CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
September 2019—Caris Life Sciences has entered into a strategic collaboration with Debiopharm for the development of a companion diagnostic test using Caris’ whole transcriptome sequencing assay for mRNA analysis called MI Transcriptome. The assay, which was granted breakthrough device designation by the FDA in May, detects rare fibroblast growth factor receptor (FGFR1, FGFR2, and FGFR3) fusion events.
Under the agreement, MI Transcriptome will be used to identify eligible patients for Debiopharm’s FUZE phase two pivotal trial of Debio 1347, a selective FGFR inhibitor that Debiopharm is evaluating for the treatment of patients with non–central nervous system solid tumors that have a specific FGFR gene fusion. Debio 1347 received fast track designation from the FDA earlier this year.