Roche Secures FDA Nod and CLIA Waiver for cobas liat STI

Roche reported that the US Food and Drug Administration (FDA) has provided 510(k) clearance and a Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver for its cobas liat panels for multiplex testing of sexually transmitted infections (STIs). These panels allow clinicians to diagnose and distinguish between various STIs with one sample, including tests for chlamydia and gonorrhoea (CT/NG) as well as chlamydia, gonorrhoea, and Mycoplasma genitalium (CT/NG/MG). These tests will only be accessible in the US market in the next months, with commercial release under CE mark likely to occur soon after.

“Quick molecular point-of-care testing can transform the clinical management of STIs in decentralized and community-driven healthcare environments, allowing for informed treatment plans, improved patient health outcomes, and curbing further transmission by delivering prompt diagnoses,” stated Matt Sause, CEO of Roche Diagnostics.

Over 1 million individuals globally contract an STI daily. Common STIs frequently have similar symptoms and can often be asymptomatic, which makes diagnosis difficult when depending only on symptoms. Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) rank among the most common sexually transmitted infections (STIs). If not treated, these infections may result in severe health issues, such as pelvic inflammatory disease (PID), urethritis, ectopic pregnancy, infertility, and a heightened risk of HIV infection. Moreover, Mycoplasma genitalium (MG) is a newly recognized sexually transmitted pathogen impacting both men and women, where untreated infections can lead to serious health complications like PID and infertility.