New Molecular Tests Diagnose STIs at POC

Over one million people across the world catch a sexually transmitted infection (STI) every day. Common STIs usually present overlapping symptoms and can mostly be asymptomatic, making it challenging to achieve a diagnosis, when depending fully on symptoms. Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) are among the most common STIs. When left untreated, these infections can cause serious health complications, such as pelvic inflammatory disease (PID), urethritis, ectopic pregnancy, infertility, and a higher risk of HIV infection. Moreover, Mycoplasma genitalium (MG) is an upcoming sexually transmitted pathogen that affects males as well as females, with untreated infections leading to severe health issues like PID and infertility. Now, new FDA CLIA-waived tests can expand access to accurate, simple-to-use diagnostics for all patients in decentralized settings such as urgent care centers, retail clinics, and community health venues. The tests utilize highly sensitive, gold-standard PCR technology, generating results in 20 minutes to enable healthcare providers to confidently diagnose and arrive at the right treatment decision in the same visit.

Roche (Basel, Switzerland) has been granted 510(k) clearance and Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver by the U.S. Food and Drug Administration (FDA) for its cobas liat sexually transmitted infection (STI) multiplex assay panels. These panels, including tests for CT/NG and chlamydia, gonorrhea, and CT/NG/MG, allow clinicians to diagnose and differentiate between several STIs using a single sample. Over the coming months, these tests will be available exclusively in the U.S. market, followed by commercialization under the CE mark shortly. 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 reduce high loss to follow-up rates, ensuring treatment is more likely. Point-of-care testing can lower unnecessary antibiotic usage, aid targeted treatment strategies, enhance healthcare efficiency and cost, and improve the patients’ short and long-term health outcomes.

The cobas liat system, commercially available in select markets, uses gold-standard PCR technology to generate results in 20 minutes or less. The CLIA-waived cobas liat assays enable healthcare professionals to carry out molecular testing in various near-patient settings with speed, reliability, and minimal training. cobas liat is a closed system, lowering contamination risks and improving the reliability of results. The cobas liat CT/NG and CT/NG/MG assays complement existing tests for the cobas liat system. These include singleplex and multiplex assays for a variety of pathogens such as SARS-CoV-2, influenza A, influenza B, Strep A., and C. diff. These assays can be easily added to a testing program by connecting the cobas liat system to cobas infinity edge to schedule software and assay script updates remotely, and to offer remote troubleshooting across all patient-care settings. Connected cobas liat instruments streamline testing workflow and lower instrument maintenance time. Roche is also developing assays for other infectious diseases.

“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.

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