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A Single Sample Sexually Transmitted Infection System Receives FDA Clearance With CLIA Waiver
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Key Takeaways
- The cobas liat system offers rapid, point-of-care STI testing, providing results in under 20 minutes using PCR technology.
- FDA clearance and CLIA waiver enable near-patient testing with minimal training, improving accessibility and reliability.
The cobas liat system is a closed system that aims to reduce contamination risks and enhances the reliability of results at the point of care.
The FDA granted 510(k) clearance and Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver for the cobas liat (Roche Molecular Diagnostics) sexually transmitted infections (STI) multiplex assay panels. The panels will allow clinicians to test and diagnose different STIs with a single sample, including chlamydia and gonorrhea (CT/NG) and chlamydia, gonorrhea and Mycoplasma genitalium (CT/NG/MG).1
More than 1 million curable STIs are acquired daily in individuals aged 15 to 49 years through sexual contact, including vaginal, oral, and anal sex, according to the World Health Organization (WHO). Additionally, common STIs like chlamydia, gonorrhoea, syphilis, and trichomoniasis are often asymptotic or present similar symptoms of burning or itching in the genial area, which could make diagnosis an even greater challenge.2,3
In 2020, WHO estimated a total of 374 million new infections with 1 of the 4 STI—chlamydia, gonorrhoea, syphilis, and trichomoniasis.2
While the highlighted STIs are curable, if untreated the infections can have a direct impact on sexual and reproductive health, leading to pelvic inflammatory disease (PID), urethritis, ectopic pregnancy, infertility, and an increased risk of human immunodeficiency virus (HIV) infection. Additionally, MG, which is an STI that can affect both males and females could lead to PID and infertility if untreated.1,2
Despite the widespread use of accurate molecular STI diagnostic tests in high-income countries, mainly for asymptomatic infections, their limited availability, high cost, and slow turnaround times in low- and middle-income countries often delay timely diagnosis, treatment, and patient follow-up, impacting the effectiveness of STI care.2
STI testing typically involves a group of tests that check for different infections through samples of bodily fluid. The most common forms of STI testing include a blood test, urine test, oral swab, genital or rectal swab, and a physical exam.3 The cobas liat system would limit the number of tests needed, using gold-standard polymerase chain reaction (PCR) technology to provide tests results in 20 minutes or less.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.” Matt Sause, CEO of Roche Diagnostics, said in a news release.1
Implementing point-of-care testing for STIs can provide swift and appropriate treatment compared to traditional laboratory testing that involves a multiple step process.4 The test-to-treat approach can improve patient outcomes by increasing treatment likelihood while reducing unnecessary antibiotic use, enabling targeted therapies, and enhancing healthcare efficiency and cost-effectiveness, according to study authors.1
The study authors noted that the cobas liat system is a closed system that aims to reduce contamination risks and enhances the reliability of results. The cobas liat assays are CLIA waived which allows health care professionals to test in near-patient settings with minimal training, providing speedy and reliable results. Additionally, the cobas liat CT/NG and CT/NG/MG assays expand the cobas liat system's testing capabilities, complementing existing assays for various pathogens like SARS-CoV-2 and influenza.1
“These assays are easily added to a testing program by connecting the cobas liat system to cobas infinity edge to remotely schedule software and assay script updates, and to provide remote troubleshooting in all patient-care settings. Connected cobas liat instruments streamline testing workflow and reduce instrument maintenance time,” read the news release.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. Roche. News release, January 21, 2025. Accessed January 27, 2025. https://www.roche.com/media/releases/med-cor-2025-01-22
2. Sexually transmitted infections (STIs). World Health Organization. News release. May 21, 2024. Accessed January 27, 2025. https://www.who.int/news-room/fact-sheets/detail/sexually-transmitted-infections-(stis)
3. STI Testing (STD Testing). Cleveland Clinic. News release. December 1, 2023. Accessed January 27, 2025. https://my.clevelandclinic.org/health/diagnostics/std-testing
4. Larkins MC, Thombare A. Point-of-Care Testing. [Updated 2023 May 29]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK592387/
