Roche achieves first CLIA 'Moderate Complexity' categorization for Ionify® 25-Hydroxy Vitamin D total test
Roche (OTCQX: RHHBY) has achieved a significant milestone as its Ionify® 25-Hydroxy Vitamin D total assay becomes the first mass spectrometry-based test to receive CLIA 'Moderate Complexity' designation from the FDA. The test runs on the cobas® i 601 analyzer, part of the cobas® Mass Spec solution.
This breakthrough enables broader access to advanced testing across routine clinical laboratories, moving beyond traditionally specialized labs. The system offers a fully automated, standardized workflow that combines mass spectrometry's sensitivity with improved efficiency. This is the first in Roche's planned U.S. pipeline for the cobas® Mass Spec solution, with additional launches expected globally.
Roche (OTCQX: RHHBY) ha raggiunto una tappa significativa poiché il suo Ionify® 25-Hydroxy Vitamin D total assay diventa il primo test basato sulla spettrometria di massa a ricevere la designazione CLIA 'Moderate Complexity' da parte della FDA. Il test viene eseguito sul cobas® i 601 analyzer, parte della cobas® Mass Spec solution.
Questo breakthrough consente un accesso più ampio ai test avanzati tra i laboratori clinici di routine, superando le tradizionali lab specializzate. Il sistema offre un flusso di lavoro completamente automatizzato e standardizzato che combina la sensibilità della spettrometria di massa con una maggiore efficienza. Questo è il primo della pipeline prevista di Roche negli Stati Uniti per la cobas® Mass Spec solution, con ulteriori lanci previsti a livello globale.
Roche (OTCQX: RHHBY) ha alcanzado un hito significativo ya que su ensayo Ionify® 25-Hydroxy Vitamin D total se convierte en la primera prueba basada en espectrometría de masas en recibir la designación de 'Moderate Complexity' de CLIA por parte de la FDA. La prueba se ejecuta en el cobas® i 601 analyzer, parte de la cobas® Mass Spec solution.
Este avance permite un acceso más amplio a pruebas avanzadas en laboratorios clínicos de rutina, yendo más allá de los laboratorios tradicionalmente specialized. El sistema ofrece un flujo de trabajo totalmente automatizado y estandarizado que combina la sensibilidad de la espectrometría de masas con una mayor eficiencia. Este es el primero de la pipeline prevista de Roche para los EE. UU. para la cobas® Mass Spec solution, con lanzamientos adicionales previstos a nivel mundial.
Roche (OTCQX: RHHBY) 의 Ionify® 25-Hydroxy Vitamin D 총 분석이 FDA로부터 'Moderate Complexity' 등급을 받은 최초의 질량분석 기반 검사로 중요한 이정표를 달성했습니다. 이 테스트는 cobas® i 601 분석기에서 실행되며 cobas® Mass Spec 솔루션의 일부입니다. 이 돌파구는 일상적인 임상 실험실에서도 고급 검사에 더 넓은 접근을 가능하게 하며, 전통적으로 전문적인 연구소를 넘어서게 합니다. 시스템은 질량분석의 민감도를 표준화된 자동 워크플로우와 결합한 완전 자동화된 워크플로우를 제공합니다. Roche의 cobas® Mass Spec 솔루션 미국 파이프라인의 첫 출시로, 전 세계적으로 추가 출시가 기대됩니다.
Roche (OTCQX: RHHBY) a franchi une étape importante alors que son test Ionify® 25-Hydroxy Vitamin D total devient le premier test basé sur la spectrométrie de masse à obtenir la désignation CLIA 'Moderate Complexity' de la FDA. Le test s'exécute sur l'analyseur cobas® i 601, faisant partie de la cobas® Mass Spec solution.
Cette avancée permet un accès plus large aux tests avancés dans les laboratoires cliniques de routine, allant au-delà des laboratoires traditionnellement spécialisés. Le système propose un flux de travail entièrement automatisé et standardisé qui combine la sensibilité de la spectrométrie de masse avec une meilleure efficacité. Ceci est le premier élément de la pipeline américaine prévue par Roche pour la cobas® Mass Spec solution, avec d'autres lancements attendus dans le monde.
