Biocartis Group NV (the ‘Company‘ or ‘Biocartis‘), an innovative molecular diagnostics company, announced the signing of a collaboration agreement with Bristol-Myers Squibb Company, a global biopharmaceutical company, aimed at the potential registration as a companion diagnostic and use of the IdyllaTM MSI test in connection with immuno-oncology therapies.
MSI (‘Microsatellite Instability’) is the result of inactivation of the body’s so-called DNA mismatch repair (MMR) system. Consequently, errors that spontaneously occur during the normal process of DNA replication are no longer corrected, contributing to tumor growth and evolution. Understanding a person’s MSI status may therefore be important for patient care. MSI-High status is found in various types of tumors, including approximately 15% of colorectal (CRC) tumors. In addition to applications for CRC, MSI is believed to be an independent factor that may predict a patient’s response to certain immunotherapies.
Bristol-Myers Squibb’s Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) is the first immuno-oncology combination treatment approved by the US Food and Drug Administration (FDA) for MSI-High or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with certain chemotherapies.
The fully automated IdyllaTM MSI test, that received CE-IVD marking on February 28, 2019, provides information on the MSI status of CRC tumors within approximately 150 minutes from just one slice of FFPE tumor tissue, without the need of a reference sample.
The collaboration agreement allows for joint developments and registrations of the IdyllaTM MSI test for use in a variety of indications, commercial settings and geographies. The first focus under the agreement is expected to be the registration in the United States of the IdyllaTM MSI test as a companion diagnostic test in mCRC.
Herman Verrelst, CEO of Biocartis, commented: “We are proud to announce a collaboration with Bristol-Myers Squibb, one of the world in the area of immuno-oncology therapies. It is our belief that because of the advantages of our IdyllaTM MSI test, MSI testing can potentially be made available to a broader patient population. This could open doors for a lot more patients to benefit from immunotherapies, matching the mission of Biocartis to make personalized medicine a reality.”
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