A liquid biopsy is a simple and non-invasive alternative to surgical biopsies. It has the potential to identify genetic abnormalities that may guide treatment selection as well as detect disease progression or treatment resistance long before it would trigger clinical symptoms or appear on imaging scans. Liquid biopsies consist of isolating tumor-derived entities like circulating tumor cells (CTC), circulating tumor DNA (ctDNA), tumor extracellular vesicles (EV), etc., present in the body fluids of patients and using them to derive genomic and proteomic data. This reveals greater details about tumor characteristics such as tumor progression, tumor staging, heterogeneity, gene mutations and clonal evolution.
Technological innovation in liquid biopsy platforms and testing methodologies led to a rapid transformation of precision medicine in cancer care. As a result, several liquid biopsy tests have been approved by the US Food and Drug Administration (FDA). In 2013, the FDA approved CellSearchCTC enumeration platform, which detects CTC in blood. In 2016, the FDA approved the first ctDNA blood test to detect epidermal growth factor receptor (EGFR) gene mutations in patients with non-small cell lung cancer (NSCLC). In 2020, the FDA approved two additional comprehensive genomic profiling liquid biopsy tests, Guardant360 CDx and FoundationOne Liquid CDx, both of which utilize next-generation sequencing (NGS) technology to detect tumor genomic alterations in cell-free ctDNA in blood.
Although liquid biopsy is expected to complement and not replace tissue biopsy in the foreseeable future, its non-invasive nature promises to open new eras in clinical oncology. It has the potential to change the prognostic and predictive landscape for cancer genotyping and impact patient management. However, several technical and biological limitations still hamper the implementation of liquid biopsy in clinical practice.
Join the featured speakers from Medpace, as they provide an overview of the current methodologies involved in liquid biopsies and their application for detection of genetic mutations. Register to learn how liquid biopsies may help with treatment selection and monitoring of cancer treatment outcomes.
Along with our experienced CRO and strategic anatomical pathology lab partners, Medpace’s Central Lab has broad experience in managing oncology (e.g. Hematological, Immuno-Therapy, and Solid Tumors) clinical trials. Medpace has been proactive in implementing testing capabilities that match the spectrum of oncology clinical development approaches needed to support pharmaceutical industry partners. Learn more about our Central Lab capabilities.