Ancestry.com, the popular genealogy site, 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 past summer, Ancestry entered into a partnership with Google-backed anti-aging startup Calico, to mine its genetics database for useful information. Thanks to the plummeting cost of genomics-related software, hardware, and research tools, genetic testing is becoming a prospective revenue stream for many companies.
Of course, there’s one rub: In 2013, the FDA famously barred Ancestry rival 23andMe from marketing direct-to-consumer genome health tests and results. 23andMe pivoted to become a heritage and genealogy service shortly afterward, providing genetic reports for ancestry. Earlier this month, however, the FDA opened the door for 23AndMe to offer limited straight-to-consumer tests, specifically to detect a rare disorder called Bloom syndrome, whose carriers are at higher risk of getting cancer. In the context of 23andMe’s announcement, Sullivan’s comments seem to indicate that the FDA is becoming more comfortable with the idea of startups offering mail-order genetic testing to consumers.
Correction: This article has been updated to more accurately reflect the FDA’s warning letter to 23andMe, which banned the company from marketing direct-to-consumer tests.