CE Mark Approval for Roche’s Diagnostic Test in Gastric Cancer Therapy

Roche announced the approval of its VENTANAⓇ CLDN18 (43-14A) RxDx Assay, now CE Mark certified for identifying CLDN18 protein expression in gastric and gastroesophageal junction (GEJ) adenocarcinoma. This test allows clinicians to determine which patients may benefit from Astellas' VYLOYTM (zolbetuximab), the first treatment targeting CLDN18.2-positive tumours. The approval marks a significant step forward in personalized treatment for gastric cancer.

According to Roche, current guidelines recommend biomarker-based diagnostics to guide cancer treatment. The new assay can pinpoint patients whose tumours exhibit the CLDN18.2 protein, making them eligible for zolbetuximab therapy. This advancement expands therapeutic possibilities for a cancer type often diagnosed late and associated with low survival rates, especially in Europe.

Gastric cancer is the fifth most common cancer globally, with poor survival rates due to late diagnosis. The VENTANA CLDN18 test is based on clinical studies showing improved outcomes when pairing zolbetuximab with chemotherapy. Patients identified as CLDN18.2-positive experienced a significant reduction in disease progression, potentially improving their treatment prospects.

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