Predictive IHC assay
The VENTANA FOLR1 (FOLR1-2.1) RxDx Assay is the first and only immunohistochemistry (IHC) assay FDA approved to identify epithelial ovarian cancer (EOC) patients eligible for FOLR1-targeted treatment with ELAHERE (mirvetuximab soravtansine).
Ovarian cancer is the fifth overall cause for cancer death in women, representing 5% of all cancer deaths in women.1 It is also the deadliest of gynecological cancers: in 2017, 14,080 women in the US2 and in 2018, 44,576 women in Europe3 died from ovarian cancer. Most women with ovarian cancer present with Stage III or IV disease, contributing to its high mortality rate.4
The folate receptor 1 protein (FOLR1), also commonly known as folate receptor alpha (FRα), is a 38-40 kDA glycosylphosphatidylinositol (GPI)-anchored cell surface protein encoded by the FOLR1 gene.6 FOLR1 expression is largely restricted to malignant tumors compared to normal tissue, particularly epithelial ovarian cancer (EOC), endometrial cancer, non-small cell lung carcinoma and renal cell cancer. Consequently, FOLR1 is frequently exploited as a target for specific delivery of chemotherapy and immunotherapy agents.7
VENTANA FOLR1 (FOLR1-2.1) RxDx Assay is a qualitative immunohistochemical assay using mouse monoclonal anti-FOLR1 clone FOLR1-2.1 intended for use in the assessment of folate receptor alpha (FOLR1) in formalin-fixed, paraffin-embedded epithelial ovarian, fallopian tube, or primary peritoneal cancer tissue specimens by light microscopy. This assay is for use with OptiView DAB IHC Detection Kit for staining on a BenchMark ULTRA instrument.
FOLR1 expression clinical cut-off is ≥ 75% viable tumor cells (TC) with membrane staining at moderate and/or strong intensity levels.
This 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).
Test results of the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls.
This product is intended for in vitro diagnostic (IVD) use.