Tuesday November 17th 2020



Biocartis Group NV, an innovative molecular diagnostics company, announces the publication of a global multi-center real world study with its Idylla™ MSI Assay. This multi-center study is the largest so far for Biocartis and demonstrates excellent performance of the Idylla™ MSI Assay with a very low failure rate.

In this real-world global study, 44 clinical centers performed Idylla™ MSI testing on 1,301 archived colorectal cancer FFPE tissue sections. Idylla™ results were compared against routine diagnostic testing in those sites, demonstrating excellent concordance with immunohistochemistry (96%) and routine molecular methods (98%). Additionally, the failure rate of the Idylla™ MSI Assay was very low (0.23%; 3/1301), underlining the robustness of the Idylla™ MSI Assay.

Microsatellite instability (MSI) is the result of inactivation of the body’s so-called DNA mismatch repair (MMR) system. Consequently, errors that normally spontaneously occur during DNA replication are no longer corrected, contributing to tumor growth and evolution. Microsatellite instability (MSI) is present in 15–20% of primary colorectal cancers and MSI status is assessed to detect Lynch syndrome, guide adjuvant chemotherapy, determine prognosis, and use as a companion test for checkpoint blockade inhibitors. Traditionally, MSI status is determined by immunohistochemistry or molecular diagnostic testing methods. Although it is recommended for all colorectal, endometrial and several other cancers, MSI testing remains underused today since current methods are highly complex.

The fully automated Idylla™ MSI Test (CE-IVD) was developed to overcome these drawbacks and provides information on the MSI status within approximately 150 minutes from just one slice of FFPE tumor tissue, without the need for a reference sample.

Herman Verrelst, Chief Executive Officer of Biocartis, commented: “We are pleased with this very large and strong data set for our Idylla™ MSI Test. MSI is increasingly used as a biomarker that guides therapies or determines prognosis for a growing number of cancers. We believe that the unique aspects of the Idylla™ MSI Test, which clearly shows great advantages over current MSI testing methods on the market, could enable a broader penetration of MSI testing. Very large, global studies such as these really contribute to show the unique features of our Idylla™ MSI Test.”

The study is published in Virchows Archive and is available online here. The Idylla™ MSI Test received its CE-marking on 28 February 2019. For more info, go to the Biocartis website.