Tuesday, January 7, 2014

Standards Needed for Genome Testing Services

A number of companies now offer to test your DNA and then give you an assessment of your risk of developing certain genetic diseases and conditions. One company was warned by the FDA recently that providing people with “results” that include analysis of one’s risk of developing certain genetic diseases amounts to giving medical advice, and there was no evidence that the advice was accurate. (See this blog, Dec. 5, 2013.)

Now an enterprising reporter has shone a light on just how bad, or at least variable, the results can be. (see Piekoff, Kira. I had my DNA Picture Taken, With Varying Results. The New York Times, Dec. 30, 2013). The reporter solicited her genome test results from three different companies. The results, and the companies’ analyses of the meaning of the results, were in many cases highly variable. The findings point to the need to standardize the results and validate them for accuracy, if they are to have any usefulness to consumers. Right now, most of the so-called results of genome analysis have about the same validity as having your fortune told by a psychic. Don’t waste your money unless you just want to be entertained.

Don’t get me wrong; I’m not totally negative on the potential of genome tests. I fully expect genome analysis (and the meaning of the results) to get better and better with time and with sufficient FDA oversight. Perhaps in your lifetime you WILL be able to glean some useful information from such analysis. But not yet.

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