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) who may be eligible for targeted therapy treatment.
Note: This test should be used for patient specimens that have already utilized the FOLR1 Sponsored Testing Program, have multiple specimens to test, or want to use in off-indication specimens.
If interested in utilizing the Sponsered Testing Program, 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.
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.
- For evaluation, tissue submitted must have ≥100 viable tumor cells present.
Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen.
Global: 48 hours, Tech-Only (stain only): 24 hours