23andMe Asks NIH, FDA for Help

In a letter, 23andMe asks Francis Collins, director of the National Institutes of Health, and Margaret Hamburg, commissioner of the Food and Drug Administration, to help develop consistency among genetic testing companies. 23andMe says uniformity is particularly needed in validating and reporting customer data and that will then reduce consumer and physician confusion. In the company's letter, which is posted to its blog The Spittoon, the 23andMe team writes that they "believe that it is important to emphasize that different genetic testing companies can report inconsistent results even when based on tests with proven analytical validity" and adds that "we, as an individual company, cannot address this issue alone." 23andMe suggests that a group be formed to establish "guidelines for acceptable analytical validity, standards for the positive and negative predictive value of all tests" and common "'best practices' for all companies," which would require transparency in reporting the predictive values of their tests.