Journal
JOURNAL OF MASS SPECTROMETRY
Volume 53, Issue 11, Pages 1143-1154Publisher
WILEY
DOI: 10.1002/jms.4292
Keywords
assay development; biochemical phenotype; biochemistry; biomarker; chromatography; clinical; Clinical Laboratory Improvement Amendments (CLIA); College of American Pathologists (CAP); laboratory developed test (LDT); longitudinal analysis; mass spectrometry; metabolomics; quality control; validation
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For over a decade, metabolomics has been promising to transform the practice of medicine by delivering powerful diagnostic tests. The reality, however, is that the march towards precision medicine has been slower than first anticipated because of the substantial challenges associated with the development, validation and adoption of complex multivariate testing strategies within a highly regulated environment. In this issue, Kennedy and colleagues present their vision for the future of untargeted metabolomics in clinical testing. They highlight the complexities of test design, accurate and precise data acquisition, quality control, data processing and biochemical pathway analysis when hundreds to thousands of unique metabolites are measured in a single clinical sample. The authors outline the current state of (mass spectrometry-based) metabolomics and illustrate the both the potential, and the challenges, of this rapidly evolving landscape.
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