Feb 26, 2014 – 23 And Me

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ANCHOR LEAD: ARE GENETIC TESTS BEING CALLED INTO QUESTION BY THE FDA’S RECENT ACTION
REGARDING 23 AND ME? ELIZABETH TRACEY REPORTS

23 and Me is a genetic testing company that offers DNA sequencing services with an eye toward assessing someone’s risk of certain diseases, but the FDA has recently shut them down. Why? William Nelson, director of the Kimmel Cancer Center at Johns Hopkins, says it’s not because genetic testing isn’t helpful.

NELSON: We already use a number of gene tests that are associated with specific disorders. When we do that we get information on the defect. We couple that information with advice from physicians and other health care professionals. If you just provide this information in the absence of that advice from the health care professionals it may be misinterpreted, misconstrued and misused, and I think that’s what the FDA wanted to do in its regulatory environment. :28

Nelson says that with regulation, 23 and Me and other genetic testing companies are providing a useful service that will likely benefit many of us as a more complete picture of genes and diseases emerges. At Johns Hopkins, I’m Elizabeth Tracey.