Nucleic Acid Based Assay, Microsatellite Instability
Basic Information
- Device Name
- Nucleic Acid Based Assay, Microsatellite Instability
- Trade Name
- Idylla CDx MSI Test
- PMA Number
- P250005
- Device Class
- FDA Class 3
- Product Code
- SFL
- Generic Name
- Nucleic Acid Based Assay, Microsatellite Instability
- Medical Specialty
- Unknown
- Advisory Committee
- Medical Genetics
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- August 15, 2025
- Date Received
- February 19, 2025
- Expedited Review
- N
Advisory Committee 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).
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| SFL | Nucleic Acid Based Assay, Microsatellite Instability | FDA class 3 | Unknown |