Biocartis Group NV

Biocartis and Bristol-Myers Squibb Sign Collaboration Agreement for MSI Testing with Immuno-Oncology Therapies

PRESS RELEASE                                                            12 March 2019, 07:00 CET

Biocartis and Bristol-Myers Squibb Sign Collaboration Agreement for MSI Testing with Immuno-Oncology Therapies

Mechelen, Belgium, 12 March 2019 - Biocartis Group NV (the 'Company' or 'Biocartis'), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announced the signing of a collaboration agreement with Bristol-Myers Squibb Company (NYSE: BMY), a global biopharmaceutical company, aimed at the potential registration as a companion diagnostic and use of the Idylla^TM 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^[1], including approximately 15% of colorectal (CRC) tumors^[2]. In addition to applications for CRC, MSI is believed to be an independent factor that may predict a patient's response to certain immunotherapies^[3].

Bristol-Myers Squibb's Opdivo (nivolumab) plus low-dose Yervoy^[4] (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^[5].

The fully automated Idylla^TM MSI test, that received CE-IVD marking on February 28, 2019, provides information on the MSI status^[6],[7],[8] of CRC tumors within approximately 150 minutes from just one slice of FFPE^[9] tumor tissue, without the need of a reference sample.

The collaboration agreement allows for joint developments and registrations of the Idylla^TM 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 Idylla^TM MSI test as a companion diagnostic test in mCRC.