Agilent Receives European IVDR Certification for Companion Diagnostic Assay in Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
Agilent Technologies (NYSE: A) has received European IVDR certification for its PD-L1 IHC 22C3 pharmDx assay as a Companion Diagnostic (CDx) for gastric or gastroesophageal junction (GEJ) adenocarcinoma patients. The certification aids in identifying patients eligible for KEYTRUDA® therapy.
The assay is now IVDR certified for seven cancer indications, including non-small cell lung cancer, urothelial carcinoma, esophageal cancer, head and neck squamous cell carcinoma, triple-negative breast cancer, and cervical cancer. It remains the only IVDR-certified CDx for gastric and GEJ adenocarcinoma patients seeking KEYTRUDA treatment.
This expansion is particularly significant given that gastric cancer affected over 130,000 Europeans in 2022, with a 5-year survival rate of 26% in Europe. The assay works exclusively with Agilent's Autostainer Link 48 advanced staining solution.
Agilent Technologies (NYSE: A) ha ottenuto la certificazione europea IVDR per il suo test PD-L1 IHC 22C3 pharmDx come diagnostico complementare (CDx) per pazienti con adenocarcinoma gastrico o della giunzione gastroesofagea (GEJ). Questa certificazione supporta l'identificazione dei pazienti idonei alla terapia con KEYTRUDA®.
Il test è ora certificato IVDR per sette indicazioni oncologiche, tra cui carcinoma polmonare non a piccole cellule, carcinoma uroteliale, cancro esofageo, carcinoma squamoso della testa e del collo, carcinoma mammario triplo negativo e cancro cervicale. Rimane l'unico CDx certificato IVDR per pazienti con adenocarcinoma gastrico e GEJ candidati al trattamento con KEYTRUDA.
Questa espansione è particolarmente rilevante considerando che nel 2022 il cancro gastrico ha colpito oltre 130.000 europei, con un tasso di sopravvivenza a 5 anni del 26% in Europa. Il test funziona esclusivamente con la soluzione avanzata di colorazione Autostainer Link 48 di Agilent.
Agilent Technologies (NYSE: A) ha recibido la certificación europea IVDR para su ensayo PD-L1 IHC 22C3 pharmDx como diagnóstico complementario (CDx) para pacientes con adenocarcinoma gástrico o de la unión gastroesofágica (GEJ). La certificación ayuda a identificar a los pacientes elegibles para la terapia con KEYTRUDA®.
El ensayo ahora está certificado bajo IVDR para siete indicaciones oncológicas, incluyendo cáncer de pulmón no microcítico, carcinoma urotelial, cáncer de esófago, carcinoma de células escamosas de cabeza y cuello, cáncer de mama triple negativo y cáncer cervical. Sigue siendo el único CDx certificado por IVDR para pacientes con adenocarcinoma gástrico y GEJ que buscan tratamiento con KEYTRUDA.
Esta ampliación es especialmente significativa dado que en 2022 el cáncer gástrico afectó a más de 130,000 europeos, con una tasa de supervivencia a 5 años del 26% en Europa. El ensayo funciona exclusivamente con la solución avanzada de tinción Autostainer Link 48 de Agilent.
Agilent Technologies (NYSE: A)는 위암 또는 위식도 접합부(GEJ) 선암 환자를 위한 동반 진단(CDx)으로서 PD-L1 IHC 22C3 pharmDx 검사에 대해 유럽 IVDR 인증을 받았습니다. 이 인증은 KEYTRUDA® 치료 대상 환자를 식별하는 데 도움을 줍니다.
이 검사는 비소세포폐암, 요로상피세포암, 식도암, 두경부 편평세포암, 삼중음성 유방암, 자궁경부암 등 7가지 암 적응증에 대해 IVDR 인증을 받았습니다. 위암 및 GEJ 선암 환자 중 KEYTRUDA 치료를 받는 유일한 IVDR 인증 CDx로 남아 있습니다.
이 확장은 2022년에 유럽에서 13만 명 이상의 위암 환자가 발생했으며, 5년 생존율이 26%인 점을 고려할 때 특히 중요합니다. 이 검사는 Agilent의 Autostainer Link 48 고급 염색 솔루션과 독점적으로 작동합니다.
Agilent Technologies (NYSE: A) a obtenu la certification européenne IVDR pour son test PD-L1 IHC 22C3 pharmDx en tant que diagnostic compagnon (CDx) pour les patients atteints d’adénocarcinome gastrique ou de la jonction gastro-œsophagienne (GEJ). Cette certification facilite l’identification des patients éligibles à la thérapie par KEYTRUDA®.
Le test est désormais certifié IVDR pour sept indications cancéreuses, dont le cancer du poumon non à petites cellules, le carcinome urothélial, le cancer de l’œsophage, le carcinome épidermoïde de la tête et du cou, le cancer du sein triple négatif et le cancer du col de l’utérus. Il reste le seul CDx certifié IVDR pour les patients atteints d’adénocarcinome gastrique et GEJ candidats au traitement par KEYTRUDA.
Cette extension est particulièrement importante étant donné que le cancer gastrique a touché plus de 130 000 Européens en 2022, avec un taux de survie à 5 ans de 26 % en Europe. Le test fonctionne exclusivement avec la solution de coloration avancée Autostainer Link 48 d’Agilent.
Agilent Technologies (NYSE: A) hat die europäische IVDR-Zertifizierung für seinen PD-L1 IHC 22C3 pharmDx-Test als Begleitdiagnostikum (CDx) für Patienten mit Magen- oder gastroösophagealem Übergang (GEJ) Adenokarzinom erhalten. Die Zertifizierung unterstützt die Identifizierung von Patienten, die für eine KEYTRUDA®-Therapie geeignet sind.
