Roche's cobas liat molecular tests for chlamydia, gonorrhea, and Mycoplasma genitalium provide fast, accurate diagnoses in under 20 minutes.
Roche has received FDA clearance for its cobas liat molecular assays, designed to diagnose sexually transmitted infections (STIs) at the point of care. The tests, which have also been granted a Clinical Laboratory Improvement Amendments (CLIA) waiver, can rapidly detect multiple STIs, including chlamydia, gonorrhea, and Mycoplasma genitalium, with results available in just 20 minutes.1
This new FDA clearance is expected to improve access to accurate, fast diagnostics in decentralized settings such as urgent care centers, retail clinics, and community health venues. The tests provide healthcare professionals with the ability to diagnose and treat patients in a single visit, potentially reducing the spread of STIs and improving patient outcomes.1
More than 1 million STIs are acquired every day worldwide, with many cases being asymptomatic, especially among people aged 15–49 years.2 Early and accurate diagnosis is critical to prevent severe health complications, including pelvic inflammatory disease, infertility, and an increased risk of HIV infection. By leveraging PCR (polymerase chain reaction) technology, the cobas liat tests offer highly sensitive detection, helping healthcare providers to quickly identify infections and initiate treatment.
Roche’s point-of-care assays are designed to be easy to use and require minimal training, making them suitable for use in a wide range of healthcare settings. The tests can detect chlamydia and gonorrhea with a single sample (CT/NG), while the expanded CT/NG/MG test also includes Mycoplasma genitalium, an emerging pathogen that can lead to serious reproductive health issues if left untreated.3
Roche's CEO of Diagnostics, Matt Sause, highlighted the significance of these rapid molecular tests in improving the clinical management of STIs in community-based healthcare settings. “Rapid molecular point-of-care testing can revolutionize the clinical management of STIs in decentralized and community-based healthcare settings, enabling informed treatment strategies and better health outcomes,” Sause said.1
Roche's cobas liat STI tests, cleared by the FDA with a CLIA waiver, provide results in under 20 minutes for rapid diagnosis at the point of care.
The tests help diagnose multiple sexually transmitted infections, including chlamydia, gonorrhea, and Mycoplasma genitalium.
These point-of-care assays are designed to be easy to use with minimal training, making them ideal for urgent care centers, retail clinics, and community health settings.
The tests are expected to play a role in reducing loss-to-follow-up rates, a common issue in STI management. By facilitating immediate treatment, the tests can also help curb unnecessary antibiotic use, improve healthcare efficiency, and target specific pathogens, which is important in combatting antibiotic resistance.1
Overall, Roche’s cobas liat system provides rapid, accurate results in under 20 minutes using PCR technology, ensuring reliable diagnoses in various near-patient settings. Roche plans to expand the system's availability following FDA clearance with a growing portfolio of tests, including for SARS-CoV-2, influenza, and Strep A.
