Idylla CDx MSI Test
FDA premarket approval P250005 · decided 2025-08-15
Approval details
- PMA number
- P250005
- Trade name
- Idylla CDx MSI Test
- Generic name
- Nucleic Acid Based Assay, Microsatellite Instability
- Applicant
- Biocartis Us, Inc.
- Date received
- 2025-02-19
- Decision date
- 2025-08-15
- Days to decision
- 177 days
- Decision code
- APPR
- Product code
- SFL
- Advisory committee
- Medical Genetics
- Expedited review
- No
- Location
- Itasca, IL
- 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 whic
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