Agilent’s PD-L1 diagnostic test approved for expanded European indication

Agilent Technologies has announced that one of its PD-L1 diagnostic tests has been approved for an expanded indication in Europe.

The company has received CE Mark approval for the expansion of the intended use of its PD-L1 IHC 28-8 pharmDx test in Europe to include patients with melanoma. The test was developed by its subsidiary Dako.

This test was originally approved in the US for non-squamous non-small-cell lung cancer (ns-NSCLC) and melanoma, and was launched later in Europe for ns-NSCLC only, prior to this expansion.

It allows physicians to determine PD-L1 expression for melanoma patients using a clinically validated test. Having been used to assess PD-L1 expression in the CheckMate -067 trial, the test can now be used as an aid in the assessment of patients for whom Opdivo and Yervoy combination treatment is being considered.

Jacob Thaysen, president of Agilent's diagnostics and genomics group, said: "This important launch enables standardised testing for PD-L1 expression."

Originally launched last month, the test is the first and only diagnostic assay approved to assess the survival benefit associated with Opdivo.