Roche launches the first test to use its breakthrough TAGS technology for high throughput, simultaneous detection of 12 respiratory viruses
Roche has launched the cobas® Respiratory flex test, the first to use its novel TAGS (Temperature-Activated Generation of Signal) technology. This groundbreaking technology enables the detection of up to 15 pathogens in a single PCR test, a significant improvement over the typical four results in current high-throughput analyzers.
The cobas Respiratory flex test can detect 12 common respiratory viruses, including influenza A, influenza B, RSV, and SARS-CoV-2. It offers flexibility for targeted testing, allowing clinicians to specify which pathogens to look for based on various factors. The test runs on the cobas 5800, 6800, and 8800 systems, providing fast and efficient detection without the need for hardware or software upgrades.
This innovation simplifies laboratory logistics, optimizes resource use, and has the potential to revolutionize high-throughput testing for infectious diseases in the future. The test is now available in countries accepting CE-mark, with FDA submission planned for Q4.
Roche ha lanciato il cobas® Respiratory flex test, il primo a utilizzare la sua nuova tecnologia TAGS (Temperature-Activated Generation of Signal). Questa tecnologia innovativa consente la rilevazione di fino a 15 patogeni in un unico test PCR, un notevole miglioramento rispetto ai tipici quattro risultati offerti dagli attuali analizzatori ad alto rendimento.
Il cobas Respiratory flex test può rilevare 12 virus respiratori comuni, tra cui influenza A, influenza B, RSV e SARS-CoV-2. Offre flessibilità per test specifici, consentendo ai medici di indicare quali patogeni cercare in base a vari fattori. Il test funziona sui sistemi cobas 5800, 6800 e 8800, fornendo una rilevazione rapida ed efficiente senza la necessità di aggiornamenti hardware o software.
Questa innovazione semplifica la logistica di laboratorio, ottimizza l'uso delle risorse e potrebbe rivoluzionare i test ad alto rendimento per le malattie infettive in futuro. Il test è già disponibile nei paesi che accettano il marchio CE, con una presentazione alla FDA prevista per il Q4.
Roche ha lanzado el cobas® Respiratory flex test, el primero en utilizar su nueva tecnología TAGS (Temperature-Activated Generation of Signal). Esta tecnología revolucionaria permite la detección de hasta 15 patógenos en una única prueba PCR, una mejora significativa en comparación con los típicos cuatro resultados que proporcionan los analizadores de alto rendimiento actuales.
El cobas Respiratory flex test puede detectar 12 virus respiratorios comunes, incluyendo influenza A, influenza B, RSV y SARS-CoV-2. Ofrece flexibilidad para pruebas específicas, permitiendo a los clínicos especificar qué patógenos buscar en función de varios factores. La prueba se realiza en los sistemas cobas 5800, 6800 y 8800, proporcionando una detección rápida y eficiente sin necesidad de actualizaciones de hardware o software.
Esta innovación simplifica la logística del laboratorio, optimiza el uso de recursos y tiene el potencial de revolucionar las pruebas de alto rendimiento para enfermedades infecciosas en el futuro. La prueba ya está disponible en los países que aceptan el marcado CE, con una presentación a la FDA planificada para el cuarto trimestre.
로슈는 새로운 TAGS (온도 활성화 신호 생성 기술)을 사용하는 첫 번째 코바스® 호흡기 유연 검사를 출시했습니다. 이 혁신적인 기술은 단일 PCR 검사에서 최대 15가지 병원체를 감지할 수 있게 하여 현재 고속 분석기에서 제공하는 일반적인 네 가지 결과에 비해 상당한 개선을 이루었습니다.
코바스 호흡기 유연 검사는 인플루엔자 A, 인플루엔자 B, RSV 및 SARS-CoV-2를 포함한 12가지 일반적인 호흡기 바이러스를 감지할 수 있습니다. 여러 요소에 따라 의료진이 어떤 병원체를 찾아볼지를 지정할 수 있어 타겟 테스트를 위한 유연성을 제공합니다. 코바스 5800, 6800, 8800 시스템에서 작동하며, 하드웨어 또는 소프트웨어 업데이트 없이 빠르고 효율적인 감지가 가능합니다.
