From laboratory to clinic: Translation of extracellular vesicle based cancer biomarkers

Anudeep Yekula; Koushik Muralidharan; Keiko M Kang; Lan Wang; Leonora Balaj; Bob S Carter

doi:10.1016/j.ymeth.2020.02.003

From laboratory to clinic: Translation of extracellular vesicle based cancer biomarkers

Methods. 2020 May 1:177:58-66. doi: 10.1016/j.ymeth.2020.02.003. Epub 2020 Feb 12.

Authors

Anudeep Yekula¹, Koushik Muralidharan², Keiko M Kang³, Lan Wang⁴, Leonora Balaj⁵, Bob S Carter⁶

Affiliations

¹ Department of Neurosurgery, Massachusetts General Hospital and Harvard Medical School and Harvard Medical School, Boston, MA, United States. Electronic address: ayekula@mgh.harvard.edu.
² Department of Neurosurgery, Massachusetts General Hospital and Harvard Medical School and Harvard Medical School, Boston, MA, United States. Electronic address: KMURALIDHARAN@mgh.harvard.edu.
³ Department of Neurosurgery, Massachusetts General Hospital and Harvard Medical School and Harvard Medical School, Boston, MA, United States; School of Medicine, University of California, San Diego, La Jolla, CA, United States. Electronic address: KMKANG@mgh.harvard.edu.
⁴ Department of Neurosurgery, Massachusetts General Hospital and Harvard Medical School and Harvard Medical School, Boston, MA, United States. Electronic address: LWANG60@mgh.harvard.edu.
⁵ Department of Neurosurgery, Massachusetts General Hospital and Harvard Medical School and Harvard Medical School, Boston, MA, United States. Electronic address: Balaj.Leonora@mgh.harvard.edu.
⁶ Department of Neurosurgery, Massachusetts General Hospital and Harvard Medical School and Harvard Medical School, Boston, MA, United States. Electronic address: BCARTER@mgh.harvard.edu.

Abstract

The past decade has witnessed a rapid growth in the field of extracellular vesicle (EV) based biomarkers for the diagnosis and monitoring of cancer. Several studies have reported novel EV based biomarkers, but the technical and clinical validation phase has been hampered by general challenges common to biomedical research field as well as specific challenges inherent to the nanoparticle field. This has led to more common failures than success stories in the biomarker discovery pipeline. As a result, more attention must be focused on the process of biomarker discovery, verification, and validation to allow for translation and application of novel EV based research to patient care. Herein, we briefly discuss the hurdles and potential solutions in EV biomarker discovery and verification and validation, and clinical translation.

Keywords: Biomarker discovery; Biomarker validation; Biomarkers; CLIA; Clinical translation; Extracellular vesicles.

Publication types

Research Support, N.I.H., Extramural
Review

MeSH terms

Biomarkers, Tumor / blood*
Biomarkers, Tumor / cerebrospinal fluid
Biomarkers, Tumor / urine
Extracellular Vesicles / chemistry*
Extracellular Vesicles / metabolism
Humans
Nasal Cavity / chemistry
Neoplasms / blood
Neoplasms / cerebrospinal fluid
Neoplasms / diagnosis*
Neoplasms / urine
Reagent Kits, Diagnostic / standards*
Research Design
Saliva / chemistry
Sensitivity and Specificity
Translational Research, Biomedical / methods*
Validation Studies as Topic

Substances

Biomarkers, Tumor
Reagent Kits, Diagnostic

Abstract

Publication types

MeSH terms

Substances

Grants and funding