Sure Genomics, a startup based in Utah, launched a genetic testing service today that costs a whopping $2,500 upfront, with an additional $150 subscription fee that guarantees DNA analysis updates every six months. The price is unusually high for a direct-to-consumer genetics company, since 23andMe and Ancestry offer genetics reports for $199 and $99, respectively. But Sure Genomics says it’s worth it; customers who pay the fee will get their entire genome sequenced, and unlike others, the startup says it won’t sell anonymized genetic information to third parties to turn a profit.

But from a regulatory standpoint, Sure Genomics is treading on thin ice. The FDA has warned similar companies about telling people their disease risk or how their bodies might respond to a drug. Sure Genomics plans to deliver exactly those kinds of results — without getting clearance from the FDA first.

…

Hank Greely, a Stanford University law professor and bioethicist, says he “would be surprised” if Sure Genomics’ use of a prescribing physician changes the FDA’s view of the company’s offerings. That’s because consumers will still have unmediated access to results, he says. There isn’t an exact precedent for a physician-based approach, however, so the FDA’s reaction is “at least somewhat unclear,” he says. Mark Rothstein, director of the Institute for Bioethics, Health Policy and Law at the University of Louisville, also doubts regulators will be lenient because a prescribing physician is involved in the ordering process. “I don’t think getting a doctor to order the test changes anything.”