Dako, Agilent Pathology Solutions, a worldwide leader in partnering with pharmaceutical companies to develop immunohistochemical-based diagnostics for cancer therapy, today announced an expansion of the intended use of the PD-L1 IHC 28-8 pharmDx test in Europe to include patients with melanoma cancer.
Previously approved in the U.S. for non-squamous non-small-cell lung cancer (ns-NSCLC) and melanoma and later launched in Europe for ns-NSCLC, the PD-L1 IHC 28-8 pharmDx test has now been expanded to include melanoma in Europe. This allows physicians to determine PD-L1 expression for melanoma patients using a clinically validated test. The PD-L1 IHC 28-8 PharmDx test was used to assess PD-L1 expression in the CheckMate -067 trial and is now approved to be used as an aid in the assessment of patients for whom OPDIVO® (nivolumab) and YERVOY® (ipilimumab) combination treatment is being considered.
"This important launch enables standardized testing for PD-L1 expression," said Jacob Thaysen, president of Agilent's Diagnostics and Genomics Group. "Pathology laboratories in the EU now have access to CE-marked clinically-validated PD-L1 tests for ns-NSCLC correlated with outcomes from treatment with OPDIVO, and melanoma correlated with outcomes from combination treatment with OPDIVO® (nivolumab) and YERVOY® (ipilimumab)."