WASHINGTON (AP) – Genetic testing company 23andMe is reintroducing some health screening tools that federal regulators forced off the market more than two years ago, due to concerns about their accuracy and interpretation by customers.
The Google-backed company said Wednesday it will again offer 35 tests that tell users whether they carry genetic mutations for rare diseases like cystic fibrosis, which can be passed from parents to children.
The relaunch comes as the Silicon Valley company works to mend its relationship with the Food and Drug Administration and medical experts who have criticized the company’s direct-to-consumer approach. FDA officials ordered 23andMe to stop selling its health-related tests in 2013, saying they required federal review. The agency FDA signed off on the returning tests earlier this year.
CEO Anne Wojcicki said 23andMe submitted studies to the FDA showing that users can understand genetic test results without the aid of a doctor or health counselor.
“Today we’ve successfully established a framework for working with the FDA to bring back reports directly to the consumer,” Wojcicki said in an interview. “And we’ll continue to work to try and bring all of this information back.”