NEW YORK – Roche on Monday announced that its Ventana FOLR1 (FOLR1-2.1) RxDx assay has received CE marking for use as a companion diagnostic with Abbvie's Elahere (mirvetuximab soravtansine) in patients with ovarian cancer.
The qualitative immunohistochemistry assay detects the folate receptor 1 protein (FOLR1), which is overexpressed in most ovarian cancers, in formalin-fixed, paraffin embedded epithelial ovarian cancer tissue specimens. The test can be used to identify epithelial ovarian cancer patients who may be eligible for targeted treatment with Elahere, an antibody-drug conjugate for the treatment of FOLR1-positive platinum-resistant ovarian cancer, Roche said in a statement.
The assay uses Roche's OptiView DAB IHC Detection Kit for staining on the firm's BenchMark Ultra instrument.
Earlier this year, the test received pre-authorization in Germany and Austria, which allowed clinicians in those countries to use the assay before it received CE marking.
"This certification will allow us to extend the reach of our innovative diagnostic solutions," said Jill German, head of pathology lab at Roche Diagnostics. "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 personalized treatment decisions, we hope this may help improve outcomes for the many women in Europe facing this devastating disease."
Elahere received marketing authorization from the European Commission this week.