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Posted 26 March 2012 | By Alexander Gaffney, RAC
A report issued last week by the Institute of Medicine (IOM) calls on the US Food and Drug Administration (FDA) to become involved in the development of so-called "omics"-genomics, proteomics, metabolomics and epigenomics technologies-in order to provide guidance and better evaluate products used in clinical applications.
The lack of "clearly defined development and evaluation processes has caused several problems," wrote IOM in a statement released 23 March. "The regulatory steps that investigators and research institutions should follow may be ignored or misunderstood. As a result, flaws and missteps can go unchecked."
IOM recommended FDA develop guidance for developers of omics-tests, saying "scientific and clinical progress in omics test development will be accelerated if these recommendations are broadly adopted."
IOM - Evolution of Translational Omics: Lessons Learned and the Path Forward
IOM Report Recommends Evaluation and Validation Process to Prevent Problems Associated With Turning 'Omics' Research Into Clinical Tests
Biocentury - IOM calls for more scrutiny of 'omics' tests
Tags: LDTs, Epigenomics, Metabolomics, Proteomics, Genomics, Recommendation, Omics, IOM, Report, Latest News, study, guidance
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This article provides a variety of websites with important information on recent changes to FDA guidances and tables ...