The Association for Molecular Pathology (AMP) published a set of 13 best practice recommendations for validating and reporting clinical circulating tumor DNA (ctDNA) or liquid biopsy assays and their related scientific publications.
The manuscript, “Recommendations for Cell-free DNA Assay Validations: A Joint Consensus Recommendation of the Association for Molecular Pathology and College of American Pathologists (CAP),” was released online ahead of publication in The Journal of Molecular Diagnostics.
The AMP Clinical Practice Committee’s Liquid Biopsy Working Group, including organizational representation from the American Society of Clinical Oncology (ASCO) and CAP, developed a set of recommendations for validating, reporting, and publishing clinical ctDNA assays. The recommendations are based on a review of more than 1,200 publications that describe ctDNA assay performance in patients with lymphoma and solid tumor malignancies and subject matter expert professional experience. The recommendations include reporting key pre-analytical considerations and assay performance metrics.
