The U.S. Food and Drug Administration sent a warning letter to privately held gene testing company DNA4Life over its sale of an unapproved direct-to-consumer gene test to predict drug response.   In its letter, posted on Monday, the agency said it was unable to identify any FDA clearance for the company’s test. The letter follows […]

Just as 23andMe has made peace with the US Food and Drug Administration, another direct-to-consumer genetics company is testing the regulatory waters with the launch of a $249 DNA test designed to predict drug response. The test, from tiny startup DNA4Life based in Mandeville, Louisiana, comes in the wake of 23andMe’s two-year tussle with the […]

Genetics company 23andMe announced the launch of a new consumer genetic test service on Wednesday that will show whether an individual carries genes associated with 36 different disorders, such as cystic fibrosis. The launch is a major step for the company, which in 2013 was ordered by the Food and Drug Administration to stop selling […]