이 혁신은 실험실 물류를 단순화하고 자원 사용을 최적화하며, 미래에 감염병에 대한 고속 테스트를 혁신할 잠재력을 가지고 있습니다. 이 테스트는 CE 마크를 수용하는 국가에서 현재 사용 가능하며, FDA 제출은 4분기 예정입니다.
Roche a lancé le cobas® Respiratory flex test, le premier à utiliser sa nouvelle technologie TAGS (Temperature-Activated Generation of Signal). Cette technologie révolutionnaire permet la détection de jusqu'à 15 pathogènes dans un seul test PCR, ce qui constitue une amélioration significative par rapport aux quatre résultats typiques des analyseurs à haut débit actuels.
Le test cobas Respiratory flex peut détecter 12 virus respiratoires courants, notamment l'influenza A, l'influenza B, le VRS et le SARS-CoV-2. Il offre une flexibilité pour les tests ciblés, permettant aux cliniciens de spécifier quels pathogènes rechercher en fonction de divers facteurs. Le test est compatible avec les systèmes cobas 5800, 6800 et 8800, offrant une détection rapide et efficace sans besoin de mises à jour matérielles ou logicielles.
Cette innovation simplifie la logistique des laboratoires, optimise l'utilisation des ressources et a le potentiel de révolutionner les tests à haut débit pour les maladies infectieuses à l'avenir. Le test est désormais disponible dans les pays acceptant le marquage CE, avec une soumission à la FDA prévue pour le quatrième trimestre.
Roche hat den cobas® Respiratory flex test eingeführt, den ersten, der die neuartige TAGS (Temperature-Activated Generation of Signal)-Technologie verwendet. Diese bahnbrechende Technologie ermöglicht die Erkennung von bis zu 15 Pathogenen in einem einzigen PCR-Test, was eine erhebliche Verbesserung gegenüber den typischen vier Ergebnissen in aktuellen Hochdurchsatz-Analysatoren darstellt.
Der cobas Respiratory flex test kann 12 gängige respiratorische Viren erkennen, darunter Influenza A, Influenza B, RSV und SARS-CoV-2. Er bietet Flexibilität für zielgerichtete Tests, indem er es Klinikern ermöglicht, die zu suchenden Pathogene basierend auf verschiedenen Faktoren zu spezifizieren. Der Test läuft auf den cobas 5800, 6800 und 8800 Systemen und bietet eine schnelle und effiziente Erkennung, ohne dass Hard- oder Software-Updates erforderlich sind.
Diese Innovation vereinfacht die Laborlogistik, optimiert den Ressourceneinsatz und hat das Potenzial, die Hochdurchsatz-Testung von Infektionskrankheiten in Zukunft zu revolutionieren. Der Test ist jetzt in Ländern erhältlich, die die CE-Kennzeichnung akzeptieren, mit einer geplanten FDA-Einreichung für das 4. Quartal.
- Launch of innovative TAGS technology enabling detection of up to 15 pathogens in a single PCR test
- Increased efficiency in detecting 12 common respiratory viruses simultaneously
- Flexibility for targeted testing based on various factors
- Compatibility with existing cobas 5800, 6800, and 8800 systems without hardware/software upgrades
- Potential to revolutionize high-throughput testing for infectious diseases
- CE-mark approval obtained, with FDA submission planned for Q4
- None.
- New TAGS (Temperature-Activated Generation of Signal) technology enables up to 15 targets to be detected simultaneously in a single patient sample on the high throughput molecular diagnostic analysers cobas 5800, 6800 and 8800.
- TAGS has the potential to revolutionise testing for other infectious diseases in the future, by bringing high throughput customised syndromic panel testing to the routine clinical laboratory.
- The first TAGS-based test to be made available, the cobas Respiratory flex, offers fast, efficient detection of up to 12 of the most common respiratory viruses with the flexibility for targeted testing, expediting accurate diagnosis, optimising antimicrobial use and saving time in the lab.
