Recommendations for Cell-free DNA Assay Validations: A Joint Consensus Recommendation of the Association for Molecular Pathology and College of American Pathologists

Diagnosing, selecting therapy for, and monitoring cancer in patients using a minimally invasive blood test represents a significant advance in precision medicine. Wide variability exists in how circulating tumor DNA (ctDNA) assays are developed, validated, and reported in the literature, which hinders clinical adoption and may negatively impact patient care. Standardization is needed for factors affecting ctDNA assay performance and reporting, including pre-analytical variables, analytical considerations, and elements of laboratory assay reporting.

Source: Journal of Molecular Diagnostics - October 6, 2023 Category: Pathology Authors: Christina M. Lockwood, Laetitia Borsu, Milena Cankovic, Jonathan S.L. Earle, Christopher D. Gocke, Meera Hameed, Danielle Jordan, Jean R. Lopategui, Mrudula Pullambhatla, Jacquelyn Reuther, Kandelaria M. Rumilla, Laura J. Tafe, Robyn L. Temple-Smolkin, Pa Tags: Special Article Source Type: research