FDA panel supports medical supervision of all genetic testing

10 March 2011

An FDA advisory committee has said that direct-to-consumer (DTC) genetic testing should be subject to medical supervision.

The Molecular and Clinical Genetics Advisory Committee of the US Food and Drug Administration (FDA) met from 8-9 March 2011 and reportedly expressed general agreement that ordering and interpretation of all forms of genetic testing should be via medical professionals. This follows a letter from the American Medical Association (AMA) to the panel expressing the same sentiment (see previous news).

The panel of 21 members comprises both academics and clinicians. Member George Netto of the Johns Hopkins School of Medicine reportedly commented: "It's very dangerous to get a false reassurance when you don't know about environmental and other risk factors". Concerns about false reassurance of low disease risk, or unnecessary alarm at perceived high disease risks, appear to be central to these calls for ongoing medical supervision for all forms of genetic testing, despite evidence that the risks of these harms may be very low (see previous news).
The FDA must now decide how to regulate these types of DTC genetic tests (see previous news), possibly distinguishing between carrier testing for heritable diseases and predictive testing for risk of adult-onset disease or response to a drug or treatment. However, this is not straightforward since tests suggesting a marginally increased risk of developing diabetes in later life are not really comparable with those identifying BRCA mutations conferring a very high risk of developing breast cancer, for example.
Consumer protection is as important for genetic testing as for other forms of health-related products and services, of course, but striking a reasonable balance is surely desirable.