FDA grants 510(k) clearance to cobas liat STI multiplex assay panels

FDA grants 510(k) clearance to cobas liat STI multiplex assay panels | Image Credit: © Araki Illustrations - © Araki Illustrations - stock.adobe.com.

The FDA has granted 510(k) clearance and Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver to the cobas liat sexually transmitted infection (STI) multiplex assay panels, according to Roche.¹

The clearance allows the panels to be available in US markets in the near future. Following this increase in availability, commercialization under CE mark is also expected. These panels will allow clinicians to differentiate between various STIs with a single sample.¹

“The tests use highly sensitive, gold-standard [polymerase chain reaction] technology, providing results in 20 minutes to allow health care providers to confidently diagnose and determine appropriate treatment in the same visit,” wrote Roche authors.¹

Over 1 million individuals aged 15 to 49 years experience curable STIs worldwide, with many cases being asymptomatic. Common STI types include Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG), but Mycoplasma genitalium (MG) is an emerging STI type that may lead to severe health issues.¹

Untreated STIs may lead to ectopic pregnancy, urethritis, infertility, pelvic inflammatory disease, and HIV infection. Using a test-to-treatment approach, clinicians can combat high rates of loss to follow-up, increasing the odds of treatment.¹

Tests for chlamydia and gonorrhea (CT/NG) and chlamydia, gonorrhea and Mycoplasma genitalium (CT/NG/MG) are included in the panels. These tests expand the options for diagnosing patient needs at the point of care, reducing the odds of unnecessary antibiotic use and facilitating targeted treatment strategies to improve patient outcomes.¹

“Rapid molecular point-of-care testing can revolutionize the clinical management of STIs in decentralized and community-based health care 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.¹

Point-of-care testing (POCT) has been linked to swift and accurate results, increasing patient satisfaction.² The 3 primary phases of POCT testing include pre-analytical, analytical, and post-analytical. During the pre-analytical phase, collection, transport, preparation, and loading are performed.

The analytical phase includes performances of a PCOT testing sequence. This is followed by the post-analytical phase, when the result is available.²

According to Michael C. Larkins and Aparna Thombare, affiliated with the East Carolina University Brody School of Medicine, POCT has high clinical significance because of its quick turnaround time. This method eliminates the need for sample transport, preventing procedure delays.²

As a closed system, the cobas liat system has a reduced risk of contamination, providing more accurate results.¹ The cobas liat CT/NG and CT/NG/MG assays include assays for pathogens such as SARS-CoV-2, influenza A, influenza B, Strep A, and C. diff.

The cobas liat system can connect to cobas infinity edge, allowing the assays to be easily added to the testing program. This also allows for remote schedule software and assay script updates and troubleshooting in all patient care settings. Roche is also developing assays for other infectious diseases.¹

According to Roche, the CLIA waver allows for “access to accurate, easy-to-use diagnostics for all patients in decentralized settings like urgent care centers, retail clinics, and community health venues.”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. F. Hoffmann-La Roche Ltd. January 22, 2025. Accessed January 22, 2025. https://www.globenewswire.com/news-release/2025/01/22/3013180/0/en/Roche-receives-FDA-clearance-with-CLIA-waiver-for-cobas-liat-molecular-tests-to-diagnose-sexually-transmitted-infections-at-the-point-of-care.html
2. Point-of-care testing. National Library of Medicine. Accessed January 22, 2025. https://www.ncbi.nlm.nih.gov/books/NBK592387/