FOLR1/FRα
Companion Diagnostic
FOLR1/FRα is an FDA-approved companion diagnostic used to help identify patients who may be eligible for targeted therapies.
Use
The FOLR1/FRα test is an immunohistochemical (IHC) assay that assesses Folate Receptor alpha (FRα) protein expression in FFPE tumor tissue from patients with epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. The result aids clinicians in identifying patients whose tumors exhibit sufficient FRα expression (≥75% tumor cells with moderate/strong staining) to support eligibility for mirvetuximab soravtansine-gynx (ELAHERE®) targeted therapy. Results should be interpreted in conjunction with histopathology and clinical context to guide personalized treatment selection and planning.
Special Instructions
Patient Eligibility Criteria: FOLR1/FRα immunohistochemistry (IHC) testing can be ordered for: Order the FOLR1/FRα test via the laboratory’s test request form. A tumor specimen collection kit may be sent to the pathology lab. Submit a FFPE tumor block or unstained slides prepared from FFPE tissue that contain adequate tumor cellularity. Follow provided collection and shipping instructions to maintain sample integrity. Results are typically returned within ~7 days of sample receipt.
Limitations
This is a predictive biomarker assay, not a broad diagnostic test; it does not diagnose cancer or provide genomic variant profiles. Results are valid only for the indicated tumor types and for samples with adequate tumor nuclei. The test’s value depends on correct IHC staining and interpretation by a qualified pathologist; technical artifacts or low tumor content may compromise results. Test availability and eligibility criteria may vary by region and clinical program status; the test may be offered under sponsored programs with eligibility requirements.
FDA ApprovedCompanion Diagnostic
Methodology
Immunoassay (IHC)
Biomarkers
Result Turnaround Time
7 days
Related Documents
For more information, please review the documents below
Specimen
Tissue (FFPE)
Volume
FFPE tumor block (preferred)
Minimum Volume
Unstained slide sections prepared on positively charged slides at 4 μm thickness.
Collection Instructions
Submit FFPE tumor tissue with adequate tumor cellularity (50–100 tumor nuclei typically required). Slides must be unstained, positively charged, and prepared per lab instructions.
Causes for Rejection
Insufficient tumor, inappropriate fixation, or damaged samples