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 23andMe’s limited relaunch last month of a series of direct-to-consumer tests after the agency ordered the tests off the market.
DNA4Life told Reuters in an earlier interview that it did not believe it needed FDA approval to sell its test.
(Reporting by Julie Steenhuysen Editing by W Simon)
Source: Reuters Health