More than a year after it was ordered to stop selling its DNA testing kit by the Food and Drug Administration, 23andMe has received approval to market a different kind of test. The FDA said today that 23andMe has been approved to sell a test for markers of Bloom Syndrome, a rare genetic condition associated with short stature, sun sensitivity, and increased cancer risk.
It's the first time the FDA has approved this kind of "direct-to-consumer" genetic test, a form of screening that is available without physician approval. The FDA said that in the future, carrier screening tests like this one would be exempt from FDA review before they go to market, making them easier for companies like 23andMe to develop and sell.
"We are committed to providing US customers with health information."
The FDA ordered 23andMe to stop selling its full DNA analysis kit, which screened for 254 diseases, because the company had not received the necessary approvals. Among other concerns, the FDA said false positives for certain conditions could prompt people to seek radical surgeries or other treatments without doctors' input.
In a blog post, 23andMe called its approval to sell the Bloom Syndrome test "an important first step in fulfilling our commitment to return genetic health reports to consumers in the US." It continued: "While this authorization is for a single carrier status test only, we are committed to providing US customers with health information once more tests have been through this process and we have a more comprehensive product offering."