The cornerstone of integrating circulating tumor DNA into cancer management

Ziyang Li; Lang Yi; Peng Gao; Rui Zhang; Jinming Li

doi:10.1016/j.bbcan.2018.11.002

The cornerstone of integrating circulating tumor DNA into cancer management

Biochim Biophys Acta Rev Cancer. 2019 Jan;1871(1):1-11. doi: 10.1016/j.bbcan.2018.11.002. Epub 2018 Nov 9.

Authors

Ziyang Li¹, Lang Yi², Peng Gao¹, Rui Zhang³, Jinming Li⁴

Affiliations

¹ National Center for Clinical Laboratories, Beijing Hospital, National Center of Gerontology, Beijing, People's Republic of China; Graduate School, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing 100730, People's Republic of China.
² Department of Clinical Laboratory, Xiangya Hospital, Central South University, Changsha, Hunan, People's Republic of China.
³ National Center for Clinical Laboratories, Beijing Hospital, National Center of Gerontology, Beijing, People's Republic of China. Electronic address: ruizhang@nccl.org.cn.
⁴ National Center for Clinical Laboratories, Beijing Hospital, National Center of Gerontology, Beijing, People's Republic of China; Graduate School, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing 100730, People's Republic of China. Electronic address: jmli@nccl.org.cn.

PMID: 30419316
DOI: 10.1016/j.bbcan.2018.11.002

Abstract

Recent circulating tumor DNA (ctDNA) research has demonstrated its potential as a non-invasive biomarker for cancer. However, the deployment of ctDNA assays in routine clinical practice remains challenging owing to variability in analytical approaches and the assessment of clinical significance. A well-developed, analytically valid ctDNA assay is a prerequisite for integrating ctDNA into cancer management, and an appropriate analytical technology is crucial for the development of a ctDNA assay. Other determinants including pre-analytical procedures, test validation, internal quality control (IQC), and continual proficiency testing (PT) are also important for the accuracy of ctDNA assays. In the present review, we will focus on the most widely used ctDNA detection technologies and the key quality management measures used to assure the accuracy of ctDNA assays. The aim of this review is to provide useful information for technology selection during ctDNA assay development and assure a reliable test result in clinical practice.

Keywords: Analytical validity; Cancer; Circulating tumor DNA assays; Quality management; Technology.

Publication types

Research Support, Non-U.S. Gov't
Review

MeSH terms

Biomarkers, Tumor / analysis*
Circulating Tumor DNA / analysis*
Early Detection of Cancer / methods
High-Throughput Nucleotide Sequencing / methods*
Humans
Neoplasms / blood*
Polymerase Chain Reaction / methods*

Substances

Biomarkers, Tumor
Circulating Tumor DNA