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

Roche

Roche obtains CE certification for VENTANA CLDN18 (43-14A) RxDx Assay to identify patients with gastric and gastroesophageal junction cancer eligible for targeted treatment with VYLOY

15 Oct 2024

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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AntibodiesAntibodies are used in techniques such as confocal and fluorescence microscopy, flow cytometry, ELISA, ELISPOT, immunohistochemistry, western blotting and immunopreciptation. Select specific antigen reactivity, high specific affinity, low non-specific binding, monoclonal or polyclonal, primary or secondary antibodies and associated conjugates such as an enzyme or dye for visualization.BiomarkersBiomarkers are biological markers which can be measured and evaluated to indicate a biological state. The use of biomarkers in research and diagnosis can indicate a normal or disease state or drug response of cells / tissues. Biomarkers include genetic markers, cell surface markers such as antigens, antibodies or receptors and secreted molecules such as cytokines. An assay system is required for identification of biomarkers. :Cellular PathologyCellular Pathology deals with the microscopic analysis of tissue samples and cells. Sample preparation and processing includes fixation, staining, sectioning and slide mounting, using equipment such microtomes and cryostats. In choosing immunohistochemistry and immunocytochemistry kits, consider chromogens, staining method, antibodies, microscopes and imaging.OncologyThe branch of medical science that deals with the diagnosis and treatment of cancer is known as oncology.ImmunohistochemistryImmunohistochemistry (IHC) is a technique used to detect specific proteins in tissue samples by using antibodies that bind to target antigens. IHC is widely applied in pathology, immunology, hematology and cancer diagnostics. Explore IHC tools in our peer-reviewed product directory; compare products, check reviews, and get pricing directly from manufacturers.Cell Staining

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New assay fulfils medical need for patients with gastric or gastroesophageal junction cancer