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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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DeviceCRCDx RAS Mutation Detection Assay Kit
Generic NameSomatic gene mutation detection system
ApplicantEntroGen, Inc.
20950 Warner Center Lane, Suite B
Woodland Hills, CA 91367
PMA NumberP220005
Date Received04/20/2022
Decision Date09/29/2023
Product Code OWD 
Advisory Committee Pathology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the CRCdx® RAS Mutation Detection Kit. The device is a qualitative real-time PCR in vitro diagnostic test intended for the detection of 35 variants of KRAS and NRAS exon 2, 3, 4 somatic mutations in genomic DNA extracted from formalin-fixed, paraffin-embedded (FFPE) colorectal cancer (CRC) tissue samples. The test is intended as a companion diagnostic (CDx) to aid in the identification of colorectal cancer (mCRC) patients who may benefit from treatment with Vectibix (panitumumab) based on a no mutation detected test result in accordance with the approved therapeutic product labeling.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness