Roche has obtained U.S. government green lights allowing its point-of-care testing system to be used to screen for multiple sexually transmitted infections from a single sample.
The company’s cobas liat system received a new 510(k) clearance from the FDA, as well as a waiver from CLIA mandates requiring that certain clinical tests be analyzed within a qualified laboratory.
According to Roche, that will allow the PCR-based platform and its multiplex STI assays to provide results in 20 minutes at urgent care centers, retail clinics, pharmacies and elsewhere.

“Rapid molecular point-of-care testing can revolutionise the clinical management of STIs in decentralised and community-based healthcare settings, enabling informed treatment strategies, better health outcomes for patients, and contain further spread by providing timely diagnosis,” Roche Diagnostics CEO Matt Sause said in a statement.
Specifically, the company said that testing at the point-of-care can help providers quickly guide patients into treatment before they leave the clinic—avoiding the need to follow-up and reschedule further appointments, which many patients do not do, while potentially reducing the prescription of unnecessary antibiotics.
The agency clearances cover screeners for chlamydia and gonorrhea, two of the most prevalent STIs—as well as a third bacterium, Mycoplasma genitalium, which Roche described as an emerging pathogen affecting both males and females.
The company also estimated that more than 1 million people worldwide acquire an STI each day, with most showing no symptoms. The cobas liat panels are set to launch in the U.S. during the coming months, while Roche pursues a CE Mark approval for their use in Europe.
The cobas liat system has also received point-of-care green lights for the COVID-19 virus SARS-CoV-2, plus influenza A, influenza B and strep throat, as well as an in-lab test for Clostridium difficile, or C. diff.