# VENTANA FOLR1 (FOLR-2.1) RxDx Assay

Source: https://onco.cc/drugs/ventana-folr1-rxdx/  
OnCo record `ventana-folr1-rxdx` (Test). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The stain that selects people with ovarian, fallopian tube or primary peritoneal cancer for mirvetuximab soravtansine.

## Summary

Ventana Medical Systems' (Roche Tissue Diagnostics) FOLR1 (FOLR-2.1) RxDx Assay was approved on 14 November 2022 (PMA P220006) as the companion diagnostic for mirvetuximab soravtansine in epithelial ovarian, fallopian tube or primary peritoneal cancer with folate receptor alpha expression.

## Fields

- Kind: Test
- Status: approved
- Last checked: 2026-11-03
- Also known as: VENTANA FOLR1 (FOLR1-2.1) RxDx Assay; Ventana FOLR1 (FOLR-2.1) RxDx Assay
- Tags: test
- Brand: VENTANA FOLR1 RxDx Assay
- Modality: Immunohistochemistry companion diagnostic assay (folate receptor alpha, ovarian tumour tissue)
- Mechanism: Immunohistochemistry for folate receptor alpha (FOLR1) protein in tumour tissue.
- Approvals: US 2022: Companion diagnostic for mirvetuximab soravtansine in epithelial ovarian, fallopian tube or primary peritoneal cancer (FOLR1 protein expression)

## Sources

- FDA PMA P220006: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P220006
- FDA: List of cleared or approved companion diagnostic devices: https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools

## Connected records

- biomarkers: [Folate receptor alpha expression (FRα-positive, PS2+ >= 75%)](https://onco.cc/biomarkers/folr1-expression/)
- cancers: [Ovarian cancer](https://onco.cc/cancers/ovarian/)
- technologies: [Companion diagnostics](https://onco.cc/technologies/companion-diagnostic/), [Histopathology & immunohistochemistry](https://onco.cc/technologies/histopathology-ihc/)
- targets: [Folate receptor alpha](https://onco.cc/targets/folr1/)
- drugs: [Mirvetuximab soravtansine](https://onco.cc/drugs/mirvetuximab-soravtansine/)
- companies: [Roche / Genentech](https://onco.cc/companies/roche-genentech/)
- terms: [Companion diagnostic](https://onco.cc/terms/companion-diagnostic-term/), [Immunohistochemistry (IHC)](https://onco.cc/terms/ihc/)

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