Biocartis Group has signed a collaboration agreement with Bristol-Myers Squibb to register and use the Idylla 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 tumour 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 tumours, including approximately 15% of colorectal (CRC) tumours.
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 Idylla MSI test, which received CE-IVD marking on 28 February 2019, provides information on the MSI status of CRC tumours within approximately 150 minutes from just one slice of FFPE tumour tissue, without the need of a reference sample.
The collaboration agreement allows for joint developments and registrations of the Idylla 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 US of the Idylla 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 leaders in the area of immuno-oncology therapies. It is our belief that because of the advantages of our Idylla 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 personalised medicine an everyday reality."