Agilent Technologies today announced the issuance of a Class C Companion Diagnostic (CDx) In Vitro Diagnostic Regulation (IVDR) certification for its PD-L1 IHC 28-8 pharmDx (Code SK005) assay. This diagnostic tool, which had previously received CE-IVD marking for sales within the European Union, is now officially certified in compliance with the updated EU Regulation for in vitro diagnostic medical devices (IVDR). The certification strengthens the assay’s role in precision medicine by ensuring that it meets the rigorous safety and performance standards required by European regulatory authorities.
PD-L1 IHC 28-8 pharmDx (Code SK005) is designed to work exclusively with the Agilent Autostainer Link 48, an advanced staining system that enhances the assay’s reliability and performance. This companion diagnostic assay provides essential clinical data on the expression of PD-L1, a critical biomarker that plays a pivotal role in assessing the potential efficacy of therapies that include anti-PD-1 antibodies. These therapies, such as OPDIVO® (nivolumab) and OpdualagTM (nivolumab and relatimab), have shown therapeutic promise in a growing range of cancer indications, making accurate biomarker testing crucial for optimal patient outcomes.
The PD-L1 IHC 28-8 pharmDx assay has received IVDR certification for use in nine cancer indications, five of which are companion diagnostic indications. These include non-small cell lung cancer (NSCLC), muscle-invasive urothelial carcinoma (MIUC), melanoma, esophageal squamous cell carcinoma (ESCC), and gastric, gastroesophageal junction (GEJ), and esophageal adenocarcinoma. This broad approval underscores the assay’s critical role in guiding personalized treatment decisions for patients suffering from various types of cancer.
Simon May, Senior Vice President of Agilent’s Life Sciences and Diagnostics Markets Group, emphasized the importance of this achievement, stating, “The IVDR certification of PD-L1 IHC 28-8 pharmDx as a Class C-CDx device is a significant milestone. It enhances the confidence of healthcare professionals and patients across the EU, demonstrating that these medical devices can be relied upon safely to provide critical diagnostic information.”
Companion diagnostic assays, such as PD-L1 IHC 28-8 pharmDx, are crucial tools in modern healthcare. They help identify patients who are most likely to benefit from specific drug treatments, ensuring that therapies are directed to those who will benefit the most. This personalized approach to treatment is becoming increasingly important in oncology, where the effectiveness of many cancer therapies depends on the presence of specific biomarkers like PD-L1.
The certification of PD-L1 IHC 28-8 pharmDx under the IVDR regulation also has significant implications for laboratories across the European Union. These labs, which rely on Agilent products in their diagnostic workflows, can now continue using the PD-L1 IHC 28-8 pharmDx without disruption. The IVDR-compliant certification ensures that Agilent’s diagnostic assays adhere to the latest standards for safety, performance, and reliability, providing laboratories and clinicians with the confidence they need to make informed decisions.
This development marks another important step in Agilent’s ongoing commitment to advancing precision medicine. The company’s portfolio of diagnostic assays plays a key role in supporting personalized treatment strategies, particularly in oncology, where biomarkers like PD-L1 are increasingly used to guide therapy decisions. By providing healthcare professionals with reliable tools to assess PD-L1 expression, Agilent is helping to improve patient outcomes by ensuring that the most effective therapies are used for the right patients.
Agilent Technologies continues to lead in the field of diagnostics, working to develop and deliver solutions that meet the evolving needs of healthcare professionals and patients. The IVDR certification of PD-L1 IHC 28-8 pharmDx is just one example of the company’s dedication to advancing healthcare through innovation and collaboration with the global medical community. With this certification, Agilent’s companion diagnostic assays will continue to play an essential role in providing healthcare professionals with the information they need to make the best possible treatment decisions for their patients.
As the healthcare industry increasingly moves toward personalized treatments based on biomarkers, Agilent’s commitment to providing high-quality, IVDR-compliant diagnostic assays reinforces its role as a trusted partner in healthcare, helping to shape the future of cancer treatment and beyond.
