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It highlights technical and clinical challenges, focusing on the Liquid Biopsy Consortium’s work addressing biomarker development, validation, and recommendations for advancing assay 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monitoring  \nSyeda Maheen Batool,1,16 Anudeep Yekula,1,16 Prerna Khanna,1 Tiffaney Hsia,1 Austin S. Gamblin,1 Emil Ekanayake,1 Ana K. Escobedo,1 Dong Gil You,1 Cesar M. Castro,1 Hyungsoon Im,1 Tugba Kilic,1 Michelle Andrea Garlin,1 Johan Skog,2 Daniela M. Dinulescu,3 Jonathan Dudley,4 Nishant Agrawal,5 Jordan Cheng,6 Fereidoun Abtin,6 Denise R. Aberle,6 David Chia,6 David Elashoff,6 Tristan Grognan,6 Kostyantyn Krysan,6 Scott S. Oh,6 Charles Strom,6 Michael Tu,15 Fang Wei,6 Rena R. Xian,4 Steven J. Skates,1 David Y. Zhang,7 Thi Trinh,8 Mark Watson,9 Rebecca Aft,9 Siddarth Rawal,9,10 Ashutosh Agarwal,11 Susan B. Kesmodel,11 Changhuei Yang,12 Cheng Shen,12 Fred H. Hochberg,13 David T.W. Wong,6 Abhijit A. Patel,8 Nickolas Papadopoulos,4 Chetan Bettegowda,4 Richard J. Cote,9,10 Sudhir Srivastava,14 Hakho Lee,1 Bob S. Carter,1,17 and Leonora Balaj1,17,*  \n1Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA  \n2Exosome Diagnostics Inc. , Waltham, MA, USA  \n3Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA  \n4Johns Hopkins University School of Medicine, Baltimore, MD, USA  \n5University of Chicago School of Medicine, Chicago, IL, USA  \n6University of California Los Angeles, Los Angeles, CA, USA  \n7Rice University, Houston, TX, USA  \n8Yale University School of Medicine, New Haven, CT, USA  \n9Washington University School of Medicine, St. Louis, MO, USA  \n10Circulogix Inc. , St. Louis, MO, USA  \n11University of Miami, Miami, FL, USA  \n12California Institute of Technology, Pasadena, CA, USA  \n13Scintillon Institute, La Jolla, CA, USA  \n14Cancer Biomarkers Research Group, Division of Cancer Prevention, National Cancer Institute, Bethesda, MD, USA  \n15Liquid Diagnostics LLC. , Los Angeles, CA, USA  \n16These authors contributed equally  \n17Senior authors  \n*Correspondence: [balaj.leonora@mgh.harvard.edu](balaj.leonora@mgh.harvard.edu)[ ](balaj.leonora@mgh.harvard.edu)[https://doi.org/10.1016/j.xcrm.2023.101](https://doi.org/10.1016/j.xcrm.2023.101)198  \nSUMMARY  \nThe emerging field of liquid biopsy stands at the forefront of novel diagnostic strategies for cancer and other diseases. Liquid biopsy allows minimally invasive molecular characterization of cancers for diagnosis, patient stratification to therapy, and longitudinal monitoring. Liquid biopsy strategies include detection and monitoring of circulating tumor cells, cell-free DNA, and extracellular vesicles. In this review, we address the current understanding and the role of existing liquid-biopsy-based modalities in cancer diagnostics and monitoring. We specifically focus on the technical and clinical challenges associated with liquid biopsy and biomarker development being addressed by the Liquid Biopsy Consortium, established through the National Cancer Institute. The Liquid Biopsy Consortium has developed new methods/assays and validated existing methods/technologies to capture and characterize tumor-derived circulating cargo, as well as addressed existing challenges and provided recommendations for advancing biomarker assays.  \nINTRODUCTION  \nCancer remains the second leading cause of death in the United States, with more than 1.8 million new cancer diagnoses and more than 0 .6 million cancer deaths each year.1 With such an overwhelming burden on society, early cancer diagnosis is imperative to increasing survival rates and reducing care costs. For example, to date, as a result of population screening with invasive modalities such as colonoscopy, mammogram, and  \npap smear, overall cancer mortality has decreased by more than 25% from 1990 to 2015 in the United States, with a significant decline in mortality rates for colon cancer and breast cancer.2  \nAlthough imaging (breast) and some blood-based screenings (colorectal, prostate cancer) are available for certain cancers, these modalities do not provide insights into the genetic p","cbCaiaifR3KzCo05","https://ap.wps.com/l/cbCaiaifR3KzCo05","pdf",2679875,12,"English","# Summary\n# Introduction\n## Clinical need for early diagnosis\n## Limits of imaging and tissue biopsy\n# Liquid biopsy approaches and evidence gaps\n# Role of large multi-institution collaborations\n# Liquid Biopsy Consortium: methods, validation, and recommendations","[{\"question\":\"What is liquid biopsy used for in cancer care?\",\"answer\":\"Liquid biopsy supports minimally invasive diagnosis through molecular characterization, helps stratify patients for therapy, and enables longitudinal monitoring of cancer.\"},{\"question\":\"Which biological components are commonly analyzed in liquid biopsy?\",\"answer\":\"Common targets include circulating tumor cells, circulating nucleic acids such as cell-free DNA and RNA (including miRNA and lncRNAs), extracellular vesicles, tumor-educated platelets, proteins, and metabolites.\"},{\"question\":\"Why is multi-institutional collaboration important for liquid biopsy assays?\",\"answer\":\"Large-scale collaboration is needed to develop reliable, reproducible, and clinically useful assays, addressing reproducibility and validation limitations seen in many single-center studies.\"}]","The Liquid Biopsy Consortium - Challenges and opportunities for early cancer detection and monitoring | PDF",1790224263]