Dako Announces Expanded Use of PD-L1 Diagnostic Test in Europe

Dako, Agilent Pathology Solutions, a worldwide leader in partnering with pharmaceutical companies to develop immunohistochemical based diagnostics for cancer therapy, recently 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 standardised 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).”

In 2012, Agilent acquired Dako, a well-known provider of reagents, instruments, software and expertise. Agilent’s Dako pathology solutions help pathologists make accurate diagnoses and determine the most effective treatment for cancer patients.

Information about Agilent is available online and information about Agilent’s Dako pathology solutions is available here.