Direct-to-consumer genetic testing not ready for prime time

David Hunter, Vincent L. Gregory Professor in Cancer Prevention and Dean for Academic Affairs at Harvard School of Public Health (HSPH), recently added to the commentary about direct-to-consumer genetic testing company 23andMe, which has run afoul of the FDA over its marketing claims and questions about its technical accuracy.

The company provides consumers with an analysis of their genetic susceptibility to hundreds of diseases, along with a disclaimer that the information is intended for educational and not diagnostic purposes. This troubles experts including Hunter, who worry that viewing the test results without the guidance of a medical professional may prompt consumers to undergo procedures they don’t need.

“Any reasonable interpretation would assume this is news you can use, until you get to the disclaimer,” Hunter told the Los Angeles Times in a December 15, 2013 article. “The problem is we are notoriously poor at estimating risk and communicating relative and absolute risk,” he said. Hunter also cautioned that the science of predicting disease risk from genetic data is still at a very early stage.

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Department of Genetics and Complex Diseases