Roche Wins FDA Nod, CLIA Waiver for STI Multiplex Panels

Roche has received U.S. Food and Drug Administration (FDA) 510(k) clearance and Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver for its cobas liat sexually transmitted infection (STI) multiplex assay panels.

The panels include tests for chlamydia and gonorrhea (CT/NG) and chlamydia, as well as gonorrhea and Mycoplasma genitalium (CT/NG/MG). They allow clinicians to diagnose and differentiate between multiple STIs with a single sample.

Roche said the tests will become available in the U.S. in the coming months, with commercialization under CE mark anticipated to closely follow.

“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 contain further spread by providing timely diagnosis,” said Matt Sause, CEO Roche Diagnostics.

The cobas liat CT/NG and cobas liat CT/NG/MG STI assay tests further expand and complement Roche’s broad portfolio of lab-level solutions to help diagnose and address patients’ needs at the point of care. The test-to-treat approach can help combat potentially high loss to follow-up rates, making treatment more likely.

In July 2024, gained CE mark clearance for its Accu-Chek SmartGuide continuous glucose monitoring (CGM) solution. It’s been cleared for adults with type 1 and type 2 diabetes on flexible insulin therapy.