Roche announced that it has received the CE Mark under the European Union's In Vitro Diagnostic Regulation for its companion diagnostic (CDx) test, which is designed to aid in identifying ovarian cancer patients eligible for targeted treatment with Abbvie's antibody-drug conjugate therapy Elahere.
The Ventana FOLR1 (FOLR1-2.1) RxDx Assay is an immunohistochemistry (IHC) CDx that detects the folate receptor 1 protein (FOLR1 or FRɑ), which is overexpressed in most ovarian cancers. Folate receptor 1 protein (FOLR1), also known as folate receptor alpha (FRɑ), may be overexpressed in ovarian cancers and is expressed at some level in approximately 90% of ovarian carcinomas. It therefore serves as a predictive biomarker for FOLR1-targeted therapy for ovarian cancer.
It is the first such IHC diagnostic to be approved for use in identifying patients who might be eligible for treatment with Elahere, which is indicated for the treatment of patients with FRɑ-positive platinum-resistant ovarian cancer, said Roche in a statement. Roche also noted that the CE Mark was granted following an early exemption approval for the assay in Germany and Austria earlier this year.
