Roche receives FDA clearance with CLIA waiver for cobas® liat molecular tests to diagnose sexually transmitted infections at the point of care
Roche (RHHBY) has received FDA 510(k) clearance and CLIA waiver for its cobas® liat STI multiplex assay panels, enabling rapid diagnosis of multiple sexually transmitted infections from a single sample. The tests, which will be available in the U.S. market in coming months, can detect chlamydia, gonorrhea, and Mycoplasma genitalium.
The point-of-care tests utilize PCR technology and deliver results in 20 minutes, allowing healthcare providers to diagnose and treat patients in a single visit. This development is particularly significant as over 1 million people acquire curable STIs daily worldwide, with most cases being asymptomatic.
The tests will be initially launched in the U.S. market, with CE mark commercialization expected to follow. These solutions aim to improve healthcare efficiency, reduce unnecessary antibiotic usage, and enhance patient outcomes through immediate diagnosis and treatment.
Roche (RHHBY) ha ricevuto l'approvazione 510(k) della FDA e la deroga CLIA per i suoi pannelli di test multipli cobas® liat STI, che consentono una diagnosi rapida di più infezioni sessualmente trasmissibili da un unico campione. I test, disponibili nel mercato statunitense nei prossimi mesi, possono rilevare clamidiasi, gonorrea e Mycoplasma genitalium.
I test point-of-care utilizzano la tecnologia PCR e forniscono risultati in 20 minuti, permettendo ai fornitori di assistenza sanitaria di diagnosticare e trattare i pazienti in un'unica visita. Questo sviluppo è particolarmente significativo dato che oltre 1 milione di persone contraggono infezioni sessualmente trasmissibili curabili quotidianamente in tutto il mondo, con la maggior parte dei casi che rimangono asintomatici.
I test saranno inizialmente lanciati nel mercato statunitense, con la commercializzazione prevista del marchio CE in seguito. Queste soluzioni mirano a migliorare l'efficienza dell'assistenza sanitaria, ridurre l'uso non necessario di antibiotici e migliorare i risultati per i pazienti attraverso una diagnosi e un trattamento immediati.
Roche (RHHBY) ha recibido la aprobación 510(k) de la FDA y la exención CLIA para sus paneles de ensayo multiplex cobas® liat STI, lo que permite un diagnóstico rápido de múltiples infecciones de transmisión sexual a partir de una sola muestra. Las pruebas, que estarán disponibles en el mercado estadounidense en los próximos meses, pueden detectar clamidia, gonorrea y Mycoplasma genitalium.
Las pruebas en el punto de atención utilizan tecnología PCR y entregan resultados en 20 minutos, permitiendo a los proveedores de atención médica diagnosticar y tratar a los pacientes en una sola visita. Este desarrollo es particularmente significativo, ya que más de 1 millón de personas adquieren infecciones de transmisión sexual curables a diario en todo el mundo, siendo la mayoría de los casos asintomáticos.
Las pruebas se lanzarán inicialmente en el mercado estadounidense, y se espera que la comercialización con la marca CE siga. Estas soluciones buscan mejorar la eficiencia del sistema de salud, reducir el uso innecesario de antibióticos y mejorar los resultados para los pacientes a través de un diagnóstico y tratamiento inmediatos.
로슈 (RHHBY)는 FDA의 510(k) 승인을 받았으며 cobas® liat STI 다중검사 패널에 대해 CLIA 면제를 받았습니다. 이를 통해 단일 샘플로 여러 성병을 신속하게 진단할 수 있습니다. 이 검사는 향후 몇 달 내에 미국 시장에서 제공되며, 클라미디아, 임질, 마이코플라스마 유레아플라스마를 감지할 수 있습니다.
현장 검사에서는 PCR 기술을 활용하며 20분 만에 결과를 제공합니다. 이를 통해 의료 제공자는 단일 방문으로 환자를 진단하고 치료할 수 있습니다. 이 개발은 특히 중요합니다. 전 세계적으로 하루에 100만 명이 치료 가능한 성병에 감염되며, 대다수의 경우가 무증상입니다.
검사는 처음에 미국 시장에 출시될 예정이며, CE 마크 상업화가 뒤따를 것으로 예상됩니다. 이러한 솔루션은 의료의 효율성을 개선하고 불필요한 항생제 사용을 줄이며 즉각적인 진단과 치료를 통해 환자 결과를 향상시키는 것을 목표로 합니다.
Roche (RHHBY) a reçu l'approbation 510(k) de la FDA et l'exemption CLIA pour ses panneaux de tests multiplex cobas® liat STI, permettant un diagnostic rapide de plusieurs infections sexuellement transmissibles à partir d'un seul échantillon. Les tests, qui seront disponibles sur le marché américain dans les mois à venir, peuvent détecter la chlamydia, la gonorrhée et Mycoplasma genitalium.
Les tests au point de soin utilisent la technologie PCR et fournissent des résultats en 20 minutes, permettant aux professionnels de santé de diagnostiquer et de traiter les patients lors d'une seule visite. Ce développement est particulièrement significatif car plus de 1 million de personnes contractent quotidiennement des IST guérissables dans le monde, la plupart des cas étant asymptomatiques.
