Roche transforms mass spectrometry diagnostics with launch of cobas® Mass Spec solution
Roche has received CE mark approval for its cobas® Mass Spec solution, including the cobas® i 601 analyser and first Ionify® reagent pack for steroid hormone testing. This launch marks a significant advancement in clinical mass spectrometry diagnostics, making it accessible to routine laboratories worldwide.
The solution will expand to offer more than 60 analytes for testing steroid hormones, vitamin D metabolites, immunosuppressant drugs, therapeutic drug monitoring, and drugs of abuse testing. The technology provides enhanced sensitivity and specificity, considered the diagnostic 'gold standard' for various clinical situations.
The system integrates with Roche's cobas® pro solutions, offering full automation and standardization, addressing previous limitations of mass spectrometry testing that required specialist laboratories and highly skilled operators.
Roche ha ricevuto l'approvazione del marchio CE per la sua soluzione cobas® Mass Spec, inclusi l'analizzatore cobas® i 601 e il primo pacchetto di reagenti Ionify® per il test degli ormoni steroidei. Questo lancio segna un significativo avanzamento nella diagnostica clinica della spettrometria di massa, rendendola accessibile ai laboratori di routine a livello mondiale.
La soluzione si espanderà per offrire più di 60 analiti per il test degli ormoni steroidei, dei metaboliti della vitamina D, dei farmaci immunosoppressori, del monitoraggio terapeutico dei farmaci e dei test per sostanze stupefacenti. Questa tecnologia fornisce una sensibilità e specificità migliorate, considerata il 'gold standard' diagnostico per varie situazioni cliniche.
Il sistema si integra con le soluzioni cobas® pro di Roche, offrendo automazione e standardizzazione complete, affrontando le limitazioni precedenti del test di spettrometria di massa che richiedevano laboratori specialistici e operatori altamente qualificati.
Roche ha recibido la aprobación de marca CE para su solución cobas® Mass Spec, que incluye el analizador cobas® i 601 y el primer paquete de reactivos Ionify® para pruebas de hormonas esteroides. Este lanzamiento marca un avance significativo en el diagnóstico clínico mediante espectrometría de masas, haciéndolo accesible a laboratorios de rutina en todo el mundo.
La solución se expandirá para ofrecer más de 60 analitos para pruebas de hormonas esteroides, metabolitos de vitamina D, medicamentos inmunosupresores, monitoreo terapéutico de medicamentos y pruebas de drogas de abuso. Esta tecnología proporciona una sensibilidad y especificidad mejoradas, considerada el 'estándar dorado' diagnóstico para diversas situaciones clínicas.
El sistema se integra con las soluciones cobas® pro de Roche, ofreciendo total automatización y estandarización, abordando las limitaciones anteriores de las pruebas de espectrometría de masas que requerían laboratorios especializados y operadores altamente capacitados.
로슈는 cobas® Mass Spec 솔루션에 대한 CE 마크 승인을 받았습니다. 여기에는 cobas® i 601 분석기 및 스테로이드 호르몬 테스트를 위한 첫 번째 Ionify® 시약 패키지가 포함됩니다. 이 출시로 인해 임상 질량 분석 진단에서 중요한 발전이 이루어졌으며, 전 세계의 일상 실험실로 하여금 접근 가능하게 되었습니다.
이 솔루션은 스테로이드 호르몬, 비타민 D 대사체, 면역억제제, 치료약물 모니터링 및 약물 남용 테스트를 위한 60개 이상의 분석물을 제공하기 위해 확장될 것입니다. 이 기술은 향상된 민감도와 특이성을 제공하며, 다양한 임상 상황에서 진단 '골드 스탠다드'로 여겨집니다.
이 시스템은 로슈의 cobas® pro 솔루션과 통합되어 완전한 자동화와 표준화를 제공하며, 전문 실험실과 고도로 숙련된 운영자가 필요했던 질량 분석 테스트의 이전 한계를 해결하고 있습니다.
Roche a obtenu l'approbation du marquage CE pour sa solution cobas® Mass Spec, y compris l'analyseur cobas® i 601 et le premier pack de réactifs Ionify® pour les tests hormonaux stéroïdiens. Ce lancement marque un progrès important dans le diagnostic clinique par spectrométrie de masse, le rendant accessible aux laboratoires de routine du monde entier.
La solution s'étendra pour offrir plus de 60 analytes pour les tests des hormones stéroïdiennes, des métabolites de la vitamine D, des médicaments immunosuppresseurs, le suivi thérapeutique des médicaments et les tests de drogues. La technologie offre une sensibilité et une spécificité améliorées, considérées comme le 'gold standard' diagnostique pour diverses situations cliniques.
