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

Posted 26 March 2012 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

Share this article:

Categories: FDA

Tags: LDTs, Epigenomics, Metabolomics, Proteomics, Genomics, Recommendation, Omics, IOM, Report, Latest News, study, guidance

Regulatory Exchange: Latest Updates From the Community