23andMe gets FDA approval for BRCA cancer risk DNA test

23andMe gets FDA approval for BRCA cancer risk DNA test

It's called 23andMe, and tests for three of the more than 1,000 genetic mutations linked to breast cancer.

The FDA statement emphasized that a negative test does not rule out the possibility that a person has an increased cancer risk associated with other types of genetic mutations, including BRCA and non-BRCA mutations.

However, this does not find all genes that cause cancer, the FDA cautioned.

"There are other genes besides BRCA1 and BRCA2 for breast cancer, and there are lots of other mutations on BRCA1 and BRCA2 that aren't being tested".

"This test provides information to certain individuals who may be at increased breast, ovarian, or prostate cancer risk and who might not otherwise get genetic screening and is a step forward in the ability of direct-to-consumer genetic tests". 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 variants are found most commonly in people of Ashkenazi Jewish descent - they are "not the most common BRCA1/BRCA2 mutations in the general population", the FDA said in a statement. It can not determine a person's overall risk of developing cancer.

The approval comes four years after the FDA threw the brakes on 23andMe's race across the consumer genetic testing landscape in a November 2013 warning letter that amounted to a cease-and-desist order.

According to a National Cancer Institute study, about 2% of Ashkenazi Jewish women carry 1 of the hereditary mutations the test can detect.

Statistics show roughly one in eight women will develop invasive breast cancer over the course of their lifetime.

And the FDA said no doctor or patient should use the test as a basis for deciding treatment, "including anti-hormone therapies and prophylactic removal of the breasts or ovaries".

The three DNA mutations searched for in the screening make up a small percentage of hundreds of known BCRA mutations. As with the first 10 tests, the company is authorized to provide the results directly to the customer.

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