Agilent Companion Diagnostic Assay PD-L1 IHC 28-8 pharmDx Receives European IVDR Certification
Agilent Technologies (NYSE: A) has received Class C companion diagnostic In Vitro Diagnostic Regulation (IVDR) certification for its PD-L1 IHC 28-8 pharmDx assay in Europe. The assay, which works exclusively with Agilent's Autostainer Link 48 staining solution, helps identify PD-L1 expression, a important biomarker for response to anti-PD-1 antibody therapies like OPDIVO® and OpdualagTM.
The certification covers nine cancer indications, including five companion diagnostic indications: non-small cell lung cancer, muscle invasive urothelial carcinoma, melanoma, esophageal squamous cell carcinoma, and gastric/gastroesophageal junction/esophageal adenocarcinoma. This certification ensures continued uninterrupted access for EU laboratories using Agilent's diagnostic products.
Agilent Technologies (NYSE: A) ha ricevuto la certificazione per dispositivi diagnostici in vitro (IVDR) di classe C per il suo saggio PD-L1 IHC 28-8 pharmDx in Europa. Questo saggio, che funziona esclusivamente con la soluzione di colorazione Autostainer Link 48 di Agilent, aiuta a identificare l'espressione di PD-L1, un biomarker importante per la risposta alle terapie con anticorpi anti-PD-1 come OPDIVO® e OpdualagTM.
La certificazione copre nove indicazioni oncologiche, comprese cinque indicazioni diagnostiche companion: carcinoma polmonare non a piccole cellule, carcinoma uroteliale invasivo muscolare, melanoma, carcinoma squamoso esofageo e adenocarcinoma gastrico/giunzione gastroesofagea/esofagea. Questa certificazione garantisce un accesso continuo senza interruzioni per i laboratori dell'UE che utilizzano i prodotti diagnostici di Agilent.
Agilent Technologies (NYSE: A) ha recibido la certificación de diagnóstico companion de Clase C bajo la Regulación de Diagnóstico In Vitro (IVDR) para su ensayo PD-L1 IHC 28-8 pharmDx en Europa. El ensayo, que funciona exclusivamente con la solución de tinción Autostainer Link 48 de Agilent, ayuda a identificar la expresión de PD-L1, un biomarcador importante para la respuesta a las terapias con anticuerpos anti-PD-1 como OPDIVO® y OpdualagTM.
La certificación abarca nueve indicaciones oncológicas, incluyendo cinco indicaciones de diagnóstico companion: cáncer de pulmón no microcítico, carcinoma urotelial invasivo muscular, melanoma, carcinoma escamoso esofágico y adenocarcinoma gástrico/junción gastroesofágica/esofágico. Esta certificación asegura un acceso ininterrumpido para los laboratorios de la UE que utilizan los productos diagnósticos de Agilent.
Agilent Technologies (NYSE: A)는 유럽에서 PD-L1 IHC 28-8 pharmDx 검사를 위한 IVDR 규정에 따라 C급 동반 진단 인증을 받았습니다. 이 검사는 Agilent의 Autostainer Link 48 염색 솔루션과 독점적으로 작동하며, OPDIVO® 및 OpdualagTM와 같은 항 PD-1 항체 요법에 대한 반응의 중요한 바이오마커인 PD-L1 발현을 식별하는 데 도움을 줍니다.
인증은 9개의 암 적응증을 포함하며, 그 중 5개는 동반 진단 적응증입니다: 비소세포 폐암, 근육 침습성 요로 세포암, 흑색종, 식도 편평 세포암 및 위/위식도 교차점/식도 선암입니다. 이 인증은 Agilent의 진단 제품을 사용하는 EU 실험실이 중단 없는 지속적인 접근을 보장합니다.
Agilent Technologies (NYSE: A) a reçu la certification de diagnostic compagnon de classe C selon le règlement de diagnostic in vitro (IVDR) pour son essai PD-L1 IHC 28-8 pharmDx en Europe. Cet essai, qui fonctionne exclusivement avec la solution de coloration Autostainer Link 48 d'Agilent, aide à identifier l'expression de PD-L1, un biomarqueur important pour la réponse aux thérapies par anticorps anti-PD-1 comme OPDIVO® et OpdualagTM.
La certification couvre neuf indications de cancer, y compris cinq indications de diagnostic compagnon : le cancer du poumon non à petites cellules, le carcinome urothélial invasif musculaire, le mélanome, le carcinome épidermoïde de l'œsophage et l'adénocarcinome gastrique/jonction gastro-œsophagienne/œsophagien. Cette certification garantit un accès continu sans interruption pour les laboratoires de l'UE utilisant les produits diagnostiques d'Agilent.
