Abstract
Despite the significant advantages of metabolomic biomarkers, no diagnostic tests based on metabolomics have been introduced to clinical use. There are many reasons for this, centered around substantial obstacles in developing clinically useful metabolomic biomarkers. Most significant is the need for interdisciplinary teams with expertise in metabolomics, analysis of complex clinical and metabolomic data, and clinical care. Importantly, the clinical need must precede biomarker discovery, and the experimental design for discovery and validation must reflect the purpose of the biomarker. Standard operating procedures for procuring and handling samples must be developed from the beginning, to ensure experimental integrity. Assay design is another challenge, as there is not much precedent informing this. Another obstacle is that it is not yet clear how to protect any intellectual property related to metabolomic biomarkers. Viewing a metabolomic biomarker as a natural phenomenon would inhibit patent protection and potentially stifle commercial interest. However, demonstrating that a metabolomic biomarker is actually a derivative of a natural phenomenon that requires innovation would enhance investment in this field. Finally, effective knowledge translation strategies must be implemented, which will require engagement with end users (clinicians and lab physicians), patient advocate groups, policy makers, and payer organizations. Addressing each of these issues comprises the framework for introducing a metabolomic biomarker to practice.
Highlights
A “biomarker”, as defined in 1998 by the National Institutes of Health Biomarker’s DefinitionsWorking Group, is “a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention” [1]
The majority of biomarkers currently in clinical use are based on genomics, transcriptomics, and proteomics, and more recent biomarker developments have been based on multiplexed measurements
Why are metabolomic biomarkers not emerging for use in the clinic? The purpose of this paper is to identify obstacles to metabolomic assay development and to propose a framework for more efficient assay development
Summary
A “biomarker”, as defined in 1998 by the National Institutes of Health Biomarker’s Definitions. The metabolome may be a much closer molecular representation of phenotype and present state of health or function than any biomarker that is based on the genome, transcriptome, or proteome. It is the dynamic nature of the metabolome, as well as its close relationship with phenotype, that has stirred substantial interest in the research community. A metabolomic biomarker, is not just a string of changes in individual metabolites Rather, it is comprised of groups of co-related metabolites that change in concert; it is a meta-biomarker. We speculate that adherence to these principles will accelerate effective introduction of metabolomic biomarkers to clinical use
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