Detection of microsatellite instability (MSI) in colorectal cancer samples with a novel set of highly sensitive markers by means of the Idylla MSI Test prototype.

e15639Background: Detection of microsatellite instability (MSI) is currently recommended for all patients with colorectal cancer (CRC). Current clinical reference methods are immunohistochemical staining of mismatch repair proteins and/or PCR analysis of frequently mutated short tandem repeat regions of DNA. The Idylla™ MSI Test prototype is being developed using a new set of short homopolymers capable of faster detection with greater specificity and selectivity compared to current methods. Methods: Prototype Idylla™ MSI Test cartridges were developed up to a finalized design. Repeat length of a novel set of 7 biomarkers was determined on 348 formalin-fixed and paraffin-embedded (FFPE) CRC samples using these prototype tests which allow a complete automated workflow including sample preparation, DNA amplification followed by melting curve analysis and automated interpretation. Patient samples of several clinical sites and different ethnic groups were included to assess robustness of marker selection. All ...