Der Test ist nun IVDR-zertifiziert für sieben Krebsindikationen, darunter nicht-kleinzelliges Lungenkarzinom, Urothelkarzinom, Speiseröhrenkrebs, Plattenepithelkarzinom des Kopf- und Halsbereichs, dreifach-negativen Brustkrebs und Gebärmutterhalskrebs. Er bleibt der einzige IVDR-zertifizierte CDx für Patienten mit Magen- und GEJ-Adenokarzinom, die eine KEYTRUDA-Behandlung anstreben.
Diese Erweiterung ist besonders bedeutsam, da im Jahr 2022 über 130.000 Europäer an Magenkrebs erkrankten, mit einer 5-Jahres-Überlebensrate von 26 % in Europa. Der Test funktioniert ausschließlich mit der fortschrittlichen Färbelösung Autostainer Link 48 von Agilent.
- Expanded market opportunity with new European IVDR certification
- Only IVDR-certified CDx for gastric and GEJ adenocarcinoma KEYTRUDA treatment
- Certification covers seven different cancer indications
- Large addressable market with 130,000+ European gastric cancer patients annually
- None.
Insights
Agilent's PD-L1 diagnostic assay gains European certification for gastric cancer patients, expanding its precision medicine footprint and strengthening partnership with Merck.
Agilent's European IVDR certification for its PD-L1 IHC 22C3 pharmDx assay represents a significant expansion in precision oncology diagnostics. This companion diagnostic now spans seven cancer indications, making it the only IVDR-certified test to identify gastric/GEJ adenocarcinoma patients eligible for KEYTRUDA therapy.
The clinical significance is substantial. With over 130,000 Europeans diagnosed with gastric cancer in 2022 and a dismal 26% five-year survival rate, accurate patient selection for immunotherapy is critical. This assay enables identification of patients whose tumors express PD-L1 (CPS ≥1), a biomarker that predicts response to KEYTRUDA in combination with other therapies.
From a technological perspective, this approval leverages Agilent's existing Autostainer Link 48 platform, creating a razor/razor-blade business model where the instrument drives ongoing assay sales. The standardized testing approach ensures consistent results across laboratories, critical for therapeutic decision-making.
This certification reinforces Agilent's expanding footprint in the companion diagnostics market, where tests are directly linked to specific therapeutics. As KEYTRUDA's approved indications grow, Agilent's diagnostic follows, creating additional revenue streams with minimal additional development costs.
This European IVDR certification represents a strategic market expansion for Agilent in the high-margin companion diagnostics sector. By securing the exclusive certification for gastric/GEJ adenocarcinoma patient identification for KEYTRUDA therapy, Agilent has established a competitive moat in this specific indication.
The European gastric cancer market presents significant commercial opportunity with 130,000+ annual diagnoses. This certification creates a mutually reinforcing partnership with Merck – as KEYTRUDA adoption increases in these indications, demand for Agilent's diagnostic assay grows proportionally.
What's particularly valuable from a business perspective is how Agilent has leveraged its existing technology platform to access new revenue streams. This represents an efficient capital allocation strategy where a single diagnostic technology (PD-L1 IHC 22C3 pharmDx) is systematically expanded across multiple cancer indications, each representing a separate revenue opportunity.
This approval also strengthens Agilent's broader oncology diagnostics portfolio, complementing their existing certifications in six other cancer types. The assay's compatibility exclusively with Agilent's Autostainer Link 48 creates an ecosystem that drives both instrument placements and recurring assay revenue – a classic razor/razor-blade model that typically delivers superior margins and customer retention.
European certification for PD-L1 IHC 22C3 pharmDx to help gastric or GEJ adenocarcinoma patients for KEYTRUDA® therapy
In addition to gastric or GEJ adenocarcinoma, PD-L1 IHC 22C3 pharmDx is IVDR certified as an aid in identifying non-small cell lung cancer (NSCLC), urothelial carcinoma, esophageal cancer, head and neck squamous cell carcinoma (HNSCC), triple-negative breast cancer (TNBC), and cervical cancer patients for treatment with KEYTRUDA. Consequently, PD-L1 IHC 22C3 pharmDx is labeled for seven cancer indications and is the only IVDR-certified CDx to identify gastric and GEJ adenocarcinoma patients for treatment with KEYTRUDA.
“Immunotherapies, such as KEYTRUDA, are critical for cancer patients,” said Nina Green, vice president and general manager of the Clinical Diagnostics Division at Agilent. “With the current European indication expansion of PD-L1 IHC 22C3 pharmDx into gastric or GEJ adenocarcinoma, pathology laboratories can now support an even broader patient population in determining their eligibility for relevant treatment options.”
Gastric cancer is a leading cause of cancer-related mortality worldwide. In
In
PD-L1 IHC 22C3 pharmDx was developed by Agilent in partnership with Merck (known as MSD outside
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.,
References: |
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| 1. |
PD-L1 IHC 22C3 pharmDx. |
| 2. | Rawal, P.; Barsouk, A. Epidemiology of gastric cancer: global trends, risk factors and prevention. Prz Gastroenterol. 2019, 14 (1), 26–38. |
| 3. |
International Agency for Research on Cancer, World Health Organization. Global Cancer Observatory, Factsheet, |
| 4. | Keytruda. European Medicines Agency. https://www.ema.europa.eu/en/medicines/human/EPAR/keytruda |
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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FAQ
What is the significance of Agilent's (NYSE: A) new European IVDR certification for PD-L1 IHC 22C3 pharmDx?
How many cancer indications is Agilent's PD-L1 IHC 22C3 pharmDx now certified for in Europe?
What is the current gastric cancer situation in Europe according to Agilent's announcement?
How is Agilent's PD-L1 IHC 22C3 pharmDx used in combination with KEYTRUDA for gastric cancer treatment?
