Apr 13, 2016 | Compliance, Legal, and Malpractice, Instruments & Equipment, Laboratory Management and Operations, Laboratory Pathology
FDA sends letter to the California-based start-up concerning 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 offer direct-to-consumer whole-human genome sequencing in developments that should be watched by clinical laboratory managers and pathologists. One...