Les tests seront d'abord lancés sur le marché américain, la commercialisation avec marquage CE étant prévue par la suite. Ces solutions visent à améliorer l'efficacité des soins de santé, à réduire l'utilisation inutile d'antibiotiques et à améliorer les résultats des patients grâce à un diagnostic et un traitement immédiats.
Roche (RHHBY) hat die FDA-510(k)-Zulassung und die CLIA-Befreiung für seine cobas® liat STI Multiplex-Testpanels erhalten, die eine schnelle Diagnose mehrerer sexuell übertragbarer Infektionen aus einer einzigen Probe ermöglichen. Die Tests, die in den kommenden Monaten auf dem US-Markt verfügbar sein werden, können Chlamydien, Gonorrhöe und Mycoplasma genitalium nachweisen.
Die Point-of-Care-Tests nutzen die PCR-Technologie und liefern Ergebnisse in 20 Minuten, wodurch Gesundheitsdienstleister Patienten in einem einzigen Besuch diagnostizieren und behandeln können. Diese Entwicklung ist besonders bedeutend, da weltweit täglich über 1 Million Menschen heilbare STIs erwerben, wobei die meisten Fälle asymptomatisch sind.
Die Tests werden zunächst auf dem US-Markt eingeführt, und die Kommerzialisierung mit CE-Kennzeichnung wird voraussichtlich folgen. Diese Lösungen zielen darauf ab, die Effizienz im Gesundheitswesen zu verbessern, den unnötigen Antibiotikaeinsatz zu reduzieren und die Patientenergebnisse durch sofortige Diagnose und Behandlung zu verbessern.
- FDA 510(k) clearance and CLIA waiver obtained for new STI diagnostic tests
- Fast 20-minute result time enables same-visit diagnosis and treatment
- Expansion of diagnostic portfolio with point-of-care solutions
- Potential to reduce unnecessary antibiotic usage and healthcare costs
- None.
- More than 1 million curable sexually transmitted infections (STIs) are acquired every day worldwide in people 15–49 years old, most of which are asymptomatic.1
- FDA CLIA-waived tests broaden access to accurate, easy-to-use diagnostics for all patients in decentralized settings like urgent care centers, retail clinics, and community health venues.
- The tests use highly sensitive, gold-standard PCR technology, providing results in 20 minutes to allow healthcare providers to confidently diagnose and determine appropriate treatment in the same visit.
Basel, 22 January 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance and Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver for its cobas® liat sexually transmitted infection (STI) multiplex assay panels. These panels, including tests for chlamydia and gonorrhea (CT/NG) and chlamydia, gonorrhea and Mycoplasma genitalium (CT/NG/MG), enable clinicians to diagnose and differentiate between multiple STIs with a single sample. These tests will be exclusively available in the U.S. market in the coming months, with commercialisation under CE mark expected to follow shortly.
“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.
More than 1 million people worldwide acquire an STI every day. Common STIs often present overlapping symptoms and can frequently be asymptomatic, making diagnosis challenging, when relying solely on symptoms. Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) are among the most prevalent STIs. If untreated, these infections can lead to serious health complications, including pelvic inflammatory disease (PID), urethritis, ectopic pregnancy, infertility, and an increased risk of HIV infection.1 Additionally, Mycoplasma genitalium (MG) is an emerging sexually transmitted pathogen affecting both males and females, with untreated infections resulting in severe health issues such as PID and infertility.2
Comprehensive Point-of-Care Solutions
The cobas liat CT/NG and cobas liat CT/NG/MG STI assay tests further expand and complement Roche’s broad portfolio of lab-level solutions to help diagnose and address patients’ needs at the point of care. The test-to-treat approach can help combat potentially high loss to follow-up rates, making treatment more likely. Testing at the point of care can help reduce unnecessary antibiotic usage, facilitate targeted treatment strategies, improve healthcare efficiency and cost, and ultimately enhance the patients’ short and long-term health outcomes.3-5
About the cobas liat system
The cobas liat system utilises gold-standard PCR technology to provide results in 20 minutes or less. The cobas liat assays are CLIA waived*, enabling healthcare professionals to perform molecular testing in a variety of near-patient settings with speed, reliability and minimal training. The cobas liat system is a closed system, reducing contamination risks and enhancing the reliability of results. The cobas liat CT/NG and CT/NG/MG assays complement existing tests for the cobas liat system. These include singleplex and multiplex assays for a variety of pathogens such as SARS-CoV-2, influenza A, influenza B, Strep A., and C. diff. These assays are easily added to a testing programme 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. Assays for other infectious diseases are currently in development. The cobas liat system is commercially available in select markets.
*C. diff has been cleared by the FDA for use by authorised laboratories under CLIA to perform moderate complexity testing.
About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.
For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045.
Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.
For more information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected by law.
References
[1] Sexually transmitted infections key facts. World Health Organization. Published May 2024.
[2] Mycoplasma Genitalium: A New Superbug. NIH PubMed. Published June 7, 2022.
[3] Call to action for health systems integration of point of care testing to mitigate the transmission and burden of STI. NIH PubMed. Published August 2020.
[4] The rising importance of urgent care in the fight against the STI epidemic. Journal of Urgent Care Medicine. Published November 30, 2022.
[5] Point of Care Testing. NIH STATPEARLS. Published May 29, 2023.
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