Basel, 24 September 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the launch of the cobas® Respiratory flex test, the first to use Roche’s novel and proprietary TAGS (Temperature-Activated Generation of Signal) technology. TAGS technology, developed by Roche scientists, uses multiplex polymerase chain reaction (PCR) testing, combined with colour, temperature and data processing, to identify as many as 15 pathogens in a single PCR test. Typically, PCR tests on a high throughput analyser are able to identify four results in a single test - TAGS technology makes it possible to increase this number to fifteen. This will enable syndromic panel testing on the high throughput molecular diagnostic analysers cobas® 5800, 6800 and 8800, which is especially important when a common group of symptoms can be related to more than one pathogen.
“Many respiratory illnesses share similar symptoms, making them difficult to diagnose. As respiratory outbreaks, combined with growing incidence of antibiotic resistance continue, getting an accurate and timely diagnosis is critical to providing the best care for patients and curbing transmission,” said Matt Sause, CEO of Roche Diagnostics. “Using TAGS technology, the cobas Respiratory flex test can help clinicians identify specific respiratory viruses sooner, helping to speed up diagnosis and get the right care to patients.”
The cobas Respiratory flex test can detect up to 12 of the most common respiratory viruses, including influenza A, influenza B, Respiratory Syncytial Virus (RSV) and SARS-CoV-2, within a patient sample using a single PCR test. The test also allows clinicians to specify which pathogens to look for using pre-selected targets. With this, clinicians are able to factor in the test setting, season, locality and patient-specific factors. For example, a clinician might use a targeted test in the winter months to find out if a typically healthy adult patient has influenza or SARS-CoV-2 when those particular respiratory viruses are prevalent. Typically, when clinicians assess a certain group of targets first, diagnosis can be delayed if follow-up tests are needed. Through digital reflex, the cobas Respiratory flex test removes that delay by enabling the generation of additional results instantly or within seconds and without having to collect another sample or to run the existing sample again.
Delivering comprehensive results in a single PCR test, the cobas Respiratory flex test avoids the need for multiple test kits. This simplifies laboratory logistics, helping to optimise the use of resources and reduce pressure on labs. The test is now available in countries accepting CE-mark, and multiple countries around the world have initiated their local registrations. The U.S., 510(k) clearance from FDA will follow with submission planned for Q4. Additionally, the TAGS technology has potential across multiple types of pathogens and indications, offering the chance to revolutionise high throughput testing for infectious diseases in future.
TAGS (Temperature-Activated Generation of Signal) technology
Roche’s temperature-activated generation of signal (TAGS) technology, is introduced to differentiate up to three targets per fluorescence channel, enabling the detection and differentiation of up to 15 diagnostic results per well - all out of a single test kit. Roche’s new TAGS technology overcomes the technical limitations of a typical 4-plex test result in previous solutions, using a novel, proprietary approach. Without having to upgrade hardware or software in existing cobas 5800, 6800 and 8800 systems, labs will immediately be able to deliver fast, accurate, high throughput flexible syndromic multiplex PCR testing to central laboratories.
cobas Respiratory flex test
The cobas Respiratory flex test runs on the cobas 5800, 6800 and 8800 systems. The cobas Respiratory flex test offers qualitative detection and differentiation of Influenza A & B, Respiratory Syncytial Virus (RSV), Adenovirus (AdV), human Metapneumovirus (hMPV), Enterovirus/Rhinovirus (EV/RV), Parainfluenza 1, 2, 3 & 4, Coronavirus (229E, OC43, NL63, HKU1), and SARS-CoV-2 in nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection in conjunction with clinical and epidemiological risk factors.
Roche’s engagement in respiratory diagnostics
The launch of the cobas Respiratory flex test further strengthens Roche's comprehensive portfolio in respiratory diagnostics, which also includes the newly rebranded cobas® eplex system, a world-class solution for multiplex and syndromic testing. This launch also follows recent news that the FDA had granted Emergency Use Authorization for Roche’s four-in-one cobas® liat test for SARS-CoV-2, Influenza A/B & RSV enabling rapid, multiplex PCR diagnostic tests to be undertaken in emergency departments, urgent care facilities and physician office labs. Roche remains committed to offering a wide range of diagnostics solutions both for large laboratories and smaller, near-patient settings.
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.
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