23andMe Gains U.S. FDA Approval for First Genetic Test KitsCaroline Chen and Anna Edney
23andMe Inc., the genetic-testing company backed by Google Inc., gained U.S. regulatory permission to sell consumers its first screening kit to detect whether they carry the risk of a rare genetic disorder.
The approval of 23andMe’s test for Bloom syndrome, which is associated with short stature, sun sensitivity and higher cancer risk, ends a conflict with the Food and Drug Administration. The agency, in its approval notice on Thursday, also announced it intends to exempt other such “carrier screening tests” from premarket review.
23andMe, 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 a standoff began with the FDA in late 2013. Sales took a “big hit” and the Mountain View, California-based company has only recently recovered, partly by selling the health analyses outside the U.S., Chief Executive Officer Anne Wojcicki said in a January interview.
Consumers will once again be able to start buying a test with some health analysis “sometime this year,” Wojcicki said in a telephone interview Thursday. “Like the old product, it will be continuously updated and more reports will be added” as 23andMe gets further approvals, she said.
The approval also opens the way for 23andMe to pursue its ambitious plan to become a repository for humanity’s genetic makeup, and to turn data gathered from $99 saliva tests sold to consumers into multimillion-dollar deals with drugmakers who want the information to help develop drugs. The company signed deals with Roche Holding AG’s Genentech unit and Pfizer Inc. in January, and said more partnerships were on the way.
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. The FDA has been searching for a way to more efficiently regulate devices that can detect a variety of disease risks. While diagnostic tests have required clinical studies to prove reliability, on Friday the FDA will discuss a regulatory approach that would accept information culled from genetic databases to allow for faster approval.
In announcing the approval of 23andMe’s test, the agency said it planned to “create the least burdensome regulatory path for autosomal recessive carrier screening tests with similar uses to enter the market.”
The agency said this type of testing is performed on people who have no symptoms of a genetic disorder but may be at risk for passing a disease on to their children.
“The FDA believes that in many circumstances it is not necessary for consumers to go through a licensed practitioner to have direct access to their personal genetic information,” said Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health.
“Today’s authorization and accompanying classification, along with FDA’s intent to exempt these devices from FDA premarket review, supports innovation and will ultimately benefit consumers,” Gutierrez said in a statement. “These tests have the potential to provide people with information about possible mutations in their genes that could be passed on to their children.”
In the past year, 23andMe has focused on repairing its relationship with the FDA, submitting the test for Bloom syndrome in May.
To get the test approved, 23andMe had to prove to the FDA that consumers understood the health information being presented, Wojcicki said. This involved finding people who hadn’t used 23andMe and asking them to fill out questionnaires after being presented with 23andMe’s educational materials.
Now that the first test is approved, “we know the recipe we need to follow” to gain further approvals, said Kathy Hibbs, the company’s chief legal and regulatory officer.
The FDA said Thursday that if 23andMe intends to sell its test “over the counter,” the company would be required to provide information to consumers about how to obtain access to a geneticist to help them understand the results.