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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceIdylla CDx MSI Test
Generic NameNucleic Acid Based Assay, Microsatellite Instability
ApplicantBiocartis Us, Inc.
Two Pierce Place
Suite 1510
Itasca, IL 60174
PMA NumberP250005
Date Received02/19/2025
Decision Date08/15/2025
Product Code SFL 
Advisory Committee Molecular Genetics
Clinical TrialsNCT04008030
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
For in vitro diagnostic use. For Prescription Use Only. For use on the Biocartis Idylla System only.The Idylla CDx MSI Test is an in vitro diagnostic test intended for the qualitative detection of a panel of seven monomorphic biomarkers (ACVR2A, BTBD7, DIDO1, MRE11, RYR3, SEC31A and SULF2) for identification of microsatellite instability (MSI) in colorectal cancer (CRC) tissue. The Idylla CDx MSI Test uses formalin-fixed, paraffin embedded (FFPE) tissue sections from patients with CRC, from which nucleic acids are extracted, then analyzed using PCR amplification and subsequent melt-curve analysis. The Idylla CDx MSI Test reports MSI status as either Microsatellite Stable (MSS) or Microsatellite Instability-High (MSI-H) or invalid. The test is intended as a companion diagnostic to identify CRC patients with MSI-H status, who may benefit from treatment with OPDIVO (nivolumab) as a monotherapy and/or treatment with OPDIVO (nivolumab) in combination with YERVOY (ipilimumab).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Labeling
Labeling Part 2
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