To the Editor Reading the Viewpoint by Mr Downing and Dr Ross1 about the US Food and Drug Adminstration’s mandated withdrawal of 23andMe’s Personal Genome Service (PGS), I was confident the authors were working toward a conclusion stating the need to establish analytical as well as clinical validity. However, the authors concluded “When it becomes clear that the sequencing process used by the PGS is accurate, the use of this product could be allowed under the supervision of a physician.” This conclusion indicates analytical validity only.
van Rossum LGM. Withdrawal of Personal Genome Service. JAMA. 2014;311(23):2441. doi:10.1001/jama.2014.5570