Agilent Expands PD-L1 Test for Esophageal Cancer Under CE-IVD Mark

Agilent Technologies announced an expansion of its CE-IVD marking in Europe for the PD-L1 IHC 28-8 pharmDx test. The diagnostic aid is now approved to identify patients with esophageal squamous cell carcinoma for treatment with Bristol Myers Squibb’s OPDIVO® (nivolumab) immunotherapy.

The expanded use covers patients receiving OPDIVO® in combination with chemotherapy or with YERVOY® (ipilimumab). This provides a targeted treatment option for patients with this specific cancer type, which is the seventh most common globally and the sixth leading cause of cancer death.

PD-L1 is a key biomarker for predicting response to anti-PD-1 therapies. The Phase 3 CheckMate-648 trial results indicated the efficacy of these combined treatments for patients with tumor cell PD-L1 expression of 1% or higher.

Agilent Technologies serves as a global leader in partnering with pharmaceutical companies to develop immunohistochemistry (IHC)-based diagnostics for targeted cancer therapies. This expansion underscores the company's commitment to advancing cancer diagnostics and treatment.