Agilent Technologies Secures European IVDR Certification for Pivotal Companion Diagnostic Assay
Agilent Technologies Inc. (NYSE: A) has made a significant advancement in cancer diagnostics with the announcement of its PD-L1 IHC 22C3 pharmDx (Code SK006) assay receiving European In Vitro Diagnostic Regulation (IVDR) certification. This certification enables the assay to be used 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), an anti-PD-1 therapy developed by Merck.
1. A New Era for Gastric Cancer Diagnostics
The PD-L1 IHC 22C3 pharmDx assay is not only pivotal for gastric and GEJ adenocarcinoma but is also certified to assist in identifying several other cancer types. This includes 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 this latest certification, the assay is now labeled for seven cancer indications, making it the only IVDR-certified CDx specifically for gastric and GEJ adenocarcinoma patients.
Nina Green, Vice President and General Manager of the Clinical Diagnostics Division at Agilent, expressed the importance of this development, stating, “Immunotherapies, such as KEYTRUDA, are critical for cancer patients. 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.”
2. The Urgency of Gastric Cancer Diagnosis
Gastric cancer remains a leading cause of cancer-related mortality around the globe, with the disease often diagnosed at an advanced stage. In Europe, gastric adenocarcinoma has a disheartening 5-year survival rate of just 26%, highlighting the urgent need for effective diagnostic tools and treatments. In 2022, over 130,000 Europeans were diagnosed with gastric cancer, underscoring the pressing requirement for innovative solutions in this area.
In conjunction with KEYTRUDA, the PD-L1 IHC 22C3 pharmDx assay will play a crucial role in optimizing treatment strategies for patients suffering from this challenging disease. The combination of KEYTRUDA with trastuzumab, fluoropyrimidine, and platinum-containing chemotherapy is indicated for first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or GEJ adenocarcinoma whose tumors express PD-L1 (CPS ≥ 1). Similarly, for HER2-negative gastric or GEJ adenocarcinoma patients, the combination with fluoropyrimidine and platinum-containing chemotherapy is also indicated for first-line treatment with the same PD-L1 expression criteria.
3. Collaborative Development and Future Implications
The PD-L1 IHC 22C3 pharmDx assay was developed in partnership with Merck, which reinforces the collaborative efforts in advancing cancer diagnostics and therapies. This partnership aims to enhance patient outcomes by ensuring that individuals receive the most appropriate treatments based on their specific cancer profiles.
As Agilent continues to expand its diagnostic offerings, the European IVDR certification marks a pivotal milestone that promises to enhance the precision of cancer treatment and improve patient outcomes across Europe.
4. About Agilent Technologies
Agilent Technologies Inc. is a global leader in analytical and clinical laboratory technologies, dedicated to delivering insights and innovation that empower scientific advancement. With a revenue of $6.51 billion in fiscal year 2024 and a workforce of approximately 18,000 employees worldwide, Agilent plays a vital role in providing trusted answers to complex scientific questions. For further information on Agilent and its latest advancements, visit their official website.
