Agilent Technologies has received the CE mark for expanded use of its Dako PD-L1 IHC 28-8 pharmaDx test for squamous cell carcinoma of the head and neck (SCCHN). This assay detects the expression of programmed death ligand-1 (PD-L1) in tumors in patients with SCCHN. It involves staining a small piece of the tumor removed during biopsy to reveal the presence of PD-L1, a protein associated with suppression of the immune system. If the test shows that PD-L1 is expressed, then the patient could benefit from treatment with Opdivo (nivolumab), an immunotherapy that helps restore T-cell antitumor function.
The test had previously received the CE mark for tumor PD-L1 expression for non-squamous, non-small-cell lung cancer, and melanoma. With this expanded authorization, it will be the first diagnostic assay that helps determine whether patients with SCCHN might respond to Opdivo. Agilent is also awaiting approval for expanded use in other countries.