The Association for Molecular Pathology (AMP), in collaboration with the American Society of Clinical Oncology (ASCO) and the College of American Pathologists (CAP), has released a set of 13 best practice recommendations for the validation and reporting of clinical circulating tumor DNA (ctDNA) or liquid biopsy assays. This manuscript, titled “Recommendations for Cell-free DNA Assay Validations,” was published ahead of its appearance in The Journal of Molecular Diagnostics.
The advancements in molecular diagnostics over the past decade have enabled the precise detection and measurement of low abundance ctDNA in blood and body fluids. However, the development, validation, and reporting of these liquid biopsy assays can vary. This new report aims to standardize, improve transparency, and enhance the quality among laboratories. The recommendations were formulated based on a review of over 1,200 publications detailing ctDNA assay performance in patients with lymphoma and solid tumor malignancies, combined with expert professional experience.
Christina Lockwood, PhD, Chair of the AMP Liquid Biopsy Working Group, emphasized the significance of these recommendations in promoting standardization and quality improvement. Susan Hsiao, MD, PhD, 2023 AMP Clinical Practice Committee Chair, highlighted the commitment of AMP to continually reassess and modify their recommendations as technologies evolve and more data becomes available.