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Agilent Opdivo CDx Approved for Expanded Use in Europe

NEW YORK (GenomeWeb) – Agilent Technologies announced today that it has been granted expanded use in Europe for its Dako PD-L1 IHC 28-8 pharmDx test, a companion diagnostic for Bristol-Myers Squibb's cancer drug Opdivo (nivolumab).

According to Agilent, the test is now approved for identifying patients with squamous cell carcinoma of the head and neck who are likely to benefit from Opdivo therapy. The test is already approved in Europe for tumor cell PD-L1 expression for non-squamous non-small-cell lung cancer (ns-NSCLC) and melanoma.

It is also approved in the US as a complementary diagnostic for Opdivo for ns-NSCLC and for assessing the magnitude of benefit melanoma patients might derive from the drug. 

"We recently saw the first approval for the PD-L1 IHC 28-8 pharmDx test in head and neck cancer in Japan, and are now pleased that the CE marked indication has been extended to Europe," Jacob Thaysen, president of Agilent's diagnostics and genomics group, said in a statement. "Head and neck cancer has few treatment options, and tumor PD-L1 testing can identify patients with this devastating disease who are most likely to benefit from Opdivo therapy."

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