Roche (OTCQX: RHHBY) hat einen bedeutenden Meilenstein erreicht, da sein Ionify® 25-Hydroxy Vitamin D total assay zum ersten mal ein massenspektrometriebasiertes Testverfahren die CLIA-Deklaration 'Moderate Complexity' von der FDA erhält. Der Test läuft auf dem cobas® i 601 Analyzer, Teil der cobas® Mass Spec-Lösung.
Dieser Durchbruch ermöglicht einen breiteren Zugang zu fortschrittlichen Tests in routinemäßigen klinischen Laboren, jenseits traditionell spezialisierter Labors. Das System bietet einen vollständig automatisierten, standardisierten Arbeitsablauf, der die Empfindlichkeit der Massenspektrometrie mit verbesserter Effizienz kombiniert. Dies ist der erste Schritt in Roches geplanter US-Pipeline für die cobas® Mass Spec-Lösung, mit weiteren Markteinführungen weltweit zu erwarten.
روش (OTCQX: RHHBY) حققت خطوة مهمة حيث أصبح اختبار Ionify® 25-Hydroxy Vitamin D total الاختبار الأول القائم على قياس الطيف الكتلي الذي يحصل على تصنيف CLIA «Moderate Complexity» من إدارة الغذاء والدواء الأمريكية. الاختبار يعمل على جهاز cobas® i 601، وهو جزء من cobas® Mass Spec solution. هذا الاختراق يتيح وصولاً أوسع إلى الاختبارات المتقدمة في مختبرات العيادات الروتينية، متجاوزاً المختبرات التقليدية المتخصصة. يوفر النظام تدفق عمل آلياً بالكامل وموحداً يجمع بين حساسية قياس الطيف الكتلي وكفاءة محسّنة. هذا هو الأول ضمن خط Roche المخطط له في الولايات المتحدة لـ cobas® Mass Spec solution، مع توقع إطلاقات إضافية على مستوى العالم.
Roche (OTCQX: RHHBY) 取得了一个重要里程碑，其 Ionify® 25-Hydroxy Vitamin D 总量分析 成为首个基于质谱的检测方法获得 FDA 的 CLIA “Moderate Complexity” 认证。该检测在 cobas® i 601 分析仪 上运行，属于 cobas® Mass Spec 解决方案的一部分。这一突破使日常临床实验室也能更广泛地开展高端检测，超越传统的专业实验室。系统提供一个完全自动化、标准化的工作流程，结合质谱的灵敏度与更高的效率。这是 Roche 计划在美国推出的 cobas® Mass Spec 解决方案流水线中的第一款，全球还将有更多上市。
- First mass spectrometry-based test to achieve CLIA 'Moderate Complexity' designation
- Expands access to advanced testing beyond specialized labs
- Offers standardized, automated workflow reducing variability across labs
- First of planned pipeline for cobas® Mass Spec solution in U.S.
- None.
- First mass spectrometry-based test system for total 25-Hydroxyvitamin D to receive CLIA 'Moderate Complexity' designation in the
U.S. - Expands access to advanced testing with a fully automated, standardized workflow on the cobas® i 601 analyzer
- Marks an important step in broadening the clinical utility of mass spectrometry testing across routine labs
The assay runs on Roche's cobas® i 601 analyzer, part of the cobas® Mass Spec solution. By combining mass spectrometry's sensitivity and specificity with a standardized, easy-to-use workflow, the cobas® Mass Spec solution streamlines complex testing and reduces variability across labs. Traditionally, these tests have been confined to highly specialized labs due to complex workflows and the need for expert operators.
"Achieving this level of automation for a mass spectrometry assay is a breakthrough for routine diagnostics," said Brad Moore, President and CEO, Roche Diagnostics North America. "It will allow more labs to deliver highly accurate results efficiently, helping clinicians make better-informed decisions and ultimately improving patient care."
The Ionify 25-Hydroxy Vitamin D total assay is the first in Roche's planned
Roche's proprietary chemistry enables scalable automation with a workflow that is faster, more reproducible and more environmentally sustainable than conventional mass spectrometry methods. This reduces variability across labs and helps minimize the need for outsourcing advanced testing.
For more information, please visit go.roche.com/USMassSpec or visit Roche's booth at the upcoming Mass Spectrometry & Advances in the Clinical Lab (MSACL) Conference in
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Amy Lynn
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FAQ
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