Sure Genomics wants to sell private genetic profiles for $2,500, but it’s really testing the FDA

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.

"We have been in contact with the FDA and we feel like we've built a system and process that would meet their requirements," says Sure Genomics co-founder Rick White, a software developer. "[Our] reports are...