IOM calls for more scrutiny of 'omics' tests

The Institute of Medicine issued a report on Friday that calls for increased FDA involvement in the development process of predictive tests that use "omics" technologies -- genomics, epigenomics, proteomics or metabolomics. The report says FDA should issue a risk-based guidance or regulation on bringing omics-based tests to the agency for review and on the oversight of laboratory-developed tests (LDTs). IOM said the agency should also communicate investigational device exemption (IDE) requirements for use of omics-based tests in clinical trials.

The report includes recommendations for other stakeholders, including institutions, investigators, and funders. IOM said institutions and investigators should discuss tests and intended uses with FDA prior to validation studies and clinical studies, even if an IDE is not required. IOM recommends institutions and investigators be required to make data and computational procedures used to develop tests publicly available, and said the agencies and companies that fund omics research should support the cost of an independently-managed database for this information. ...