The Association for Molecular Pathology (AMP) has published its best-practice recommendations for validating, reporting, and publishing clinical circulating tumor DNA (ctDNA) assays.
The recommendations, published online in the Journal of Molecular Diagnostics, were developed by AMP’s Clinical Practice Committee's Liquid Biopsy Working Group, with representation from the American Society of Clinical Oncology and the College of American Pathologists. The working group’s recommendations were based on a review of 1,228 publications describing ctDNA assay performance in patients with lymphoma and solid tumor malignancies in addition to subject-matter expert input. The recommendations include reporting key pre-analytical considerations and assay performance metrics.
The group notes that the study it performed was limited to ctDNA during its initial discussions with the note that “the literature regarding ctDNA was the most developed at that time and was amenable to an evidence-based literature review.”
“One of the most important technological advances in molecular diagnostics over the past decade has been the ability to accurately detect and measure low abundance ctDNA in blood and body fluids,” Christina Lockwood, PhD, chair of the AMP Liquid Biopsy Working Group and professor and division head of Laboratory Genetics at the University of Washington School of Medicine said in a statement on AMP’s site.
“As with any emerging technology or methodology, the way these liquid biopsy assays are developed, validated, and reported can vary. This new report provides a set of evidence-based recommendations that can help promote standardization, transparency, and quality improvement among laboratories,” Lockwood stated.
