Agilent diagnostic test approved for urothelial cancer in Europe

Agilent Technologies has announced that one of its cancer diagnostic tests is to be made available for use in the treatment of urothelial cancer in Europe.

The PD-L1 IHC 28-8 pharmDx test has received CE Mark approval as a means to determining which patients would be most likely to benefit from treatment with the cancer therapy Opdivo.

Developed by Bristol-Myers Squibb, Opdivo is an immunotherapy that responds differently in patients depending on the PD-L1 expression levels in their tumour cells. Data from a recent clinical study showed that the PD-L1 IHC 28-8 pharmDx test can help inform which urothelial cancer patients are more likely to respond well to Opdivo.

Agilent said: "Because individual patients may respond differently to the same treatment, scientists have been focusing development of personalised medicine, which is where Agilent's Dako brand of diagnostics comes into play, providing important information about the status of key biomarkers in individual cancer patients."

This makes Europe the first region in the world to launch a PD-L1 CE-IVD test for this form of cancer. The PD-L1 IHC 28-8 pharmDx test already has previous CE Mark approval for detecting PD-L1 expression for non-squamous, non-small-cell lung cancer, squamous cell carcinoma of the head and neck, and melanoma.

As such, the test offers more clinically-validated tissue indications than any other commercially manufactured PD-L1 assay on the market.

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