IOM Report Calls for FDA Involvement in 'Omics' Test Development

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By Alexander Gaffney

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.”

Read more:

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