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Sure Genomics whole-genome direct-to-consumer test pushes regulatory limits

| | February 16, 2016

The GLP aggregated and excerpted this blog/article to reflect the diversity of news, opinion and analysis.

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.

It’s been three years since the now-famous genetics company 23andMe first received a warning letter from the FDA telling them to stop marketing its Personal Genome Service. At the time, the FDA said that some of the intended uses for the service — uses like determining a person’s drug response or their genetic risk for breast cancer — were “concerning.” The FDA feared patients could be put at risk if they received incorrect test results, or if they didn’t understand the results they got.

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

The GLP aggregated and excerpted this article to reflect the diversity of news, opinion, and analysis. Click the link above to read the full, original article.
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