Agilent test approved for new cancer diagnostic indication

Agilent Technologies has announced that its Dako PD-L1 IHC 28-8 pharmDx test has been approved in Europe in a new indication.

The test has been ratified for use in the detection of squamous cell carcinoma of the head and neck, the most prevalent type of head and neck cancer. This makes Europe the first region to launch a PD-L1 CE-IVD test for this disease.

Using this test, it is possible to screen patients for their PD-L1 status, information that is vital to identify which patients could most likely benefit from treatment with Opdivo, an immunotherapy developed by Bristol-Myers Squibb.

Data from a study showed that tumour PD-L1 expression, as detected by the PD-L1 IHC 28-8 pharmDx test, may be associated with an enhanced survival benefit from the use of Opdivo.

Jacob Thaysen, president of Agilent's diagnostics and genomics group, said: "Head and neck cancer has few treatment options, and tumour PD-L1 testing can identify patients with this devastating disease who are most likely to benefit from Opdivo therapy."

The test has previously received CE Mark approval to aid the treatment of non-squamous, non-small-cell lung cancer and melanoma.

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