FDA Clears Cobas Liat Assay Panels for Point-of-Care Diagnosis of Sexually Transmitted Infections

Roche has announced that the US Food and Drug Administration (FDA) granted 510(k) clearance and a Clinical Laboratory Improvement Amendments (CLIA) waiver for its cobas liat multiplex assay panels for sexually transmitted infections (STIs), according to a company news release.¹

These test panels allow clinicians to diagnose chlamydia, gonorrhea, and Mycoplasma genitalium from a single specimen, with results available in about 20 minutes.¹

“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 of Roche Diagnostics, said in a news release.¹

In an effort to address rising STI rates, the newly cleared and CLIA-waived cobas liat tests are designed to increase access to rapid polymerase chain reaction (PCR)–based diagnostics in decentralized settings, such as urgent care centers, retail clinics, and community health venues. Because these multiplex tests quickly differentiate among multiple pathogens, healthcare professionals can initiate targeted treatment before the patient leaves the clinic.¹

According to the World Health Organization, more than 1 million curable STIs are acquired every day among adults aged 15 to 49 years, with many infections remaining asymptomatic. Common pathogens such as Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) can lead to serious complications, including pelvic inflammatory disease (PID), infertility, ectopic pregnancy, and higher susceptibility to HIV if left untreated. Mycoplasma genitalium (MG) is emerging as another significant pathogen that can cause PID and infertility in both men and women.²

The cobas liat system uses a closed PCR platform, minimizing contamination risk while maintaining quick turnaround times. With FDA clearance and CLIA waiver, these STI assays join Roche’s existing near-patient molecular testing portfolio for pathogens such as SARS-CoV-2, influenza A/B, Streptococcus pyogenes, and Clostridioides difficile. Point-of-care testing for STIs may help reduce the loss of patient follow-up by facilitating same-visit treatment decisions, potentially diminishing further spread of infection and avoiding unnecessary antibiotic use.¹

The tests will be introduced to the US market in the coming months, Roche said in the statement.¹

References

1. Roche receives FDA clearance with CLIA waiver for cobas liat molecular tests to diagnose sexually transmitted infections at the point of care [press release]. Published January 22, 2025. Accessed January 23, 2025. https://www.roche.com/media/releases/med-cor-2025-01-22

2. World Health Organization. Sexually transmitted infections (STIs). Accessed January 21, 2025.