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Updated: Dec 17, 2025

A Standardized Liquid Biopsy Preanalytical Protocol for Downstream Circulating-Free DNA Applications
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Developing Quality Programs for Cell-Free DNA (cfDNA) Extraction from Peripheral Blood.

Aliaksandra Samoila1, Jose Sosa1, Jessica Padilla1

  • 1Department of Laboratory Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.

The Journal of Applied Laboratory Medicine
|July 1, 2020
PubMed
Summary

Developing robust quality control for cell-free DNA (cfDNA) analysis ensures reliable cancer detection. This program standardizes cfDNA isolation, improving the accuracy of minimally invasive liquid biopsy testing.

Keywords:
cfDNApreanalytical qualityquality assurancequality control

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Area of Science:

  • Biochemistry
  • Molecular Biology
  • Oncology

Background:

  • Cell-free DNA (cfDNA) analysis in peripheral blood offers a minimally invasive approach for cancer diagnosis and monitoring.
  • Test reliability hinges on accurate molecular analysis of tumor-associated genomic variants and sufficient cfDNA quantity/quality.
  • Current limitations include a lack of standardized guidelines for cfDNA isolation and quality control reagents.

Purpose of the Study:

  • To describe and illustrate quality control (QC) and quality assurance (QA) processes for cfDNA analysis.
  • To present the development of in-house quality control materials for cfDNA isolation.
  • To ensure the reliability of the preanalytical phase of cfDNA testing.

Main Methods:

  • Implementation of a comprehensive quality program for high-volume automated cfDNA extraction.
  • Development of processes to monitor specimen collection adequacy and stability.
  • Establishment of procedures to assess cfDNA extraction efficiency and quality.

Main Results:

  • A robust quality program was successfully developed and implemented.
  • Processes effectively monitor critical preanalytical steps in cfDNA isolation.
  • In-house QC materials support consistent and reliable cfDNA analysis.

Conclusions:

  • Standardized QC and QA are crucial for reliable cfDNA analysis.
  • The developed program enhances the preanalytical phase of liquid biopsy.
  • This approach supports accurate cancer diagnosis and monitoring using cfDNA.