Roche has secured CE mark approval for its immunohistochemistry (IHC) companion diagnostic test, VENTANA FOLR1 (FOLR1-2.1) RxDx Assay, for the identification of epithelial ovarian cancer (EOC) patients suitable for targeted therapy with AbbVie’s ELAHERE (mirvetuximab soravtansine).
This is the first test to be broadly available in Europe, offering a new resource for detecting folate receptor alpha (FRɑ).
The CE mark for the VENTANA FOLR1 RxDx Assay follows earlier pre-authorisation in Austria and Germany which provided early access to the test for clinicians and patients in those countries.
This qualitative IHC assay utilises the monoclonal anti-folate receptor 1 protein (FOLR1) clone FOLR1-2.1 of a mouse.
It is also designed for use in evaluating FRɑ in formalin-fixed, paraffin-embedded EOC tissue specimens, along with fallopian tube and primary peritoneal cancers, through light microscopy.
Roche Diagnostics Pathology Lab head Jill German said: "This certification will allow us to extend the reach of our innovative diagnostic solutions.
"The early exemption approval in Germany and Austria highlighted the urgent need for this test. Now, clinicians across Europe can access a critical tool to quickly identify ovarian cancer patients who may be eligible for targeted therapy.
“By enabling more precise and personalised treatment decisions, we hope this may help improve outcomes for the many women in Europe facing this devastating disease."
Data from the clinical studies SORAYA and MIRASOL supported the approval.
These studies enrolled patients with platinum-resistant EOC who were determined to be FRɑ-positive using the VENTANA FOLR1 RxDx Assay. FOLR1, also known as FRɑ, is expressed in approximately 90% of ovarian carcinomas.
The company made VENTANA FOLR1 RxDx Assay available in CE countries.
Last month, the company gained CE mark approval for VENTANA CLDN18 (43-14A) RxDx assay to identify patients with gastric or gastroesophageal junction (GEJ) adenocarcinoma eligible for targeted therapy with Astellas’ VYLOY.
