Establishing a Common Lexicon for Circulating Tumor DNA Analysis and Molecular Residual Disease: Insights From the BLOODPAC Consortium

ABSTRACT The use of a liquid biopsy to assess molecular residual disease (MRD) of solid tumors holds significant promise for improving outcomes for patients with cancer. Liquid biopsies are a minimally invasive approach for the identification of circulating tumor biomarkers through a simple blood sa...

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Main Authors: Andrew G. Hadd, Angela Silvestro, Brittany Avin McKelvey, Jonathan Baden, Christina Bormann Chung, Ben Brown, Fernando Cruz‐Guilloty, James Godsey, Gregory Jones, Cheng‐Ho Jimmy Lin, Dorys Lopez Ramos, Daniel Norton, Melanie R. Palomares, Carol Pena, Thereasa Rich, Angel Rodriguez, Mark Stewart, Diana Merino Vega, Lauren C. Leiman
Format: Article
Language:English
Published: Wiley 2025-03-01
Series:Clinical and Translational Science
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Online Access:https://doi.org/10.1111/cts.70185
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author Andrew G. Hadd
Angela Silvestro
Brittany Avin McKelvey
Jonathan Baden
Christina Bormann Chung
Ben Brown
Fernando Cruz‐Guilloty
James Godsey
Gregory Jones
Cheng‐Ho Jimmy Lin
Dorys Lopez Ramos
Daniel Norton
Melanie R. Palomares
Carol Pena
Thereasa Rich
Angel Rodriguez
Mark Stewart
Diana Merino Vega
Lauren C. Leiman
author_facet Andrew G. Hadd
Angela Silvestro
Brittany Avin McKelvey
Jonathan Baden
Christina Bormann Chung
Ben Brown
Fernando Cruz‐Guilloty
James Godsey
Gregory Jones
Cheng‐Ho Jimmy Lin
Dorys Lopez Ramos
Daniel Norton
Melanie R. Palomares
Carol Pena
Thereasa Rich
Angel Rodriguez
Mark Stewart
Diana Merino Vega
Lauren C. Leiman
author_sort Andrew G. Hadd
collection DOAJ
description ABSTRACT The use of a liquid biopsy to assess molecular residual disease (MRD) of solid tumors holds significant promise for improving outcomes for patients with cancer. Liquid biopsies are a minimally invasive approach for the identification of circulating tumor biomarkers through a simple blood sample. Assays capable of detecting MRD through analysis of circulating tumor DNA (ctDNA) are rapidly evolving for clinical study applications and therapeutic interventions. To address these opportunities, BLOODPAC—a multi‐disciplinary consortium representing stakeholders from public, industry, academia, and regulatory agencies—formulated a lexicon that provides a shared framework and clear definitions using liquid biopsies for solid tumor MRD with an emphasis on ctDNA detection. The terms in the lexicon are categorized under general MRD, ctDNA testing methodologies, reporting results, and acquisition timepoints, including examples of current and potential clinical use cases for MRD tests. The overall goal is to provide a unified language and approaches to solid tumor MRD to advance applications of these technologies, allow data aggregation to strengthen future evidence, and facilitate regulatory approvals, leading to the use of liquid biopsy as an early endpoint in clinical trials. We believe that a common set of terminology and methods for solid tumor MRD can improve understanding and appropriate use of testing, accelerate clinical development, and improve outcomes for cancer patients.
