Swiss pharmaceutical giant Roche Group has announced its receipt of the CE Mark for its VENTANA FOLR1 (FOLR1-2.1) RxDx Assay on Monday. This diagnostic tool is designed to identify ovarian cancer patients who qualify for targeted treatment with ELAHERE (mirvetuximab soravtansine).This marks the introduction of the first broadly available immunohistochemistry (IHC) companion diagnostic test in Europe to aid in the identification of epithelial ovarian cancer (EOC) sufferers potentially suitable for ELAHERE’s targeted therapy.Ovarian cancer stands among the most lethal gynecological cancers globally, being the eighth highest cause of cancer-related deaths amongst women. It accounts for 4.7% of all female cancer fatalities. In 2022, ovarian cancer claimed the lives of 46,232 women in Europe and 209,596 women worldwide.ELAHERE represents an innovative antibody-drug conjugate (ADC) therapy, developed by AbbVie, aimed at addressing FR?-positive, platinum-resistant ovarian cancer.The VENTANA RxDx Assay offered by Roche is a qualitative immunohistochemical examination. It employs mouse monoclonal anti-FOLR1 clone FOLR1-2.1 for evaluating folate receptor alpha (FR?) in formalin-fixed, paraffin-embedded epithelial ovarian cancer samples.This latest approval is derived from the findings of the SORAYA6 and MIRASOL7 clinical trials, which included platinum-resistant epithelial ovarian cancer patients who were confirmed as FR?-positive through the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay.Earlier in the year, the VENTANA FOLR1 (FOLR1-2.1) test had obtained pre-authorization in Germany and Austria. This facilitated access for clinicians and patients to the test in those countries prior to achieving CE Mark certification.Jill German, the Head of Pathology Lab at Roche Diagnostics, commented, “This certification empowers us to expand the availability of our cutting-edge diagnostic solutions. The early approval granted in Germany and Austria underscored the pressing demand for this test. Now, clinicians across Europe have a vital resource to swiftly identify ovarian cancer patients eligible for targeted therapy. By enabling more accurate and personalized treatment decisions, we aspire to enhance outcomes for the multitude of women in Europe battling this formidable disease.”The material has been provided by InstaForex Company – www.instaforex.com
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