Roche Holding AG (RHHBY) Thursday said it received CE mark approval for the first companion diagnostic test, VENTANA CLDN18 (43-14A) RxDx Assay aimed to identify patients with gastric and gastroesophageal junction cancer who may be eligible for treatment with Astellas' targeted therapy Vyloy.
According to National Cancer Institute, companion diagnostic test is used to help match a patient to a specific drug or therapy.
The approval is based on the results from SPOTLIGHT and GLOW clinical studies. In these studies, approximately 38 percent of gastric/GEJ cancer patients were considered CLDN18.2 positive by the VENTANA CLDN18 (43-14A) RxDx Assay. CLDN18.2 is an emerging biomarker in gastric and GEJ cancers and helps predict the likelihood of response to targeted therapy. Current guidelines for gastric/GEJ cancer recommend using biomarkers to guide therapeutic decision making.
"By identifying those who may benefit from a targeted treatment, this new test can expand treatment possibilities, and aid clinicians to potentially improve outcomes," said Matt Sause, CEO of Roche Diagnostics.
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