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Dako Announces CE Mark for Companion Diagnostic

Dako Announces CE Mark for Companion Diagnostic

Dako Announces CE Mark for Companion Diagnostic

Dako Announces CE Mark for Companion Diagnostic

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Dako has announced the CE Mark certification for use of a new companion diagnostic assay that can reveal whether a patient with advanced non-small cell lung cancer (NSCLC) is likely to respond to KEYTRUDA(r) (pembrolizumab), an anti-PD-1 therapy manufactured by Merck & Co., Inc., Kenilworth, N.J., USA. 

The CE marked PD-L1 IHC 22C3 pharmDx strengthens Agilent's portfolio of companion diagnostics and the company's leadership position in developing and commercializing companion diagnostic products.

PD-L1 IHC 22C3 pharmDx was developed in partnership with MSD. 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. Patients with EGFR or ALK positive tumor mutations should also have received approved therapy for these mutations prior to receiving KEYTRUDA.

KEYTRUDA is an immunotherapy that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby helping the immune system do what it is meant to do: help detect and fight cancer cells.

PD-L1 IHC 22C3 pharmDx was approved for use in the United States last year.

Lung cancer is the leading cause of cancer-related death worldwide, and NSCLC accounts for 80 percent of all lung cancers. PD-L1 IHC 22C3 pharmDx is the first and only companion diagnostic assay that has been validated and approved to identify NSCLC patients eligible for KEYTRUDA treatment.

"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," said Jacob Thaysen, president of Agilent's Diagnostics and Genomics Group. "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."

"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," said Dr. Roger Dansey, senior vice president, MSD Research Laboratories. "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."