FDA to review 510(k) for 23andMe health report

Personal genomics company 23andMe Inc. (Mountain View, Calif.) said FDA accepted for review a 510(k) application for a single-condition health report for Bloom syndrome using the company's Personal Genome Service (PGS). The submission includes validation data covering major PGS components, including the genotyping chip, software and saliva kit. Bloom syndrome is a rare inherited disorder causing short stature, sun sensitivity, increased cancer and other health risks. ...