Agilent PD-L1 IHC 28-8 pharmDx Receives EU IVDR Certification as a Companion Diagnostic Test for Non-small Cell Lung Cancer and Melanoma Indications
Agilent Technologies (NYSE: A) has received EU IVDR certification for two new companion diagnostic indications for its PD-L1 IHC 28-8 pharmDx kit, bringing the total European indications to nine. The approvals expand treatment eligibility for:
1. Early-stage non-small cell lung cancer (NSCLC) patients with PD-L1 expression ≥1% at high recurrence risk, enabling treatment with OPDIVO® plus platinum-based chemotherapy
2. Previously untreated advanced melanoma patients (12+ years) with tumor cell PD-L1 expression <1%, enabling treatment with Opdualag™
The kit, exclusively used with Agilent's Autostainer Link 48, addresses significant healthcare concerns: lung cancer (2+ million new cases, 1.77 million deaths annually) and melanoma (324,000+ new cases, 57,000+ deaths annually). As the only clinically validated test for these treatments, it aids pathologists and oncologists in treatment selection.
Agilent Technologies (NYSE: A) ha ricevuto la certificazione EU IVDR per due nuove indicazioni diagnostiche companion per il suo kit PD-L1 IHC 28-8 pharmDx, portando il totale delle indicazioni europee a nove. Le approvazioni ampliano l'idoneità al trattamento per:
1. Pazienti con cancro polmonare non a piccole cellule (NSCLC) in stadio precoce con espressione di PD-L1 ≥1% ad alto rischio di recidiva, consentendo il trattamento con OPDIVO® più chemioterapia a base di platino.
2. Pazienti con melanoma avanzato precedentemente non trattati (12+ anni) con espressione di PD-L1 nelle cellule tumorali <1%, consentendo il trattamento con Opdualag™.
Il kit, utilizzato esclusivamente con l'Autostainer Link 48 di Agilent, affronta importanti preoccupazioni sanitarie: cancro ai polmoni (oltre 2 milioni di nuovi casi, 1,77 milioni di morti all'anno) e melanoma (oltre 324.000 nuovi casi, oltre 57.000 morti all'anno). Essendo l'unico test clinicamente convalidato per questi trattamenti, supporta i patologi e gli oncologi nella selezione del trattamento.
Agilent Technologies (NYSE: A) ha recibido la certificación EU IVDR para dos nuevas indicaciones de diagnóstico companion para su kit PD-L1 IHC 28-8 pharmDx, llevando el total de indicaciones europeas a nueve. Las aprobaciones amplían la elegibilidad para el tratamiento de:
1. Pacientes con cáncer de pulmón no microcítico (NSCLC) en etapa temprana con expresión de PD-L1 ≥1% y alto riesgo de recurrencia, permitiendo el tratamiento con OPDIVO® más quimioterapia basada en platino.
2. Pacientes con melanoma avanzado previamente no tratados (12+ años) con expresión de PD-L1 en células tumorales <1%, permitiendo el tratamiento con Opdualag™.
El kit, utilizado exclusivamente con el Autostainer Link 48 de Agilent, aborda preocupaciones importantes en salud: cáncer de pulmón (más de 2 millones de nuevos casos, 1.77 millones de muertes anuales) y melanoma (más de 324,000 nuevos casos, más de 57,000 muertes anuales). Siendo la única prueba clínicamente validada para estos tratamientos, ayuda a patólogos y oncólogos en la selección del tratamiento.
Agilent Technologies (NYSE: A)는 PD-L1 IHC 28-8 pharmDx 키트에 대해 두 가지 새로운 동반 진단 적응증에 대한 EU IVDR 인증을 받았으며, 이는 유럽의 적응증 총수를 아홉으로 늘립니다. 이번 승인은 다음과 같은 치료 자격을 확대합니다:
1. PD-L1 발현이 ≥1%인 고재발 위험의 초기 비소세포 폐암(NSCLC) 환자에게 OPDIVO®와 플래티넘 기반 화학요법으로 치료할 수 있게 합니다.
2. 종양 세포 PD-L1 발현이 <1%인 이전에 치료받지 않은 진행성 흑색종 환자(12세 이상)에게 Opdualag™로 치료할 수 있게 합니다.
