Roche receives FDA clearance, CLIA waiver, for cobas® liat tests to provide point of care diagnosis of STIs

Tests broaden access to accurate, easy-to-use diagnostics for patients in a decentralised setting

Roche has been granted US Food and Drug Administration (FDA) 510(k) clearance and a Clinical Laboratory Improvement Amendments 1988 (CLIA) waiver for its cobas® liat sexually transmitted infection (STI) multiplex assay panels.

These panels which include tests for chlamydia and gonorrhoea will assist in the diagnosis of STIs and can differentiate between different infections with a single sample. These tests will initially only be made available in the US market. Commercialisation for the European Union under the CE mark is expected to follow.

“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.” said Matt Sause, CEO Roche Diagnostics.

More than one million people worldwide acquire an STI every day. Common STIs often present overlapping symptoms but can frequently be asymptomatic, making diagnosis challenging, when relying solely on symptoms. 

Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) are among the most prevalent STIs. If untreated, these infections can lead to serious health complications, including pelvic inflammatory disease (PID), urethritis, ectopic pregnancy and infertility. Additionally, Mycoplasma genitalium (MG) is an emerging sexually transmitted pathogen affecting both males and females, with untreated infections resulting in severe health issues such as PID and infertility. 

The cobas® liat CT/NG and cobas® liat CT/NG/MG STI assay tests expand upon Roche’s existing portfolio of lab-level solutions to diagnose and address patients’ needs at point of care. The test-to-treat approach can help mitigate the high loss to follow-up rates that often occur with STIs, so making treatment more likely.

Testing at the point of care can also help reduce unnecessary antibiotic usage, facilitate targeted treatment, improve efficiency and cost in the healthcare system, and improve patients’ short- and long-term health outcomes.

The cobas® liat system uses polymerase chain reactions to provide results in under 20 minutes. Cobas® liat assays are CLIA waived*, which enable healthcare professionals to perform molecular testing ─ as thought in a laboratory ─ in a variety of near-patient settings with speed, reliability and minimal training.

It is a closed system which aims to reduce risk of contamination and to enhance reliability of results.

*C. diff has been cleared by the FDA for use by authorised laboratories under CLIA to perform moderate complexity testing.