Roche has received the US Food and Drug Administration (FDA) 510(k) approval for its cobas liat sexually transmitted infection (STI) multiplex assay panels.
The Swiss diagnostics company also secured the Clinical Laboratory Improvement Amendments (CLIA) waiver for the test panels.
The cobas liat STI panels include tests for chlamydia and gonorrhea (CT/NG) and chlamydia, gonorrhea, and Mycoplasma genitalium (CT/NG/MG).
With the STI panels, clinicians can diagnose and differentiate between multiple STIs, using a single sample.
Roche plans to exclusively distribute the tests in the US market, in a few months.
Roche Diagnostics CEO Matt Sause said: “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.”
According to Roche, common STIs often present overlapping symptoms and can be often asymptomatic, making symptoms-based diagnosis more challenging.
Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) are the most common STIs.
The infections can lead to serious complications, such as pelvic inflammatory disease (PID), urethritis, ectopic pregnancy, infertility, and elevated risk of HIV, if left untreated.
Mycoplasma genitalium (MG) is a new sexually transmitted pathogen affecting both males and females, resulting in severe health issues such as PID and infertility.
The cobas liat assay panels run on Roche’s cobas liat system, a closed system that uses gold-standard PCR technology to provide results within 20 minutes.
The cobas liat CT/NG and CT/NG/MG assays are compatible with existing tests for the cobas liat system, including SARS-CoV-2, influenza A, influenza B, Strep A., and C.
CLIA waiver enables healthcare professionals to quickly perform molecular testing in various near-patient settings with minimal training.
Roche said the cobas liat CT/NG and cobas liat CT/NG/MG STI assays further expand and complement its portfolio of lab-level point-of-care solutions.
