Abstract

Colvera™, A ctDNA Liquid Biopsy Assay for Colorectal Cancer. Our Journey from Discovery to the Clinic

Jason Ross, Sr Research Scientist And Team Leader, CSIRO

We have developed Colvera™, a ctDNA liquid biopsy assay to diagnose and monitor colorectal cancer. The assay is based upon detecting circulating tumour DNA from two genes methylated in colorectal cancer, but unmethylated in non-neoplastic tissue or blood. The test has good performance; in a prospective study of 2105 patients, Colvera™ had sensitivity of 66% and specificity of 94% in diagnosing cancer and is also similarly effective in detecting cancer recurrance. It has over twice the predictive performance of Carcinoembryonic antigen (CEA), the only guideline-recommended blood test for monitoring cases for recurrence. Presently, we are working on a new clinical assay which removes the bisulfite-treatment step and offers similar performance. I will discuss the journey we and our collaborators undertook: from biomarker discovery and validation, to assay design and then to clinical trials and the launch of a commercial lab test.