Agilent companion diagnostic expands ce-ivd mark in europe to include head and neck squamous cell carcinoma (hnscc)

Agilent technologies inc. announced that its pd-l1 ihc 22c3 pharmdx assay is now labeled for use in hnscc in the european union. the assay is ce-ivd–marked as an aid in identifying hnscc patients for treatment with keytruda, an anti-pd-1 therapy manufactured by merck (known as msd outside the united states and canada). keytruda, as monotherapy or in combination with platinum and 5-fluorouracil (5-fu) chemotherapy, is indicated for the first-line treatment of metastatic or unresectable recurrent hnscc in adults whose tumors express pd-l1 with a cps = 1. pd-l1 ihc 22c3 pharmdx is the only clinical trial-proven pd-l1 assay ce-ivd–marked as an aid in identifying hnscc patients for treatment with keytruda. pd-l1 ihc 22c3 pharmdx is now ce-ivd–marked as a companion diagnostic to keytruda in three tumor indications – nsclc, urothelial carcinoma, and hnscc. in the united states, the fda approved pd-l1 ihc 22c3 pharmdx in a hnscc indication in june.
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