23andMe scores small victory in FDA battle over DNA testing kits

Biotech company 23andMe took a step toward resuming the sale of its home genetics testing kit on Thursday when the U.S. Food and Drug Administration recognized the company could accurately test customers’ for Bloom syndrome, an inherited physical disorder.

The measured recognition that 23andMe, a firm in Mountain View run by Anne Wojcicki, the wife of Google co-founder Sergey Brin, can provide accurate and legitimate lab results on genetic diseases bodes well for the company’s ambitions to resume selling home DNA testing kits.

After a protracted battle with the company, the FDA in November 2013 compelled 23andMe to stop offering some of its genetic testing services after regulators questioned the accuracy of the results and warned of the danger of consumers receiving life-changing health information that doesn’t come from a doctor. By that time, 23andMe had collected the DNA of 550,000 customers, and was offering tests on a wide range of genetic disorders. Customers could buy a kit for $99, mail back a vial of saliva and wait for results.

Since then, 23andMe has been negotiating with the FDA to get its home testing kit back on the market. In its ruling Thursday, the FDA said the company can sell directly to consumers home tests that will determine if someone is a genetic carrier of the Bloom syndrome, a disease characterized by short stature, low weight, sun-sensitive skin changes, an increased risk of cancer and other health problems. The FDA arrived at that ruling after 23andMe performed two separate studies to demonstrate that their test is accurate in detecting Bloom syndrome carrier status. Each study looked at more than 100 saliva samples.

Despite the FDA’s ruling, 23andMe will not immediately start selling Bloom syndrome tests. Rather, the company will continue to work to get approval from the FDA on tests for other diseases. It wants to be able to resume selling the full DNA testing kit that made it famous, and not test for a single disease.


Photo: Co-founder and CEO of 23andMe Anne Wojcicki. By Dai Sugano/ Bay Area News Group.


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