PMA P250005
- Device
- Idylla CDx MSI Test
- Applicant
- Biocartis Us, Inc.
- PMA number
- P250005
- Product code
- SFL
- Decision date
- 2025-08-15
- Classification
- Medical Genetics
- Generic name
- Nucleic Acid Based Assay, Microsatellite Instability
- 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).
Current openFDA PMA Record#
- Device
- Idylla CDx MSI Test
- Applicant
- Biocartis Us, Inc.
- PMA number
- P250005
- Product code
- SFL
- Generic name
- Nucleic Acid Based Assay, Microsatellite Instability
- Decision date
- 2025-08-15
- Decision code
- APPR
- Date received
- 2025-02-19
- 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).