The DNA analysis company 23andMe will comply with a recent Food and Drug Administration (FDA) directive and halt all health-related genetic testing until further notice. The FDA recently ordered the company to stop selling its DNA test kit, citing concerns over "the potential health consequences that could result from false positive or false negative assessments." Although it's not the only aspect of 23andMe's testing — the company also provides data on ancestry — the health screening is seen as a large reason for its success.
Following the FDA's directive 23andMe swiftly halted all marketing for the health tests, and the company has now ceased health-related testing entirely. Customers that purchased kits on or before November 21st will receive health-related analysis, but anyone buying a test from November 22nd on will only have access to ancestry information and raw test results without analysis. 23andMe notes testing will stay on hold while "the company moves forward with [the FDA's] regulatory review processes."
23andMe is "committed to finding the right regulatory path."
In a blog post announcing the decision, 23andMe co-founder Anne Wojcicki says she's "highly disappointed" to have to halt testing. Wojcicki adds that the company is "committed to finding the right regulatory path" for its customers, and will "work cooperatively with the FDA" to return to health-related testing. It's not clear if or when such tests will return to 23andMe's repertoire, but until then the company is offering a full refund to anyone that purchased a test kit on or after November 22nd.