Roche announced that the 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 tumours of patients with gastric or gastroesophageal junction, GEJ, adenocarcinoma. These patients now may be eligible for treatment with Astellas’ targeted therapy VYLOY. 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.
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