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.
Specimen Requirements
Preferred specimen (FFPE block):
A formalin-fixed, paraffin-embedded (FFPE) tissue block is the preferred specimen type. Use 10% NBF fixative; do not use zinc or mercury fixatives.
If submitting slides (instead of a block):
Submit the following. All slides cut at 4–5 microns. Please use positively-charged slides and 10% NBF fixative.
H&E slide: One (1) unbaked, unstained slide for H&E staining (required)
Cut Slides: Two (2) positively charged unstained slides for each IHC test/antibody ordered
Specimen adequacy:
Tissue submitted must have >100 viable tumor cells present.
Specimen identification:
Block and slide identifiers should be clearly written and match exactly with the specimen ID and specimen labeling as noted on the requisition.
