Biocartis Group NV: Biocartis announces CE-IVD marking of its Idylla(TM) MSI Test

Biocartis NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART), announces the CE-IVD marking of its fully automated Idylla(TM) MSI Test which allows for fast and accurate information on a patient’s MSI status directly from a single sample of FFPE colorectal cancer tumor tissue. This CE-IVD launch is a key addition to Biocartis’ colorectal cancer (CRC) Idylla(TM) test menu as MSI detection is currently recommended for all patients with CRC.

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. MSI-High status is found in about 15% of CRC tumors. About 16% of these MSI-High colorectal cancers may be associated with Lynch Syndrome, which is one of the most common hereditary cancer syndromes and results in a significantly increased risk of developing CRC or other cancers such as endometrial or breast cancer.

MSI testing is recommended for all colorectal and endometrial cancers but is still underused since current methods are highly complex. The Idylla(TM) MSI Test has been developed to overcome these drawbacks. It is a fully automated test that provides information on the MSI status (i.e. Microsatellite Instability-High (MSI-H) or Microsatellite Stable (MSS)) of CRC tumors within approximately 150 minutes from just one slice of FFPE tumor tissue, without the need of a reference sample. The test shows high concordance (>97%) and lower failure rates compared to standard methods. The unique aspects of the Idylla(TM) MSI Test could enable a broader penetration of MSI testing.

Herman Verrelst, Chief Executive Officer of Biocartis, commented: “We are excited to announce the CE-IVD marking of the Idylla(TM) MSI Test which is now available for clinical use in CRC patients. This test truly matches the mission of Biocartis to make innovative MDx testing accessible to all patients worldwide. Thanks to the unique features of this test, MSI testing is now easy, rapid and accessible to a much larger patient population.”

In addition to applications for CRC, MSI is believed to be an independent factor that may predict a patient’s response to certain immunotherapies. As such, expansion opportunities for the Idylla(TM) MSI Test into that domain will be explored in the future.