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Regulation and Innovation

Sales at 23andMe, the consumer genetics company, have fallen some 50 percent since last November, CEO Anne Wojcicki tells the Associated Press.

It was then that the US Food and Drug Administration sent a warning letter to the company, telling it stop selling its health test until it receives authorization from the agency. The agency said it was concerned about the validity and intended uses of the test.

As the AP notes, 23andMe is now working in a more piecemeal fashion to get its health tests cleared one at a time — its service had provided information on some 250 conditions. The company is continuing to sell its ancestry test and provide raw, uninterpreted DNA data.

"This has actually been a really good experience for 23andMe because it's taking us up a level," Wojcicki tells the AP, which notes that she's brought on four new executives with backgrounds in the health sector. "And if we can define this and if the FDA can set out the structure and the path forward, then they are going to enable an incredible amount of innovation."