Abstract

Taking a Liquid Biopsy from Lab to Clinic: What It Takes to Get Ready for Prime Time

Daniel Hayes, Clinical Director, University of Michigan

A tumor biomarker liquid biopsy test, is not just an assay for circulating proteins, tumor cells, or cell free DNA. Rather, it is a precisely developed assay that has high analytical validity and clinical utility for a specific use context. Clinical utility requires consideration of several factors and the generation of high levels of evidence that use of the assay, compared to not having the results at all, improves patient outcomes – preferably either quality or quantity of life. These issues will be discussed in the presentation.