SHERIDAN, WYOMING – May 8, 2025 – Agilent Technologies Inc. (NYSE: A) has announced that its PD-L1 IHC 22C3 pharmDx (Code SK006) assay has achieved European IVDR certification. This certification positions the assay as a Companion Diagnostic (CDx) to identify gastric or gastroesophageal junction (GEJ) adenocarcinoma patients eligible for treatment with KEYTRUDA® (pembrolizumab), a leading anti-PD-1 therapy developed by Merck. The certification expands the test’s application, offering a significant advancement in cancer treatment options for a growing patient demographic.
Expanded Indication for Critical Cancer Treatment
The PD-L1 IHC 22C3 pharmDx assay, which is approved for exclusive use with the Agilent Autostainer Link 48 advanced staining solution, is now officially IVDR certified to help identify patients with gastric or GEJ adenocarcinoma who may be candidates for KEYTRUDA therapy. In addition to this new certification for gastric cancer, the assay is also recognized for use in 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. This makes the PD-L1 IHC 22C3 pharmDx assay 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.”
Market Impact and Industry Relevance
Gastric cancer remains a leading cause of cancer-related deaths globally, with significant challenges in treatment and diagnosis. In Europe, gastric adenocarcinoma is often diagnosed at an advanced stage, resulting in a five-year survival rate of just 26%. More than 130,000 Europeans were diagnosed with gastric cancer in 2022 alone. The new certification of PD-L1 IHC 22C3 pharmDx for gastric and GEJ adenocarcinoma patients enhances the ability to offer more precise and effective treatments through KEYTRUDA, potentially improving outcomes for thousands of patients across Europe.
In Europe, KEYTRUDA is now indicated for use in combination with trastuzumab, fluoropyrimidine, and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced, unresectable, or metastatic HER2-positive gastric or GEJ adenocarcinoma whose tumors express PD-L1 (CPS ≥ 1). Additionally, the therapy is indicated for HER2-negative gastric or GEJ adenocarcinoma patients with PD-L1 expression (CPS ≥ 1), offering a broader treatment avenue for those diagnosed with this challenging disease.
A Partnership That Advances Cancer Care
The PD-L1 IHC 22C3 pharmDx assay was developed by Agilent in collaboration with Merck, known as MSD outside the United States and Canada. The collaboration has provided a powerful tool for clinicians to identify patients who may benefit from KEYTRUDA therapy, making it an essential part of personalized cancer treatment strategies.
“Working with Agilent to bring this important diagnostic tool to market allows for better patient outcomes by ensuring the right therapies are administered to the right patients,” said a spokesperson from Merck. “The expanded European certification of PD-L1 IHC 22C3 pharmDx further solidifies the role of precision medicine in the treatment of multiple cancers.”
Conclusion and Future Outlook
Agilent’s receipt of the European IVDR certification for its PD-L1 IHC 22C3 pharmDx assay marks a pivotal step in enhancing the accessibility of KEYTRUDA for gastric and GEJ adenocarcinoma patients. As the demand for immunotherapies grows, this innovation plays a critical role in improving diagnosis, streamlining treatment planning, and ultimately increasing patient survival rates. To learn more about Agilent Technologies and their advancements in cancer diagnostics, visit www.agilent.com.