Roche: CE certification for gastric cancer test

(CercleFinance.com) - Roche has obtained CE certification for the first companion diagnostic to identify patients with gastric or gastroesophageal junction cancer eligible for targeted treatment with VYLOY.


Its new RxDx VENTANA CLDN18 (43-14A) test thus meets an unmet medical need by enabling clinicians to identify patients with these types of cancer who could benefit from a targeted treatment option.

The approval is based on the results of the SPOTLIGHT and GLOW studies, which demonstrated the test's ability to determine CLDN18 protein expression, an emerging biomarker in these cancers that helps predict the likelihood of response to targeted therapy.


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