(Dick Eastman’s Daily Newsletter – October 13, 2015)
Ancestry.com is talking to the FDA about using DNA to estimate disease risk for the company’s member base. CEO Tim Sullivan revealed the news in an interview with The Verge, effectively announcing his company’s intention to eventually offer straight-to-consumer genetic testing.
Ancestry is currently in the “very early stages of a conversation with the FDA,” Sullivan told The Verge. “We think it’s totally appropriate that the FDA has stepped in to pretty aggressively regulate direct-to-consumer genetic tests—and we’re just starting from that perspective, and trying to work very closely with them,” he continued.
This seems to make sense as a few months ago Ancestry entered into a partnership with Google-backed anti-aging startup Calico, to mine its genetics database for useful information. (See my earlier article at http://goo.gl/s5JuOj for details of that partnership.) However, there is one possible impediment.
In 2013, Ancestry rival 23andMe was barred from offering commercial genetic testing by the FDA. Earlier this month, however, the FDA opened the door for 23AndMe to offer limited straight-to-consumer tests for a rare disorder called Bloom syndrome, whose carriers are at higher risk of getting cancer. Is this a signal of a change by the FDA? Will the agency now allow corporations to become more involved in direct-to-the-consumer DNA testing as is already allowed in most other countries?