Evaluation of a Fully Automated Idylla Test System for Microsatellite Instability in Colorectal Cancer

Abstract

Background: Microsatellite instability (MSI) is a phenotype commonly observed in colorectal cancer, and is caused by a deficient mismatch repair system. Determining MSI status greatly aids tumor prognosis and treatment plans in colorectal cancer, and plays a critical role in recent United States Food and Drug Administration-approved immunotherapies. As recognition of its importance grows, MSI has been identified in more types of cancers, underscoring the importance of accurate assays for determining MSI status in tumor cells. Currently, tumor MSI status is detected via polymerase chain reaction-based methods or immunohistochemistry.

Materials and methods: In this study, we tested a new, fully automated MSI detection system (Idylla MSI detection kit) released by Biocartis. We evaluated 42 formalin-fixed paraffin-embedded tumor tissues, which were clinically tested for MSI status using the polymerase chain reaction or immunohistochemistry method, with the Idylla MSI detection system.

Results: The Idylla MSI detection system showed an overall 97.62% concordance rate with previously used methods. Moreover, this fully automated system requires less than 5 minutes "hands on" preparation time and 150 minutes total run time per sample.

Conclusion: The Biocartis Idylla MSI kit proves a powerful tool to accurately detect MSI status in tumor cells in a rapid and almost labor-free manner.

Keywords: Colorectal Cancer; FFPE; Immunotherapies; Mismatch repair; Rapid detection.