FDA to allow limited 23andMe home genetics test

Posted at 10:31 PM, Feb 20, 2015
and last updated 2015-02-25 10:46:37-05

The banned 23andMe home genetics health report is making a return — one syndrome at a time.

The U.S. Food and Drug Administration authorized 23andMe to market a home genetics test for Bloom syndrome Thursday. It is the first time the FDA has approved a direct to consumer genetics test.

23andMe previously marketed a home genetics test and health report that claimed to analyze many potential illnesses. It was TIME’s invention of the year in 2008, but its health interpretations were banned in the U.S. in 2013.

The FDA said it lacked evidence that the test was “accurate, reliable and clinically meaningful.” 23andMe continued to sell a home saliva test and provide raw genetic information. However, analysis of that data was limited to ancestry — not potential medical conditions.

This time, 23andMe conducted studies to show that its more limited genetics test was accurate and understandable.

“These tests have the potential to provide people with information about possible mutations in their genes that could be passed on to their children,” said Alberto Gutierrez of the FDA’s Center for Devices and Radiological Health, in a statement.

If sold, the tests must provide information to point customers to a medical professional.

“We are committed to providing U.S. customers with health information once more tests have been through this process and we have a more comprehensive product offering,” said CEO Anne Wojcicki, in a statement. “We will continue to work with the FDA to ensure that all future health submissions meet the agency’s standards.”

The FDA also took steps to open the market for future home testing of certain diseases that may be carried by a parent.

Bloom syndrome is a rare disease, more common among some Jewish populations, that often results in an early death from cancer. A parent can carry the gene and pass it on to their children without themselves having the disease.

Gavin Stern is a national digital producer for the Scripps National Desk.