Sure Genomics Offering $2,500 Whole Human Genome Profile to Consumers, but ‘Doctor Prescribed’ Medical Laboratory Test Caught the Attention of the FDA

FDA sends warning letter to the California-based start-up for its failure to obtain clearance for SureDNA test kit before accepting pre-orders from consumers Competition to market whole-human genome sequencing to consumers is heating up. Not only is the Food and Drug Administration (FDA) watching these developments, but it is taking action to regulate companies that […]
Source: Dark Daily - Category: Laboratory Medicine Authors: Tags: Compliance, Legal, and Malpractice Instruments & Equipment Laboratory Management and Operations Laboratory Pathology 23andMe Annals of Internal Medicine clinical laboratory food and drug administration Genome Web Laboratory News Mark R Source Type: news