(Recasts throughout, adds company, FDA comment)
By Julie Steenhuysen
CHICAGO, March 6 (Reuters) - Genetic testing company 23andMe on Tuesday won U.S. Food and Drug Administration approval to sell genetic tests for three key breast cancer mutations directly to consumers, a coup for the company that has been gradually winning approval for such tests after FDA banned its Personal Genome Service in 2013.
Last April, the FDA agreed to allow Alphabet-backed 23andMe to sell direct-to-consumer genetic predisposition tests for 10 diseases, including Parkinson's, Alzheimer's and Celiac disease.
Tuesday's approval will allow 23andMe to sell a test that detects three BRCA mutations that increase a woman's genetic risk of breast and ovarian cancer and a man's risk for prostate cancer. The mutations represent the three most common breast cancer risk genes for people of Ashkenazi Jewish descent.
Anne Wojcicki, 23andMe CEO and co-founder, said in a statement that being allowed to sell the test to consumers without a prescription "is a major milestone."
"We believe it’s important for consumers to have direct and affordable access to this potentially life-saving information."
BRCA mutations account for about 50 percent of hereditary breast cancers and up to 65 percent of those who inherit the mutations will develop breast cancer.
Donald St. Pierre of the FDA's Office of In Vitro Diagnostics and Radiological Health said in a statement announcing the approval that the test is intended for people who might not otherwise get genetic testing, adding that "it has a lot of caveats."
Only a small percentage of Americans carry one of the three mutations, and most of the 1,000 known BRCA mutations that increase an individual’s cancer risk are not included in the test. The test should not be used as a substitute for regular cancer screenings, he said.
The FDA also cautioned against using the results to make treatment decisions, such as anti-hormone therapies or the surgical removal of the breast or ovaries. Those decisions should be based on confirmatory tests and genetic counseling.
And FDA warned that the tests, which work by analyzing saliva samples, carry significant risks for individuals if they are used without consulting a doctor or genetic counselor.
The regulator said it reviewed data for the company's test under a pathway for low-to-moderate risk devices that are not equivalent to an already marketed device. The agency also outlined special controls designed to assure test's accuracy and reliability.
To win approval, the company submitted data showing its instructions and reports are easy to understand. They provide information on what the results might mean and where to get additional information.
In 2013, FDA objected to the sale of the company's Personal Genome Service directly to consumers because it had not approved the tests.
Reporting by Julie Steenhuysen; editing by Diane Craft