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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
DeviceVENTANA FOLR1 (FOLR-2.1) RxDx Assay
Generic NameImmunohistochemistry Assay, Antibody, FOLR1
Regulation Number864.1860
ApplicantVentana Medical Systems Inc.
1910 E. Innovation Park Drive
Tucson, AZ 85755
PMA NumberP220006
Date Received04/25/2022
Decision Date11/14/2022
Product Code QUL 
Docket Number 22M-2869
Notice Date 11/18/2022
Advisory Committee
Clinical TrialsNCT04296890
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay. The device is a qualitative immunohistochemical assay using mouse monoclonal anti-FOLR1, clone FOLR1-2.1, intended for use in the assessment of folate receptor alpha (FOLR1) protein in formalin-fixed, paraffin-embedded epithelial ovarian, fallopian tube or primary peritoneal cancer tissue specimens by light microscopy. This assay is for use with OptiView DAB IHC Detection Kit for staining on a BenchMark ULTRA instrument.FOLR1 expression clinical cut-off is >= 75% viable tumor cells (TC) with membrane staining at moderate and/or strong intensity levels.This assay is indicated as an aid in identifying patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer who may be eligible for treatment with ELAHERE (mirvetuximab soravtansine). Test results of the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls.This product is intended for in vitro diagnostic (IVD) use.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Supplements:  S004 S005 S001 S002