to the editor: In their Perspective article (March 13 issue),1 Annas and Elias state that the conflict between the genetic-testing company 23andMe and the Food and Drug Administration (FDA) concerns analytic and clinical validity, clinical utility, and ethical, legal, and social issues. However, their discussion is limited to a domestic U.S. perspective. After a person's raw genetic data have been determined from a DNA sample, the data are stored remotely and can be accessed easily anywhere in the world. For example, in Japan, maternal blood samples from Japanese mothers undergoing noninvasive prenatal testing are sent to an American company to be analyzed, and their data are sent back to Japan.2 Therefore, genomic digital data are trans-border. Any regulatory framework for the genome business should be based not solely on domestic laws but on an international harmonization.3'5 We would be grateful if the authors would comment on this.
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