The U.S. Food and Drug Administration on Thursday agreed to allow genetic testing company 23andMe to market tests directly to consumers to assess their predisposition to develop 10 diseases, including Parkinson’s, Alzheimer’s and Celiac disease.
The FDA said the tests are intended to provide genetic risk information but cannot determine a person’s overall risk of developing a disease or condition.
“In addition to the presence of certain genetic variants, there are many factors that contribute to the development of a health condition, including environmental and lifestyle factors,” the agency said in a statement.
The company’s genetic health risk reports (GHR) work by testing saliva samples for more than 500,000 genetic variants whose presence or absence may be associated with the conditions approved by the FDA.
Included in the list are Alpha-1 antitrypsin deficiency, a disorder that raises the risk of lung and liver disease, Factor XI deficiency, a blood clotting disorder, Gaucher disease type 1, an organ and tissue disorder, early-onset primary dystonia, a movement disorder, and various blood disorders.
The FDA said it reviewed data for the company’s tests under a regulatory pathway for novel, low-to-moderate-risk devices that are not substantially equivalent to an already marketed device. The agency also established criteria known as special controls clarifying its expectations for assuring the tests’ accuracy and reliability.
The FDA said 23andMe will not be required to submit additional tests for review prior to being marketed. The special controls will also act as a benchmark for other companies developing similar tests. The tests cannot be used to actually diagnose disease.
(Reporting by Toni Clarke in Washington; Editing by Dan Grebler)