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Event
Conference Room 3: Multicancer early detection techniques & Companion diagnostics for precision oncology
Title: Facilitating companion diagnostics studies to reach effective personalized medicine
Summary:
High level of trial failure in oncology remains for a large fraction imputable to poor patients’ stratification. Moving away from discrete phase 1, 2 and 3 for faster, agile trial designs including innovative early biomarker discovery correlating with higher treatment efficacy are strategies improving significantly trials success rate.
Such innovative trial design typically includes for stratification in early phase I, retrospective biomarker exploratory analysis allowing for wider research spectrum that can be verified in later trial phases. Typically, such exploratory analyses are performed on non-invasive liquid biopsies with sensitive NGS cell-free DNA assays for biomarker discovery from genetic variant profiles.
Alternatively, a trial may be built on a biomarker-informed strategy with a fit for purpose assay development based on intended use and regulatory requirements. Such option involves high level of validation for prospective testing, requires early stage partnership between drug pharma and diagnostic device manufacturers to align on respective development timelines.
Synergy between assay development partners able to provide kitted IVD platforms with global central laboratories producing combinable data and specialized trial management teams dedicated to align efforts with Pharma partners are key for facilitating companion diagnostics studies in the current competitive market landscape.
Speaker:
Alexandre Fort, PhD
Labcorp Lead Scientist – Genomics