The VENTANA FOLR1 (FOLR1-2.1) RxDx Assay is an FDA-approved qualitative immunohistochemical assay using a mouse monoclonal anti-FOLR1 antibody intended for use in the assessment of Folate Receptor alpha (FRα) protein in formalin-fixed, paraffin-embedded (FFPE) ovarian cancer tissue on a VENTANA BenchMark ULTRA instrument. FOLR1 is indicated as an aid in identifying patients with ovarian cancer (including epithelial ovarian cancer, primary peritoneal cancer or primary fallopian tube cancer), whose tumors have FRα expression in ≥75% tumor cells staining at 2+/3+ intensity, who are eligible for treatment with ELAHERE™ (mirvetuximab soravtansine-gynx).
This test is available through the ImmunoGen-sponsored FOLR1 testing program initiative called FR-ASSIST™. A separate test request form is required. Please visit the FOLR1 Ovarian Cancer Testing Program page for more information and to download the Test Request Form.
The FRα protein is expressed in 90% of ovarian cancers and has limited expression in normal tissue, making it an attractive therapeutic target. In using the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay for the evaluation of ovarian cancer patients, approximately 35% of patients are considered to have high expression of FRα—as defined by the scoring criteria mentioned above— and thus eligible for treatment with ELAHERE™.
- Ovarian cancer (including epithelial ovarian cancer, primary peritoneal cancer and primary fallopian tube cancer) tissue is required.
- A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type
- One (1) unbaked, unstained slide for H&E staining (required) and two to three (2-3) positively charged unstained slides (all cut at 4-5 microns) for each test/antibody ordered
- Block and slide identifiers should be clearly written and match exactly with the specimen ID and specimen labeling as noted on the requisition.
Use cold pack for transport. Make sure cold pack is not in direct contact with specimen.
1. VENTANA FOLR1 (FOLR1-2.1) RxDx Assay. Package insert. Roche; 2022.
2. ELAHERE. Package insert. ImmunoGen, Inc.; 2022.