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 sevenmonomorphic biomarkers (ACVR2A, BTBD7, DIDO1, MRE11, RYR3, SEC31A and SULF2) for identification ofmicrosatellite 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, thenanalyzed using PCR amplification and subsequent melt-curve analysis. The Idylla CDx MSI Test reports MSIstatus 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 benefitfrom treatment with OPDIVO (nivolumab) as a monotherapy and/or treatment with OPDIVO (nivolumab) incombination with YERVOY (ipilimumab).
A collection of reagents and other associated materials intended to be used for determining microsatellite instability [abnormal repeated sequences of deoxyribonucleic acid (DNA)] within a tumour tissue specimen, using a nucleic acid technique (NAT). This phenomenon which is associated with defective DNA mismatch repair genes is a feature of certain cancer types including hereditary nonpolyposis colon cancer (HNPCC).