Roche receives FDA approval for Ventana CLDN18 RxDx Assay

Roche (RHHBY) announced that the VENTANA CLDN18 RxDx Assay is the first U.S. Food and Drug Administration approved immunohistochemistry companion diagnostic for determining CLDN18 protein expression in tumours of patients with gastric or gastroesophageal junction adenocarcinoma. These patients now may be eligible for treatment with Astellas’ targeted therapy VYLOY. “Patients who are diagnosed with gastric or gastroesophageal junction cancer are often diagnosed in an advanced stage as early symptoms can be similar across several conditions,” said Jill German, Head of Pathology Lab at Roche Diagnostics. “Our companion diagnostic for CLDN18 can help identify patients eligible for targeted treatment and provide them with additional therapeutic options. With the launch of this test, Roche continues to advance personalised healthcare by expanding our innovative companion diagnostic portfolio.”