Idylla™ MSI Assay further strengthens Biocartis’ test menu and offers opportunities to enter the immuno-oncology testing market.

Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announces the launch of its innovative and fully automated Idylla™ MSI1 Assay (RUO2). The Idylla™ MSI Assay provides information on the MSI status3,4,5 (i.e. MSI-High or Microsatellite stable) of a tumor within approximately 150 minutes from just one slice of FFPE6 tumor tissue, without requiring a reference sample.

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. Current MSI testing methods rely on manual, lengthy and complex procedures involving amongst others obtaining and testing of a second reference sample.

The fully automated Idylla™ MSI Assay includes a novel set of seven MSI biomarkers, consisting of short homopolymers located in the ACVR2A, BTBD7, DIDO1, MRE11, RYR3, SEC31A and SULF2 genes. These were exclusively licensed to Biocartis in 2013 from VIB, the life sciences research institute in Flanders (Belgium), and originated from the research of the group of Prof. Diether Lambrechts (VIB-KU Leuven, Belgium).

Several multi-center studies3,4,5 comparing the standard methods7 with the Idylla™ MSI Assay showed a >95% concordance between results. Furthermore, compared to standard methods, the Idylla™ MSI Assay has a significantly lower failure rate3,4,5, provides automated result reporting and includes MSI-specific pan-tumor biomarkers, independent of ethnicity3,4,5.

Herman Verrelst, Chief Executive Officer of Biocartis, commented: “Our fully automated Idylla™ MSI Assay, once validated for diagnostic use, will significantly strengthen our colorectal cancer test menu. This test is expected to overcome the drawbacks of conventional MSI testing, and could as such be made available to a much larger patient population. While the test is planned to initially be launched for colorectal cancer, MSI is present in several other tumor types as well, such as gastric and endometrial cancer, providing additional opportunities going forward. Finally, since MSI is an independent factor that may predict a patient’s response to certain immunotherapies8, we can now further explore opportunities to enter into the field of immuno-oncology9 as the importance of MSI testing in that market is growing.”

Dr. Alexander Mackinnon, Director - Clinical and Translational Research Core Lab at the Medical College of Wisconsin (US), reacted: “Current MSI testing methods are often laborious and difficult to optimize.  Furthermore, conventional MSI testing requires both normal and malignant tumor tissue. The Idylla™ MSI test is a simple, fully automated solution requiring only tumor tissue for the determination of MSI status. It provides rapid results that are highly concordant with conventional testing methods”.

The CE-marking of the Idylla™ MSI Assay for in vitro diagnostic use in colorectal cancer is anticipated in 2019.

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