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Roche Gets 510(k) Clearance, CLIA Waiver for Liat Triplex Point-of-Care STI Test

NEW YORK – Roche announced Wednesday that it has obtained 510(k) clearance and CLIA waiver from the US Food and Drug Administration for a point-of-care assay to detect and differentiate chlamydia, gonorrhea, and mycoplasma infections.

Using the Cobas Liat PCR system, the 20-minute CT/NG/MG test detects Chlamydia trachomatis, Neisseria gonorrhoeae, and Mycoplasma genitalium from a single sample.

The majority of the 1 million sexually transmitted infections acquired daily by people ages 15 to 49 are asymptomatic, according to the World Health Organization, and untreated STIs can lead to complications such as pelvic inflammatory disease and increased risk of HIV infection.

CLIA waiver now enables the CT/NG/MG molecular test to be used as part of a test-to-treat approach, Roche said in a statement, in locations such as retail clinics and urgent care centers. Testing at the point of care can also help reduce unnecessary antibiotic usage, facilitate targeted treatment strategies, improve healthcare efficiency and cost, and enhance short- and long-term health outcomes for patients, Roche added.

"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," Roche Diagnostics CEO Matt Sause said.

The firm previously obtained clearance and CLIA waiver for Liat assays to detect CT/NG alone, as well as for targets such as SARS-CoV-2, influenza A, influenza B, and strep A, while its Liat Clostridioides difficile test is cleared for use in by labs authorized under CLIA to perform moderately complex testing.

Its Liat assay to detect SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus was granted Emergency Use Authorization in June, and assays for other infectious diseases are currently in development, Roche said.

The CT/NG/MG test will be available exclusively in the US in the coming months, Roche said, with commercialization under CE marking to follow.