearance from the FDA, along with a Clinical Laboratory Improvement Amendments (CLIA) waiver, allowing the tests to be conducted outside traditional laboratories in settings like urgent care centers, retail clinics, and pharmacies.

The cobas liat system, powered by PCR-based technology, delivers results within 20 minutes. Roche Diagnostics CEO Matt Sause stated, “Rapid molecular point-of-care testing can revolutionize the clinical management of STIs in decentralized and community-based healthcare settings, enabling informed treatment strategies, better health outcomes for patients, and containing further spread by providing timely diagnosis.”

By offering rapid results, the system can help healthcare providers initiate timely treatment before patients leave the clinic.

This eliminates the need for follow-up appointments, which many patients fail to attend, and can potentially reduce unnecessary antibiotic prescriptions.

The FDA approvals include panels for detecting chlamydia, gonorrhea, and Mycoplasma genitalium—a lesser-known but emerging pathogen affecting both men and women.

Roche emphasized the global burden of STIs, estimating that over 1 million new infections occur daily, with many cases showing no symptoms.

The cobas liat STI panels are set to launch in the U.S. in the coming months, while Roche seeks CE Mark approval for their use in Europe.

Beyond STI testing, the cobas liat system has been approved for point-of-care testing of SARS-CoV-2, influenza A and B, strep throat, and in-lab testing of Clostridium difficile (C. diff).