An Institute of Medicine report on the issues underlying the Duke University/Anil Potti research scandal has found that there are problems with the use of genetic signatures to treat or diagnose disease, reports ScienceInsider's Jocelyn Kaiser. The report says 'omics tests are "highly prone to errors," and recommends that "they be rigorously validated before being used in clinical trials," Kaiser says. "The report also calls on journals, funders, and institutions to take steps to avoid what it calls a 'failure' of oversight that allowed problems to go unchecked at Duke." IOM committee chair Gilbert Omenn, a University of Michigan biologist, tells Kaiser that what happened at Duke was caused partially by a rush to get 'omics-based tests in the clinic.
In the future, IOM says there should be a series of tests to validate 'omics diagnostics, like repeating them on blind sample sets from multiple institutions. The report also says researchers need to "lock down" their computational models before the tests get to the clinic and consult with FDA before putting a test in the clinic, Kaiser adds.
Daily Scan's sister publication, GenomeWeb Daily News, has more on the IOM report here.