Agilent Technologies (NYSE: A) hat die Zertifizierung als begleitende Diagnose der Klasse C gemäß der IVDR-Verordnung für seinen PD-L1 IHC 28-8 pharmDx-Test in Europa erhalten. Der Test, der ausschließlich mit der Färbelösung Autostainer Link 48 von Agilent arbeitet, hilft dabei, die PD-L1-Expression zu identifizieren, einen wichtigen Biomarker für die Reaktion auf Antikörpertherapien gegen PD-1 wie OPDIVO® und OpdualagTM.
Die Zertifizierung umfasst neun Krebsindikationen, darunter fünf begleitende Diagnoseindikationen: nicht-kleinzelliges Lungenkarzinom, muskelinvasives Urothelkarzinom, Melanom, Plattenepithelkarzinom des Ösophagus und Adenokarzinom des Magens/gastroösophagealen Übergangs/Ösophagus. Diese Zertifizierung gewährleistet einen ununterbrochenen Zugang für EU-Labore, die die diagnostischen Produkte von Agilent verwenden.
- Received European IVDR certification for PD-L1 IHC 28-8 pharmDx assay
- Certification covers nine cancer indications, expanding market reach
- Ensures continued access to EU market under new regulations
- None.
Insights
The IVDR certification for Agilent's PD-L1 IHC 28-8 pharmDx assay represents a significant regulatory milestone in the companion diagnostics landscape. This certification covers nine cancer indications, including five as companion diagnostics, notably for NSCLC, MIUC, melanoma, ESCC and gastric/GEJ cancers. The assay's ability to identify PD-L1 expression is important for predicting response to immunotherapy drugs like OPDIVO® and OpdualagTM.
The transition from CE-IVD marking to IVDR certification demonstrates compliance with more stringent regulatory requirements under the new EU framework. This certification ensures continued market access in the EU and validates the assay's reliability for healthcare providers. The Class C designation indicates the test's high-risk classification, reflecting its critical role in treatment decisions.
This regulatory achievement strengthens Agilent's position in the growing companion diagnostics market, particularly in the EU region. The IVDR certification maintains Agilent's competitive advantage in precision medicine diagnostics and ensures uninterrupted revenue streams from European laboratory customers. The broad range of cancer indications covered by the certification expands the assay's market potential, especially given the growing adoption of immunotherapy treatments.
The certification's timing is strategic, as it comes during the transition period to the new IVDR framework, positioning Agilent ahead of competitors who may still be working toward compliance. This regulatory success supports the company's long-term growth in the precision medicine diagnostics sector, particularly in partnership with major pharmaceutical companies like Bristol-Myers Squibb.
Agilent’s PD-L1 IHC 28-8 pharmDx (Code SK005) provides clinically relevant information about PD-L1 expression – a critical biomarker for potential response to therapies containing anti-PD-1 antibodies such as OPDIVO® (nivolumab) which has demonstrated therapeutic value across growing list of cancer types and OpdualagTM (nivolumab and relatimab).
PD-L1 IHC 28-8 pharmDx (Code SK005) has received European IVDR certification for nine cancer indications, including five companion diagnostic indications; non-small cell lung cancer (NSCLC), muscle invasive urothelial carcinoma (MIUC), melanoma, esophageal squamous cell carcinoma (ESCC), and gastric, gastroesophageal junction (GEJ) and esophageal adenocarcinoma.
Simon May, senior vice president of Agilent’s Life Sciences and Diagnostics Markets Group, commented on this important achievement: “The IVDR certification of PD-L1 IHC 28-8 pharmDx as a Class C-CDx device is critical to our CDx assays and enhances the confidence of healthcare professionals and patients in the EU by showing that these medical devices can be safely relied upon.”
Companion diagnostic (CDx) assays are medical devices used to help identify patients most likely to benefit from a specific drug treatment, thus offering key clinical support for the enablement of appropriate medicines. Access to IVDR-compliant CDx ensures that laboratories in the EU, who rely on Agilent products in their diagnostic workflows, can continue to use those products without disruption.
OPDIVO® is a registered trademark of Bristol-Myers Squibb Company; OpdualagTM is a trademark of Bristol-Myers Squibb Company.
1 Regulation (EU) 2017/746 In Vitro Diagnostic Medical Devices Regulation (europa.eu)
About Agilent Technologies
Agilent Technologies Inc. (NYSE: A) is a global leader in analytical and clinical laboratory technologies, delivering insights and innovation that help our customers bring great science to life. Agilent’s full range of solutions includes instruments, software, services, and expertise that provide trusted answers to our customers' most challenging questions. The company generated revenue of
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MEDIA CONTACT
Naomi Goumillout
Agilent Technologies
+1.978.314.1862
naomi.goumillout@agilent.com
Source: Agilent Technologies Inc.
FAQ
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