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Idylla CDx MSI Test

Biocartis NV · Model v3 · UDI-DI 15415219001328

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Description

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).

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.