Agilent Technologies Inc. (NYSE: A) has announced that its PD-L1 IHC 28-8 pharmDx diagnostic kit has received certification for two new companion diagnostic indications under the European Union's In Vitro Diagnostic Medical Devices Regulation (EU IVDR). This expansion broadens treatment eligibility for patients with early-stage non-small cell lung cancer (NSCLC) and previously untreated advanced melanoma.
The newly approved indications bring the total number of indications for PD-L1 IHC 28-8 pharmDx in Europe to nine. The diagnostic kit is exclusively approved for use with Agilent's Autostainer Link 48 advanced staining solution.
Clinical Significance and Disease Burden
Lung cancer and malignant melanoma represent significant global health challenges. Lung cancer accounted for over two million new cases in 2020 and approximately 1.77 million deaths annually. Malignant melanoma contributed to more than 324,000 new cases and over 57,000 deaths in the same year.
PD-L1 (Programmed Death-Ligand 1) serves as a critical biomarker for predicting potential response to anti-PD-1 therapies, which have revolutionized cancer treatment approaches. Pathology laboratories play an essential role in generating the diagnostic information that informs these treatment decisions.
Expanded Treatment Options
When used as a companion diagnostic test in the European Union, the PD-L1 IHC 28-8 pharmDx kit enables:
- Resectable NSCLC patients with PD-L1 expression ≥1% and at high risk of recurrence to potentially qualify for treatment with Bristol Myers Squibb's OPDIVO® (nivolumab) in combination with platinum-based chemotherapy
- Patients 12 years and older with tumor cell PD-L1 expression <1% who have previously untreated advanced (metastatic or unresectable) melanoma to potentially qualify for treatment with Bristol Myers Squibb's Opdualag™ (nivolumab and relatlimab)
Clinical Validation and Regulatory Significance
The PD-L1 IHC 28-8 pharmDx is currently the only clinically validated test for identifying patients eligible for these specific treatments. The IVDR compliance certification enhances confidence among patients, consumers, and healthcare professionals in the European Union by demonstrating that these diagnostic devices meet rigorous safety and performance standards.
Simon May, Senior Vice President of Agilent's Life Sciences and Diagnostics Markets Group, emphasized the importance of this development: "The two added indications of PD-L1 IHC 28-8 pharmDx will give physicians in Europe critical information to inform treatment decisions for patients with these common and potentially deadly cancers. This endorsement underscores Agilent's leadership in the development of companion diagnostics for groundbreaking therapies containing anti-PD-1 antibodies."
Agilent's Leadership in Companion Diagnostics
With more than 50 years of industry experience, Agilent has established itself as a pioneer in companion diagnostics development. The company launched the first FDA-approved companion diagnostic and continues to deliver high-quality CDx products through close collaborations with pharmaceutical partners.
The expanded indications for the PD-L1 IHC 28-8 pharmDx kit represent a significant advancement in precision medicine for European cancer patients, potentially improving treatment outcomes for those diagnosed with NSCLC and advanced melanoma.
