TY - JOUR
T1 - Recommendations for Cell-Free DNA Assay Validations
T2 - A Joint Consensus Recommendation of the Association for Molecular Pathology and College of American Pathologists
AU - Lockwood, Christina M.
AU - Borsu, Laetitia
AU - Cankovic, Milena
AU - Earle, Jonathan S.L.
AU - Gocke, Christopher D.
AU - Hameed, Meera
AU - Jordan, Danielle
AU - Lopategui, Jean R.
AU - Pullambhatla, Mrudula
AU - Reuther, Jacquelyn
AU - Rumilla, Kandelaria M.
AU - Tafe, Laura J.
AU - Temple-Smolkin, Robyn L.
AU - Terraf, Panieh
AU - Tsimberidou, Apostolia M.
N1 - Publisher Copyright:
© 2023 Association for Molecular Pathology and American Society for Investigative Pathology
PY - 2023/12
Y1 - 2023/12
N2 - 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. The Association for Molecular Pathology Clinical Practice Committee's Liquid Biopsy Working Group (LBxWG), including organizational representation from the American Society of Clinical Oncology and the College of American Pathologists, has undertaken a full-text data extraction of 1228 ctDNA publications that describe assays performed in patients with lymphoma and solid tumor malignancies. With an emphasis on clinical assay validation, the LBxWG has developed a set of 13 best practice consensus recommendations for validating, reporting, and publishing clinical ctDNA assays. Recommendations include reporting key pre-analytical considerations and assay performance metrics; this analysis demonstrates these elements are inconsistently included in publications. The LBxWG recommendations are intended to assist clinical laboratories with validating and reporting ctDNA assays and to ensure high-quality data are included in publications. It is expected that these recommendations will need to be updated as the body of literature continues to mature.
AB - 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. The Association for Molecular Pathology Clinical Practice Committee's Liquid Biopsy Working Group (LBxWG), including organizational representation from the American Society of Clinical Oncology and the College of American Pathologists, has undertaken a full-text data extraction of 1228 ctDNA publications that describe assays performed in patients with lymphoma and solid tumor malignancies. With an emphasis on clinical assay validation, the LBxWG has developed a set of 13 best practice consensus recommendations for validating, reporting, and publishing clinical ctDNA assays. Recommendations include reporting key pre-analytical considerations and assay performance metrics; this analysis demonstrates these elements are inconsistently included in publications. The LBxWG recommendations are intended to assist clinical laboratories with validating and reporting ctDNA assays and to ensure high-quality data are included in publications. It is expected that these recommendations will need to be updated as the body of literature continues to mature.
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U2 - 10.1016/j.jmoldx.2023.09.004
DO - 10.1016/j.jmoldx.2023.09.004
M3 - Review article
C2 - 37806433
AN - SCOPUS:85177979640
SN - 1525-1578
VL - 25
SP - 876
EP - 897
JO - Journal of Molecular Diagnostics
JF - Journal of Molecular Diagnostics
IS - 12
ER -