이 키트는 Agilent의 Autostainer Link 48과 독점적으로 사용되며, 중요한 건강 문제를 다룹니다: 폐암(연간 200만 건 이상의 신규 사례, 177만 건의 사망) 및 흑색종(연간 324,000건 이상의 신규 사례, 57,000건 이상의 사망). 이러한 치료를 위한 유일한 임상적으로 검증된 테스트로서, 병리학자와 종양학자가 치료 선택에 도움을 줍니다.
Agilent Technologies (NYSE: A) a reçu la certification EU IVDR pour deux nouvelles indications de diagnostic compagnon pour son kit PD-L1 IHC 28-8 pharmDx, portant le total des indications européennes à neuf. Les approbations élargissent l'éligibilité au traitement pour :
1. Les patients atteints de cancer du poumon non à petites cellules (NSCLC) à un stade précoce avec une expression de PD-L1 ≥1% à haut risque de récidive, permettant un traitement avec OPDIVO® plus une chimiothérapie à base de platine.
2. Les patients atteints de mélanome avancé non traités auparavant (12+ ans) avec une expression de PD-L1 dans les cellules tumorales <1%, permettant un traitement avec Opdualag™.
Le kit, utilisé exclusivement avec l'Autostainer Link 48 d'Agilent, répond à des préoccupations de santé importantes : cancer du poumon (plus de 2 millions de nouveaux cas, 1,77 million de décès par an) et mélanome (plus de 324 000 nouveaux cas, plus de 57 000 décès par an). En tant que seul test cliniquement validé pour ces traitements, il aide les pathologistes et les oncologues dans le choix du traitement.
Agilent Technologies (NYSE: A) hat die EU IVDR-Zertifizierung für zwei neue begleitende diagnostische Indikationen für sein PD-L1 IHC 28-8 pharmDx-Kit erhalten, wodurch die Gesamtzahl der europäischen Indikationen auf neun erhöht wird. Die Genehmigungen erweitern die Behandlungsberechtigung für:
1. Patienten mit nicht-kleinzelligem Lungenkrebs (NSCLC) im Frühstadium mit PD-L1-Expression ≥1% und hohem Rückfallrisiko, was eine Behandlung mit OPDIVO® plus platinhaltiger Chemotherapie ermöglicht.
2. Zuvor unbehandelte Patienten mit fortgeschrittenem Melanom (12+ Jahre) mit PD-L1-Expression in Tumorzellen <1%, was eine Behandlung mit Opdualag™ ermöglicht.
Das Kit, das ausschließlich mit dem Autostainer Link 48 von Agilent verwendet wird, spricht bedeutende Gesundheitsprobleme an: Lungenkrebs (über 2 Millionen neue Fälle, 1,77 Millionen Todesfälle jährlich) und Melanom (über 324.000 neue Fälle, über 57.000 Todesfälle jährlich). Als der einzige klinisch validierte Test für diese Behandlungen unterstützt es Pathologen und Onkologen bei der Auswahl der Behandlung.
- Expansion to 9 total EU indications strengthens market position
- Exclusive platform compatibility ensures sustained equipment sales
- Large addressable market with 2+ million lung cancer and 324,000+ melanoma cases annually
- Only clinically validated test for these specific treatments, creating competitive advantage
- None.
Insights
Agilent's EU IVDR certification for its PD-L1 IHC 28-8 pharmDx kit represents a strategic expansion of its companion diagnostics portfolio in the European market. This approval is particularly noteworthy as it occurs under the new, more stringent EU IVDR regulatory framework, which replaced the previous IVD Directive with higher standards for clinical evidence, risk classification, and post-market surveillance.
