Clinical Practice Guideline for Blood-based Circulating Tumor DNA Assays

Ann Lab Med. 2024 May 1;44(3):195-209. doi: 10.3343/alm.2023.0389. Epub 2024 Jan 15.

Abstract

Circulating tumor DNA (ctDNA) has emerged as a promising tool for various clinical applications, including early diagnosis, therapeutic target identification, treatment response monitoring, prognosis evaluation, and minimal residual disease detection. Consequently, ctDNA assays have been incorporated into clinical practice. In this review, we offer an in-depth exploration of the clinical implementation of ctDNA assays. Notably, we examined existing evidence related to pre-analytical procedures, analytical components in current technologies, and result interpretation and reporting processes. The primary objective of this guidelines is to provide recommendations for the clinical utilization of ctDNA assays.

Keywords: Cell-free nucleic acid; Circulating tumor DNA; Guideline; High-throughput nucleotide sequencing.

Publication types

  • Review
  • Guideline

MeSH terms

  • Biomarkers, Tumor / genetics
  • Circulating Tumor DNA* / genetics
  • High-Throughput Nucleotide Sequencing
  • Humans
  • Mutation
  • Neoplasm, Residual / genetics
  • Prognosis

Substances

  • Circulating Tumor DNA
  • Biomarkers, Tumor

Grants and funding

RESEARCH FUNDING None declared.