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spelling doaj-art-b30347af16814c6ea25edaa71db542ac2025-08-20T03:42:04ZengWileyClinical and Translational Science1752-80541752-80622025-03-01183n/an/a10.1111/cts.70185Establishing a Common Lexicon for Circulating Tumor DNA Analysis and Molecular Residual Disease: Insights From the BLOODPAC ConsortiumAndrew G. Hadd0Angela Silvestro1Brittany Avin McKelvey2Jonathan Baden3Christina Bormann Chung4Ben Brown5Fernando Cruz‐Guilloty6James Godsey7Gregory Jones8Cheng‐Ho Jimmy Lin9Dorys Lopez Ramos10Daniel Norton11Melanie R. Palomares12Carol Pena13Thereasa Rich14Angel Rodriguez15Mark Stewart16Diana Merino Vega17Lauren C. Leiman18Natera Austin Texas USAGSK Waltham Massachusetts USAFriends of Cancer Research Washington DC USABristol Myers Squibb Lawrence Township New Jersey USAGRAIL, Inc. Menlo Park California USAAdela Bio Foster City California USAJohnson & Johnson New Brunswick New Jersey USAQuest Diagnostics Secaucus New Jersey USANeoGenomics Fort Myers Florida USAFreenome San Francisco California USABLOODPAC Chicago Illinois USAPersonalis Fremont California USAExact Sciences Madison Wisconsin USAMerck & co., Inc. Rahway New Jersey USAGuardant Health Palo Alto California USANatera Austin Texas USAFriends of Cancer Research Washington DC USAAstraZeneca Gaithersburg Maryland USABLOODPAC Chicago Illinois USAABSTRACT The use of a liquid biopsy to assess molecular residual disease (MRD) of solid tumors holds significant promise for improving outcomes for patients with cancer. Liquid biopsies are a minimally invasive approach for the identification of circulating tumor biomarkers through a simple blood sample. Assays capable of detecting MRD through analysis of circulating tumor DNA (ctDNA) are rapidly evolving for clinical study applications and therapeutic interventions. To address these opportunities, BLOODPAC—a multi‐disciplinary consortium representing stakeholders from public, industry, academia, and regulatory agencies—formulated a lexicon that provides a shared framework and clear definitions using liquid biopsies for solid tumor MRD with an emphasis on ctDNA detection. The terms in the lexicon are categorized under general MRD, ctDNA testing methodologies, reporting results, and acquisition timepoints, including examples of current and potential clinical use cases for MRD tests. The overall goal is to provide a unified language and approaches to solid tumor MRD to advance applications of these technologies, allow data aggregation to strengthen future evidence, and facilitate regulatory approvals, leading to the use of liquid biopsy as an early endpoint in clinical trials. We believe that a common set of terminology and methods for solid tumor MRD can improve understanding and appropriate use of testing, accelerate clinical development, and improve outcomes for cancer patients.https://doi.org/10.1111/cts.70185ctDNAliquid biopsyMRD
spellingShingle Andrew G. Hadd
Angela Silvestro
Brittany Avin McKelvey
Jonathan Baden
Christina Bormann Chung
Ben Brown
Fernando Cruz‐Guilloty
James Godsey
Gregory Jones
Cheng‐Ho Jimmy Lin
Dorys Lopez Ramos
Daniel Norton
Melanie R. Palomares
Carol Pena
Thereasa Rich
Angel Rodriguez
Mark Stewart
Diana Merino Vega
Lauren C. Leiman
Establishing a Common Lexicon for Circulating Tumor DNA Analysis and Molecular Residual Disease: Insights From the BLOODPAC Consortium
Clinical and Translational Science
ctDNA
liquid biopsy
MRD
title Establishing a Common Lexicon for Circulating Tumor DNA Analysis and Molecular Residual Disease: Insights From the BLOODPAC Consortium
title_full Establishing a Common Lexicon for Circulating Tumor DNA Analysis and Molecular Residual Disease: Insights From the BLOODPAC Consortium
title_fullStr Establishing a Common Lexicon for Circulating Tumor DNA Analysis and Molecular Residual Disease: Insights From the BLOODPAC Consortium
title_full_unstemmed Establishing a Common Lexicon for Circulating Tumor DNA Analysis and Molecular Residual Disease: Insights From the BLOODPAC Consortium
title_short Establishing a Common Lexicon for Circulating Tumor DNA Analysis and Molecular Residual Disease: Insights From the BLOODPAC Consortium
title_sort establishing a common lexicon for circulating tumor dna analysis and molecular residual disease insights from the bloodpac consortium
topic ctDNA
liquid biopsy
MRD
url https://doi.org/10.1111/cts.70185
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