Identity
- Trade Name
- VENTANA FOLR1 (FOLR-2.1) RxDx Assay FDA PMA
- Generic Name
- Immunohistochemistry Assay, Antibody, FOLR1 FDA PMA
Identifiers
- PMA Number
- P220006 FDA PMA
- FDA Product Code
- QUL FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Legislation / Framework
- 21 CFR Part 864.1860 FDA PMA
- Regulation Number
- 864.1860 FDA PMA
- Advisory Committee
- Medical Genetics FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The VENTANA FOLR1 (FOLR1-2.1) RxDx Assay is a qualitative immunohistochemical assay classified as an antibody-based test for folate receptor alpha (FOLR1). It uses a mouse monoclonal anti-FOLR1 antibody, clone FOLR1-2.1, to detect FOLR1 protein expression in formalin-fixed, paraffin-embedded tissue samples from epithelial ovarian, fallopian tube, or primary peritoneal cancers. Results are evaluated via light microscopy to assess membrane staining intensity and distribution in viable tumor cells, with a clinical cutoff of ≥75% positive cells at moderate or strong intensity levels.
This assay is designed for in vitro diagnostic use and requires the OptiView DAB IHC Detection Kit for staining on a BenchMark ULTRA instrument. It is intended for laboratory use only and must be interpreted by a qualified pathologist alongside histological examination and clinical information. The device is supplied as a single-use reagent and is regulated under FDA Premarket Approval (PMA) as a Class III medical device (PMA Number: P220006). No additional sterility or MRI safety information is specified.
Frequently asked questions
What types of cancer tissue samples can the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay detect folate receptor alpha (FOLR1) protein expression in?
The assay is specifically designed to detect FOLR1 protein expression in formalin-fixed, paraffin-embedded tissue samples from epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. It is not intended for use with other tissue types or cancer types.
How is the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay performed, and what equipment is required?
The assay uses a mouse monoclonal anti-FOLR1 antibody (clone FOLR1-2.1) and requires the OptiView DAB IHC Detection Kit for staining. It must be run on a BenchMark ULTRA instrument, and results are evaluated via light microscopy by a qualified pathologist to assess membrane staining intensity and distribution in viable tumor cells.
Is the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay intended for single-use or repeated use, and how is it supplied?
The assay is supplied as a single-use reagent, meaning each kit is designed for one use only. This ensures consistency and reliability in testing, as reuse is not supported or recommended.
What clinical significance does the FOLR1 expression cutoff (≥75% viable tumor cells with moderate or strong membrane staining) hold for patients?
The assay’s clinical cutoff of ≥75% viable tumor cells with moderate or strong membrane staining helps identify patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer who may be eligible for treatment with ELAHERE (mirvetuximab soravtansine). Results should always be interpreted by a pathologist alongside histological examination and clinical information.
Who is authorized to perform and interpret the results of the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay?
The assay is intended for in vitro diagnostic use in a laboratory setting only and must be performed and interpreted by a qualified pathologist. Interpretation requires combining assay results with histological examination and relevant clinical information to guide patient management.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: VENTANA® FOLR1 (FOLR1-2.1) RxDx Assay, Predictive IHC assay, FDA, VENTANA FOLR1 (FOLR1-2.1) RxDx Assay - elabdoc-prod.roche.com, PDF VENTANA FOLR1 (FOLR1-2.1) RxDx Assay Interpretation Guide for ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P220006 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ventana Medical Systems, Inc.
Sources (1)
- FDA PMA P220006 24 fields · synced Oct 6, 2026