Dec 11, 2013 | Compliance, Legal, and Malpractice, Digital Pathology, Instruments & Equipment, Laboratory News, Laboratory Pathology, Laboratory Sales and Marketing, Management & Operations
FDA’s assertion of power to regulate genetic tests is a familiar argument to pathologists and clinical laboratory scientists, but does create problems for 23andMe It has been national news since November 22, when the Food and Drug Administration (FDA) sent a letter to 23andMe ordering it to stop the sale of direct-to-consumer genetic tests. The FDA said that 23andMe had failed to prove the validity of its genetic tests and gave the company 15 days to respond and identify the steps it would...
