FDA Panel Recommends Physican Input for Genetic Tests

March 11, 2011

March 15, 2011 | At the FDA's Molecular and Clinical Genetics Advisory Panel last week, the panel again recommended that certain at-home genetic tests not be used without the involvement of a physician or genetic specialist. Some results of direct-to-consumer genetic tests, for example a person's likelihood of developing heart disease, are of limited utility without a physician's input, the panel agreed. The panel wasn't clear on whether that would mean a physician would have to order the test, or if a physician would have to interpret the test, or both. That will ultimately be up the FDA to decide. The agency -- which may decide to make certain tests that are currently DTC available by prescription only -- isn't required to follow the advice of its advisory committees, but it often does. Medpage Today