The company received E Mark certification for use of a new companion diagnostic assay, which will help to reveal whether or not a patient with advanced non-small cell lung cancer (NSCLC) is likely to respond to Merck's anti-PD-1 therapy KEYTRUDA (pembrolizumab).

The CE marked PD-L1 IHC 22C3 pharmDx expands Agilent's portfolio of companion diagnostics.

KEYTRUDA has been approved to treat patients with locally advanced or metastatic NSCLC whose tumors express PD-L1, as determined by the companion diagnostic assay, and who have received at least one prior chemotherapy regimen.

KEYTRUDA is an immunotherapy acts as a blockage between PD-1 and its ligands, PD-L1 and PD-L2 and helps the immune system in detecting and fighting cancer cells. PD-L1 IHC 22C3 pharmDx received approval in US last year.

Lung cancer is one of the leading causes of cancer-related deaths worldwide and 80% of lung cancer cases are NSCLC. Agilent claims that PD-L1 IHC 22C3 pharmDx is the first and only companion diagnostic assay to have been validated to identify NSCLC patients eligible for KEYTRUDA treatment.

Agilent Diagnostics and Genomics Group president Jacob Thaysen said: “Because individuals often respond differently to the same treatment, scientists have been putting more emphasis on personalized medicine, which is where PD-L1 IHC 22C3 pharmDx comes into play.

“This is a new era in immuno-oncology, and we are particularly excited about Agilent’s involvement in advancements in cancer treatment and the potential PD-L1 IHC 22C3 pharmDx has in helping to identify patients with non-small cell lung cancer who are likely to benefit from treatment with KEYTRUDA.”

MSD Research Laboratories senior vice president Roger Dansey said: “We believe that testing for the PD-L1 biomarker can provide important information that will help guide treatment decisions for patients with metastatic non-small cell lung cancer.

“We are looking forward to working with Dako to make PD-L1 testing a routine part of the diagnosis and treatment for patients with non-small cell lung cancer living in Europe.”