Agilent Technologies Inc. has announced expanded access to a clinically validated test for PD-L1 (programmed death-ligand 1), that will help physicians in Europe make more informed decisions about how best to treat patients with Urothelial Cancer (UC).
Europe is the first region to launch a PD-L1 CE-IVD test for UC globally. The CE marking demonstrates the product meets all relevant European Medical Device Directives. The PD-L1 IHC 28-8 pharmDx has broad utility as it has already been previously CE marked for detecting tumor cell PD-L1 expression for non-squamous, non-small-cell lung cancer, squamous cell carcinoma of head and neck and melanoma. PD-L1 IHC 28-8 pharmDx now has more clinically validated tissue indications than any other commercially manufactured PD-L1 assay on the market.
Opdivo (nivolumab), an immunotherapy developed by Bristol-Myers Squibb, is indicated for the treatment of previously treated locally advanced unresectable or metastatic UC in adults after failure of prior platinum-containing therapy regardless of PD-L1 status. Data from a recent clinical study CA209275 (Checkmate 275), showed that tumor PD-L1 expression assessed by PD-L1 IHC 28-8 pharmDx may help inform which UC patients are more likely to respond to Opdivo.
Because individual patients may respond differently to the same treatment, scientists have been focusing on the development of personalized medicine, which is where Agilent's Dako brand of diagnostics comes into play, providing important information about the status of key biomarkers in individual cancer patients.
Agilent is a worldwide leader in partnering with pharmaceutical companies to develop immunohistochemical-based diagnostics for cancer therapy.
Expanded use in other countries is currently pending approval. - Business Wire