"Personalized Genetics" Testing Shut Down by FDA November 26, 2013 San Francisco Medicine 23andMe, Commercialized Genomics, San Francisco Medicine, SFM 0 The November issue of San Francisco Medicine contains a "perspective" piece titled "Commercialized Genomics: Caveat Emptor" by SFMS staff member Steve Heilig. He warned of inaccurate test results, lack of verifiable and useful interpretation, and heavy marketing by for-profit companies such as Silicon Valley's "23andMe," which analyzes saliva samples and makes all manner of vague claims about the benefits of such tests. Many physicians have expressed great skepticism about such test results and even frustration with patients asking about such testing - at the expense of better diagnoses and interventions. Lo and behold, in what the New York Times calls a "scathing" letter, the FDA has just told 23andMe to cease offering such tests, citing the uncertainties about accuracy and usefulness, including 23andMe's aggressive marketing. The story immediately was prominently featured in all manner of media - but SFMS was there first! The San Francisco Medicine piece: http://issuu.com/sfmedsociety/docs/november_87ac85d9aa076d/21?e=3533752/5511447 The FDA's directive: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm376296.htm The New York Times coverage: http://www.nytimes.com/.../fda-demands-a-halt-to-a-dna... Comments are closed.
