After Public Shaming in 2013, 23andMe Aims to End FDA Standoff

23andMe Inc., the genetic-testing startup, is pushing to get its first agreement with U.S. regulators on a test for a disorder by this year, a turnabout after being criticized by the U.S. Food and Drug Administration for not cooperating with its approval process.

The company, which scans people’s saliva to provide information on their ancestry and inherited features, hasn’t been able to include health analysis in its reports since the standoff began with the FDA in late 2013. Sales have taken a “big hit,” and the company has only recently recovered, partly by selling kits outside the U.S., Chief Executive Officer Anne Wojcicki said.

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