MECHELEN, Belgium—On March 12, Biocartis Group NV, a molecular diagnostics company, announced the signing of a collaboration agreement with Bristol-Myers Squibb Co. that is aimed at the use of the Idylla MSI test—and its potential registration as a companion diagnostic—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 percent 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 U.S. Food and Drug Administration for MSI-High or mismatch repair-deficient metastatic colorectal cancer that has progressed following treatment with certain chemotherapies.
The fully automated Idylla MSI test, which received CE-IVD marking in the European Union on Feb. 28, 2019, provides information on the MSI status of CRC tumors within approximately 150 minutes from just one slice of FFPE (formalin-fixed paraffin-embedded) tumor tissue, without the need for a reference sample.