FDA Panel Says Home Gene Tests Need Doctor Input

Results of Limited Value Without Physician Involvement, Panel Said
By EMILY P. WALKER MedPage Today Washington Correspondent
March 12, 2011

GAITHERSBURG, Md. -- Certain types of genetic tests that are available for at-home use without a prescription should not be used without the involvement of a physician or genetic specialist, an FDA advisory panel recommended.

So-called direct-to-consumer (DTC) genetic tests can provide information ranging from a whether a person is lactose intolerant, at risk of developing Alzheimer's disease, or likely to respond to a certain type of drug. After taking a quick blood or saliva sample in the privacy of one's own home, the test is mailed to a laboratory for interpretation and the person is later sent his or her results.

But some of those results -- for example, a person's likelihood of developing heart disease -- are of limited utility without the involvement of a physician, agreed members of the FDA's Molecular and Clinical Genetics Advisory Panel, which wrapped up a two-day meeting on DTC testing on Wednesday afternoon.

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