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Dako announces expanded use of PD-L1 diagnostic test in Europe

MDBR Staff Writer Published 13 May 2016

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

Agilent Technologies Inc. (NYSE: A), a global leader in life sciences, diagnostics and applied chemical markets, is the premier laboratory partner for a better world. Agilent works with customers in more than 100 countries, providing instruments, software, services and consumables for the entire laboratory workflow.

The company generated revenues of $4.04 billion in fiscal 2015 and employs about 12,000 people worldwide.
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.



Source: Company Press Release