Roche receives CE Mark for Ventana FOLR1 RxDx Assay

Roche (RHHBY) announced that it has received CE Mark for its Ventana FOLR1 RxDx Assay. This is the first immunohistochemistry, or IHC, companion diagnostic test to be made widely available in Europe to aid in identifying epithelial ovarian cancer, or EOC, patients who may be eligible for targeted treatment with Elahere. Elahere is an antibody-drug conjugate therapy developed by AbbVie for the treatment of FRa-positive platinum-resistant ovarian cancer. This certification follows the news earlier this year that the Ventana FOLR1 test had received pre-authorization in Germany and Austria. This exceptional decision allowed clinicians and patients in these countries to access the test ahead of the CE Mark certification.