VENTANA FOLR1 (FOLR1-2.1) RxDx Assay - Immunohistology cell marker IVDs

Intended purpose

Intended for laboratory use in the assessment of folate receptor alpha (FOLR1) protein in formalin-fixed, paraffin-embedded epithelial ovarian, fallopian tube, or primary peritoneal cancer tissue specimens stained on a BenchMark IHC/ISH instrument. The assay is indicated as an aid in identifying patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer who may be eligible for treatment with ELAHERE (mirvetuximab soravtansine) in accordance with the approved therapeutic product labelling.

Functional description

The assay is indicated as an aid in identifying patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer who may be eligible for treatment with ELAHERE (mirvetuximab soravtansine) in accordance with the approved therapeutic product labelling