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.
When it initially shut down the health reports, the FDA criticized the startup for not responding to the regulator’s inquiries for more than six months. In the past year, 23andMe has focused on repairing its relationship with the FDA, Wojcicki said. In May, the company submitted a new test that is limited to the detection of a rare genetic disorder called Bloom syndrome, which is associated with short stature, sun sensitivity and higher cancer risk.
The company and the agency have “quite an active dialogue, and I’d hope we’d have some resolution on that this year,” Wojcicki said.
The FDA declined to comment.
23andMe still aims to have the full test approved by the agency, she said, and proceedings should move faster once the first test is approved.
“The simplicity of the first submission enables us and the FDA to focus on not just that submission but also the overall analytics and validation of the platform,” 23andMe President Andy Page said in a telephone interview. “It was an effective way of enabling both parties to work together.”
To get its test approved, 23andMe has to show that the test is indeed providing consumers the information it claims to identify, and that it’s interpreting the results in a valid way, said Patricia Zettler, a fellow at Stanford Law School’s Center for Law and the Biosciences. The latter question is where the agency is probably focusing its attention, to determine what data the startup can provide to the agency, said Zettler, who previously worked as an attorney at the FDA.
“Whenever you’re on the cutting edge of some technology and yours is the first one getting through, there’s a process,” said Zettler, “Hopefully through this submission, the FDA might figure out a path forward that has sufficient protection for public health but also allows for innovation that’s so near and dear to Silicon Valley.”