Dako, Agilent Pathology Solutions, a worldwide leader in partnering with pharmaceutical companies to develop immunohistochemical-based diagnostics for cancer therapy, today 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® (pembrolizumab), an anti-PD-1 therapy manufactured by Merck & Co., Inc., Kenilworth, N.J., USA (known as MSD outside the U.S. and Canada).
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