A View from Susan Young Rojahn
23andMe Puts Health Reports on Hold
Personal genetics company 23andMe will only sell ancestry reports and raw data as controversy with regulators continues.
Late on Thursday, 23andMe announced it would not provide reports interpreting health traits based on genetic data to new customers during its ongoing battle with the U.S. Food and Drug Administration.
Nearly two weeks ago, the FDA ordered the California-based company to stop marketing its consumer genetics test because it provides health-related information that the regulatory agency says must first be validated and approved for sale (see “FDA Orders 23andMe to Stop Genetic Tests”). Until last night, 23andMe continued to offer its test to new customers through its website and had issued a single tepid public response to the warning letter via a company blog post last week.
Now, the embroiled company says it will no longer provide the contentious health reports to new customers. However, customers can still purchase a personalized genetic test from the company that will analyze an individual’s ancestral makeup and allow individuals to download the raw genotyping data on which the company builds its analyses (the ancestry reports and raw data were available to customers previously, as well).
On its website, the company says customers who purchased their spit kits prior to November 22 will continue to have access to that information. However, the company will stop updating existing and adding new health reports for customers.
Customers who purchased their kits on or after November 22 will not receive any health-related data, the company says. In the future, these customers may be able to get their health-related results should the test be approved by the FDA. Such recent customers also have the option of getting a full refund for the $99 test.
There is no mention of how the company will address the FDA’s concerns that 23andMe has not provided validation requested more than a year ago nor why it stopped communicating with the agency for some six months starting May this year.