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What's the FDAs Concern with Direct-to-Customer Genetic Analysis?

By December 23, 2012

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A handful of companies have been offering genetic analysis for several years. However, much of the information provided relates to health care issues. For example, depending on the service, some clients may find they have particular gene variants that put them at elevated risk for certain diseases. Is this providing medical advice? Who is interpreting the data? Should access to these tests be provided through healthcare providers like blood tests and other medical diagnostics are.

Although the FDA is looking into these questions too, the answers are not so simple. Our DNA tells us all kinds of information about ourselves and, actually, we really don't know enough to interpret most of it yet. Results from genetic analysis are not as simple or as clearcut as those from blood tests. DNA analysis provides very complex data that requires sophisticated interpretation. Also, the interpretation can evolve as new research results discovery previously unknown connections and implications of different genetic variations. However, since it is your DNA, shouldn't you have the right know what's in it?

For a discussion of the regulatory concerns around genetic analysis, take a look at Direct-to-Consumer Genetic Analysis and FDA Regulation: Who Decides If You Can Get Your DNA Analyzed?

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