Update: 23andMe appeases FDA

FDA v LDTIn an effort to quiet the storm, 23andMe has announced that it does intend to continue seeking FDA approval and that, while that process is ongoing, it will no longer provide health-related information to new customers. Customers whose Personal Genome Service® kits were ordered prior to November 22, 2013 will still have access to that information; however, customers whose PGS was ordered after the FDA warning letter will only have access to ancestry information and their raw data. The company also announced that it would offer a refund to those who ordered the PGS on or after November 22, 2013.

So is this a victory for the FDA? Is this a loss for 23andMe? A setback for consumers? A win for anyone?

Like it or not, the FDA just made third-party, independent analysis providers much more important than they had been two weeks ago. Access to raw data —which the FDA is, again, apparently not trying to stop—enables the consumer to take their data elsewhere for interpretation. The International Society of Genetic Genealogists, or ISOGG, has maintained a list of such online independent providers, including Promethease, which allows an individual to upload their raw 23andMe data file and provides the user with a breakdown of “good news,” “bad news,” “these seem interesting,” and the like. In the past, these tools have been noticeably less nuanced and less user-friendly than the 23andMe interface. But perhaps such entrepreneurs will have new incentive—at least in the short term—to upgrade their services to take advantage of 23andMe’s decision to appease the FDA.

Filed under: Badges, Direct-to-Consumer Services, FDA LDT Regulation, Genetic Testing/Screening, Genomics & Medicine, Genomics & Society, Pending Regulation, Uncategorized