2021
DOI: 10.3390/metabo11070423
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Metabolomic Laboratory-Developed Tests: Current Status and Perspectives

Abstract: Laboratory-developed tests (LDTs) are a subset of in vitro diagnostic devices, which the US Food and Drug Administration defines as “tests that are manufactured by and used within a single laboratory”. The review describes the emergence and history of LDTs. The current state and development prospects of LDTs based on metabolomics are analyzed. By comparing LDTs with the scientific metabolomics study of human bio samples, the characteristic features of metabolomic LDT are shown, revealing its essence, strengths… Show more

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Cited by 19 publications
(15 citation statements)
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“…In total, almost 70% of the global biochemical phenotype of the organism is estimated. Therefore, a metabogram can potentially be considered a personalized metabolomics tool [ 50 ].…”
Section: Discussionmentioning
confidence: 99%
“…In total, almost 70% of the global biochemical phenotype of the organism is estimated. Therefore, a metabogram can potentially be considered a personalized metabolomics tool [ 50 ].…”
Section: Discussionmentioning
confidence: 99%
“…The datasets generated from clinical trials and research studies curate for clinical databases that support diagnosis and therapeutic assessment of several disease states [7]. However, these datasets require standardization and validation to create a clinical reference guide that is applicable for any biofluid, as well as FDA approval for utilizing this platform for clinical diagnostic purposes [11].…”
Section: Metabolomics In Clinical Urinalysismentioning
confidence: 99%
“…The personalized metabolomics analysis should be scalable, fast, and understandable to wider range of people. While a metabolomics study is unique, it can take from several months to several years, and with very complex results that are intended for scientists with experience in the same field of science [ 12 , 20 ]. Figure 3 below shows the traditional needs for the analytical methods to address both the metabolomics study and personalized metabolomics, with a focus on the differences, including the standardization and treatment of data.…”
Section: The Bottle Necks Of Personalized Metabolomicsmentioning
confidence: 99%