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2025-01-23| Trials & Approvals

Roche’s STI Test Clears FDA Potentially Becoming A Game-Changer for Fast, Accurate Diagnosis

by Denisse Sandoval
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Image source: Shutterstock

Roche announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance and a Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver for its cobas liat sexually transmitted infection (STI) multiplex assay panels. The panels detect and differentiate multiple STIs using a single sample. They include tests for chlamydia and gonorrhea (CT/NG) as well as a combined panel for chlamydia, gonorrhea, and Mycoplasma genitalium (CT/NG/MG). Roche plans to launch these tests exclusively in the U.S. in the coming months, with commercialization under the CE mark expected to follow.

Gold-Standard PCR Technology Enables Rapid Testing for CT/NG, CT/NG/MG, and Other Pathogens in Near-Patient Settings

The 510(k) clearance confirms that Roche’s cobas liat STI multiplex assay panels meet regulatory standards for safety and effectiveness by proving equivalence to an existing approved device. The CLIA waiver further certifies that these tests are simple to use and carry a low risk of error, allowing their use in non-laboratory settings like clinics and physician offices. These approvals make advanced STI diagnostics more accessible and efficient for patient care.

Each day, over 1 million people worldwide contract a STI. Many common STIs share overlapping symptoms and can often be asymptomatic, which complicates diagnosis when based solely on symptoms. Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) are among the most widespread STIs. Without treatment, these infections can lead to serious health issues, including pelvic inflammatory disease (PID), urethritis, ectopic pregnancy, infertility, and an elevated risk of HIV infection.

The cobas liat system uses gold-standard PCR technology to deliver results in 20 minutes or less. It allows healthcare providers to conduct molecular testing in various near-patient environments with minimal training, ensuring speed and reliability. The system’s CT/NG and CT/NG/MG assays complement other tests available, including assays for pathogens like SARS-CoV-2, influenza A, influenza B, Strep A, and C. diff.

“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 Roche Diagnostics.

STI Trends Highlight a 1.8 Percent Decline in Overall Cases but Show 48.2% in Youth 

The Centers for Disease Control and Prevention (CDC) reported over 2.4 million cases of syphilis, gonorrhea, and chlamydia diagnosed in 2023. This included more than 209,000 cases of syphilis, over 600,000 cases of gonorrhea, and more than 1.6 million cases of chlamydia. Despite a 1% increase in syphilis cases, the overall STI rate decreased by 1.8% compared to 2022, driven by a 7.2% decline in gonorrhea cases and stable chlamydia rates.

In 2023, adolescents and young adults aged 15 to 24 accounted for approximately 48.2% of reported cases of chlamydia, gonorrhea, and syphilis. Additionally, non-Hispanic Black or African American individuals, representing 12.6% of the U.S. population, accounted for 32.4% of all reported cases of chlamydia, gonorrhea, and primary and secondary (P&S) syphilis. 

“Individuals who are infected with an STI may not be aware of their infection but can transmit the infection to others and may go on to develop long term and potentially fatal outcomes including cancer, chronic pelvic pain, ectopic pregnancies, and infertility. STIs can also be transmitted vertically from mother to infant during pregnancy or at delivery with potential adverse consequences for the infant. Infection with one STI may also facilitate the transmission of other STIs, including HIV,” reported the World Health Organization.

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