Abstract

Aspirations For and the Current Status of Blood-based Cancer Diagnostics

Walter Koch, Vice President, Roche Molecular Systems

Dozens of published research studies have reported that quantitative analysis of somatic mutations in blood is associated with dynamic responses of tumors to therapy, development of drug resistance during therapy and relapse after treatment, as well as genomic evolution of primary tumors and metastases.  To date, only one “liquid biopsy” test has gained FDA approval; the cobas® EGFR Mutation Test v2 is used to genotype NSCLC for dozens of EGFR activating and resistance mutations used for selection of tyrosine kinase inhibitors Erlotinib or Osimertinib.  Beyond genotyping tumors for therapy selection or clinical trial enrollment, there is an unmet medical need for better noninvasive biomarkers to monitor solid tumor therapy response, recurrence, and residual disease after surgical removal of early stage tumors.  This talk will explore the clinical development needed for liquid biopsy tests to be broadly included in cancer diagnosis and treatment guidelines, and to be used in routine clinical care with reimbursement.