Novel diagnostic assay for gastric and gastroesophageal junction cancer receives CE Mark approval

VENTANA CLDN18 (43-14A) RxDx Assay is the first immunohistochemistry (IHC) companion diagnostic test to receive CE Mark approval for determining CLDN18 protein expression in tumors of patients with gastric or gastroesophageal junction (GEJ) adenocarcinoma. These patients may now be eligible for treatment with Astellas’ targeted therapy VYLOY™ (zolbetuximab).

Current guidelines for gastric/GEJ cancer recommend using biomarkers to guide therapeutic decision making. The new VENTANA CLDN18 (43-14A) RxDx Assay can help determine CLDN18.2 status and inform clinicians about the likelihood of patients benefiting from CLDN18.2 targeted therapy. VYLOY™ specifically targets CLDN18.2-positive gastric/GEJ cancer, expanding options for patients to receive therapies appropriate for their specific disease.

“Gastric cancer remains a significant global health challenge. In Europe, only three percent of patients with metastatic disease live beyond five years," said Matt Sause, CEO of Roche Diagnostics. "Our new companion diagnostic is a significant step forward for patients. By identifying those who may benefit from a targeted treatment, this new test can expand treatment possibilities, and aid clinicians to potentially improve outcomes.”

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