The genetic test kit from 23andMe.
Cyrus Farivar
As a major boost for 23andMe, the Food and Drug Administration has allowed the direct-to-consumer genetics Silicon Valley startup to use its kit to test for a serious genetic condition known as Bloom syndrome.
In November 2013, the FDA ordered 23andMe to stop marketing and selling its kits as a way to test for genetic health information. This is the first time the FDA has allowed an at-home genetic test for carrier screening. (Ars examined the state of direct-to-consumer genetic testing in April 2014.) Since the 2013 ban, 23andMe customers have only been able to use the service as a way to learn about their genealogy.
According to the National Institutes of Health, Bloom syndrome is “an inherited condition characterized by short stature, sun-sensitive skin changes, an increased risk of cancer, and other health problems.”
“The FDA believes that in many cases it is not necessary for consumers to go through a licensed physician to get direct access to their personal genetic information,” said Alberto Gutierrez, a director of the FDA’s Center for Devices and Radiological Health. , in a statement on Thursday.
“Today’s approval and associated classification, along with the FDA’s intent to exempt these devices from FDA pre-market review, supports innovation and will ultimately benefit consumers,” Gutierrez said. “These tests have the potential to give people information about possible mutations in their genes that could be passed on to their children.”
In a statement on Thursday, 23andMe CEO Anne Wojcicki said, “While this authorization is only for a single carrier test, we are committed to providing U.S. customers with health information once more tests have gone through this process and we have a more comprehensive product.” to offer.”