The certification enables Agilent to extend testing to two substantial patient populations: early-stage NSCLC and previously untreated advanced melanoma patients. As the exclusive validated test for these specific Bristol Myers Squibb treatments, Agilent secures a protected position in the precision oncology testing workflow for these indications across Europe.
From a competitive standpoint, this further entrenches Agilent's leadership in immuno-oncology diagnostics. The company continues executing on its strategy of aligning with pharmaceutical partners to develop companion diagnostics that drive therapy selection. By expanding to nine total indications for this single test in Europe, Agilent creates economies of scale for labs already using their Autostainer Link 48 platform.
While the revenue impact is likely incremental rather than transformative for a company of Agilent's size (
The expansion of Agilent's PD-L1 test indications addresses critical therapeutic decision points in two deadly cancers. For NSCLC, identifying patients with ≥
For advanced melanoma, the companion diagnostic now identifies patients with
The clinical significance extends beyond just identifying more eligible patients. By precisely selecting appropriate patients for these immunotherapies, the test helps maximize therapeutic benefit while avoiding unnecessary treatment and toxicity in those unlikely to respond. This represents the essence of precision medicine.
From a healthcare systems perspective, having an IVDR-certified test brings standardization to biomarker testing across European healthcare systems, potentially reducing variability in patient selection and treatment outcomes. For pathologists and oncologists, having a single validated test that can inform multiple treatment decisions across different cancer types and stages streamlines the diagnostic workflow and may improve the consistency of PD-L1 assessment.
Lung cancer and malignant melanoma are major healthcare concerns worldwide, with lung cancer accounting for over two million new cases in 2020 and an estimated 1.77 million deaths each year, and malignant melanoma accounting for over 324,000 new cases in 2020 and over 57,000 deaths each year2. PD-L1 is a critical biomarker for potential response to anti-PD-1 therapies, which are revolutionizing the treatment of cancer. Pathology labs play an important role in informing treatment decisions.
When used in conjunction with the PD-L1 IHC 28-8 pharmDx as a companion test, in the European Union: (a) resectable NSCLC patients with PD-L1 expression ≥
PD-L1 IHC 28-8 pharmDx is the only clinically validated test for identifying patients for these treatments; these two new indications will aid pathologists, in conjunction with oncologists, in selecting appropriate treatment options, offering hope for patients diagnosed with these cancers. IVDR compliance certification further enhances the confidence of patients, consumers, and healthcare professionals in the EU by demonstrating that these medical devices can be safely relied upon as part of the diagnostic workflow.
Simon May, senior vice president of Agilent’s Life Sciences and Diagnostics Markets Group, remarked: “The two added indications of PD-L1 IHC 28-8 pharmDx will give physicians in
An innovative industry leader with more than 50 years of experience, Agilent launched the first FDA-approved companion diagnostic and continues to deliver world-class CDx products in close collaboration with pharma partners.
OPDIVO® is a registered trademark of Bristol-Myers Squibb Company; Opdualag™ is a trademark of Bristol-Myers Squibb Company.
- In Vitro Diagnostic Medical Devices Regulation (europa.eu)
- Sung. H., Ferlay. J., et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries, CA. Cancer J. Clin. 2021, 71, 209–249
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
View source version on businesswire.com: https://www.businesswire.com/news/home/20250310422488/en/
MEDIA CONTACT
Naomi Goumillout
Agilent Technologies Inc.
+1.781.266.2819
naomi.goumillout@agilent.com
Source: Agilent Technologies Inc.
FAQ
What are the two new EU IVDR approvals for Agilent's PD-L1 IHC 28-8 pharmDx test?
How many patients are affected by lung cancer and melanoma according to Agilent's release?
What specific treatments can be administered using Agilent's PD-L1 test results?
What is the significance of EU IVDR certification for Agilent's PD-L1 test?
