Agilent Earns IVDR Certification for Gastric Cancer Companion Diagnostic
Agilent Technologies Inc. (NYSE: A) announced that its PD-L1 IHC 22C3 pharmDx assay (Code SK006) has received European In Vitro Diagnostic Regulation (IVDR) certification for use as a Companion Diagnostic (CDx) to help identify patients with gastric or gastroesophageal junction (GEJ) adenocarcinoma who may be eligible for treatment with KEYTRUDA® (pembrolizumab). This assay is validated for use exclusively with the Agilent Autostainer Link 48, an advanced platform for automated tissue staining.
KEYTRUDA, a widely used anti-PD-1 immunotherapy, is developed by Merck (known as MSD outside the United States and Canada). With this new certification, Agilent’s PD-L1 IHC 22C3 pharmDx becomes the first and only IVDR-certified CDx for identifying gastric and GEJ adenocarcinoma patients eligible for treatment with KEYTRUDA in Europe.
This expansion significantly strengthens the assay’s role in oncology diagnostics. In addition to gastric and GEJ cancers, PD-L1 IHC 22C3 pharmDx is already IVDR-certified to support treatment decisions for six other cancers: 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. With seven indications now covered, the assay continues to broaden its clinical utility in precision medicine.
“Immunotherapies like KEYTRUDA have transformed cancer care and offer new hope to patients,” said Nina Green, Vice President and General Manager of Agilent’s Clinical Diagnostics Division. “This expanded indication under IVDR allows pathology labs across Europe to support a wider range of cancer patients in accessing appropriate therapies based on biomarker testing.”
Gastric cancer remains one of the leading causes of cancer-related deaths globally. In Europe alone, over 130,000 people were diagnosed with gastric cancer in 2022. The majority of cases are diagnosed at advanced stages, contributing to a low five-year survival rate of just 26%. This highlights the urgent need for effective treatment strategies and timely diagnostics.
Under the current European Medicines Agency (EMA) guidelines, KEYTRUDA is approved in combination with chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. Treatment options differ based on HER2 expression and PD-L1 status. Specifically:
- For HER2-positive tumors with a PD-L1 Combined Positive Score (CPS) ≥1, KEYTRUDA is used alongside trastuzumab and a fluoropyrimidine and platinum-based chemotherapy.
- For HER2-negative tumors with PD-L1 CPS ≥1, KEYTRUDA is combined with fluoropyrimidine and platinum-based chemotherapy.
Accurately identifying patients who meet these biomarker criteria is essential for optimizing treatment outcomes. The PD-L1 IHC 22C3 pharmDx assay plays a crucial role in this process by detecting PD-L1 expression levels in tumor tissue, enabling physicians to make informed decisions about immunotherapy eligibility.
Agilent developed the PD-L1 IHC 22C3 pharmDx assay in collaboration with Merck as part of a broader effort to support personalized cancer treatment. Their partnership aims to deliver clinically validated and regulatory-compliant diagnostic tools that can guide the use of targeted therapies like KEYTRUDA.
IVDR certification represents a significant regulatory milestone. It ensures that diagnostic products meet the European Union’s updated standards for safety, performance, and scientific validity. As a result, clinicians and laboratories can rely on Agilent’s assay not only for its technical accuracy but also for its compliance with the most rigorous diagnostic regulations in Europe.
Agilent’s continued expansion of the PD-L1 IHC 22C3 pharmDx assay into additional cancer indications aligns with its mission to provide innovative, trusted solutions that enhance patient care. By supporting broader use across multiple cancer types and diagnostic environments, Agilent is helping clinicians deliver personalized treatments that improve outcomes and quality of life for patients worldwide.
About Agilent Technologies
Agilent Technologies Inc. (NYSE: A) is a global leader in life sciences, diagnostics, and applied chemical markets. The company offers a comprehensive portfolio of instruments, software, services, and expertise that help scientists and healthcare professionals solve complex analytical challenges. Agilent generated $6.51 billion in revenue in fiscal year 2024 and employs approximately 18,000 people globally.