Le système s'intègre aux solutions cobas® pro de Roche, offrant une automatisation et une standardisation complètes, répondant aux limitations antérieures des tests de spectrométrie de masse qui nécessitaient des laboratoires spécialisés et des opérateurs hautement qualifiés.
Roche hat die CE-Zulassung für seine cobas® Mass Spec-Lösung erhalten, einschließlich des cobas® i 601-Analysators und des ersten Ionify®-Reagenzienpakets zur Testung von Steroidhormonen. Diese Markteinführung stellt einen bedeutenden Fortschritt in der klinischen Massenspektrometrie-Diagnostik dar und macht sie für Routine-Labore weltweit zugänglich.
Die Lösung wird erweitert, um mehr als 60 Analyte für die Testung von Steroidhormonen, Vitamin D-Metaboliten, immunsuppressiven Medikamenten, therapeutischem Arzneimittelmonitoring und Drogenmissbrauchstests anzubieten. Die Technologie bietet eine verbesserte Empfindlichkeit und Spezifität, die als diagnostischer 'Goldstandard' für verschiedene klinische Situationen angesehen wird.
Das System integriert sich mit den cobas® pro-Lösungen von Roche und bietet vollständige Automatisierung und Standardisierung, wodurch frühere Einschränkungen der Massenspektrometrie-Tests, die spezialisierte Labore und hochqualifizierte Bediener erforderten, beseitigt werden.
- CE mark approval received for cobas® Mass Spec solution
- Planned expansion to over 60 analytes across multiple testing categories
- Integration with existing cobas® pro solutions enhancing laboratory efficiency
- New proprietary chemistry technology enabling commercial automation
- Environmental sustainability improvements over current methods
- None.
- Roche launches its cobas® Mass Spec solution, bringing mass spectrometry to the routine clinical lab
- Clinical mass spectrometry testing offers unparalleled sensitivity and specificity, providing clinicians with additional diagnostic insights1
- cobas Mass Spec solution will offer a fully automated, integrated and standardised workflow with IVDR-compliant assays
Basel, 18 December 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received CE mark approval for its cobas® Mass Spec solution including the cobas® i 601 analyser and the first Ionify® reagent pack of four assays for steroid hormones2. The CE mark is the first milestone in the global launch of the cobas Mass Spec solution, using in-house innovation to bring automated, integrated and standardised clinical mass spectrometry testing to routine laboratories worldwide. Following launch, the cobas Mass Spec solution will roll out a menu offering of more than 60 analytes for testing of steroid hormones, vitamin D metabolites, immunosuppressant drugs (ISD), therapeutic drug monitoring (TDM) and drugs of abuse testing (DAT).
“The cobas Mass Spec solution will fundamentally change the field of clinical diagnostics,” said Matt Sause, CEO of Roche Diagnostics. “The solution would make fully standardised clinical mass spectrometry more broadly available with the potential to improve patient care worldwide. For example, in breast cancer patients receiving hormone therapy, mass spectrometry can help physicians detect subtle changes in therapeutic response earlier, allowing for timely adjustments to treatment.”
The high specificity, sensitivity and accuracy of mass spectrometry is considered the diagnostic ‘gold standard’ for various clinical situations, for example measurements of steroid hormones in endocrinology, vitamin D testing, the monitoring of immunosuppressants and therapeutic drugs. Examples of how mass spectrometry can benefit healthcare systems include the effective and responsible use of antibiotics and ongoing monitoring of disease progression and treatment. The high specificity of testing can provide greater levels of clarity to physicians, enabling more timely treatment decisions for patients.
New, proprietary chemistry technology developed by Roche makes commercial automation possible, with a workflow that is much more environmentally sustainable than current methods. Until now, mass spectrometry has only been offered by specialist laboratories due to the low level of automation, integration and standardisation and the high complexity of the workflows that require highly skilled operators. This has resulted in great variability between different laboratories and long processing times.
The cobas Mass Spec solution will be part of Roche’s established cobas® pro integrated solutions which allows for full integration into clinical chemistry and immunochemistry testing as well as lab automation and IT.
For more information, please visit diagnostics.roche.com/MassSpec
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] Hristova, J., & Svinarov, D. (2022). Enhancing precision medicine through clinical mass spectrometry platform. Biotechnology & Biotechnological Equipment, 36(1), 107–117. https://doi.org/10.1080/13102818.2022.2053342
[2] Notified Body 0123
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