Genetic Test Evaluation

understanding how genetic tests impact patient management

FoundationACT (Foundation Medicine Inc.)

July 23, 2018

Cancer is the second most common cause of death in the United States. In 2018, it was estimated that cancer would affect 1,735,350 Americans, causing death in approximately 609,640 cases. The age-adjusted death rate per year from cancer in the United States was 163.5 per 100,000 individuals from 2011 to 2015. Of men and women born in the United States today, approximately 38% will be diagnosed with cancer at some stage in their lives. Genetic and genomic testing is of great interest in the evaluation of cancer, as cancer is essentially a disease in which dysfunctional genetic alterations lead to abnormal cell growth and division. The number of genomic alterations that are predictive biomarkers for approved targeted therapies or used as inclusion criteria for clinical trials has increased exponentially with the development of next-generation sequencing (NGS). The ability to evaluate hundreds of cancer-related genes has transitioned from the research setting into an important tool for routine clinical management. However, there can be limitations in using tumor specimens; use of cell-free circulating tumor DNA (ctDNA) released from tumor cells aims to circumvent these limitations by using blood samples for molecular tumor profiling. This synopsis specifically focuses on 1 of these assays, FoundationACT, offered by Foundation Medicine Inc., which analyzes > 60 genes in solid tumors by using ctDNA from a blood sample. Identified genomic alterations can potentially be used to guide treatment. This report does not evaluate the evidence for liquid biopsy assays in general or specific gene associations and targeted therapies.