FDA Approves First Home Test for Breast Cancer Genes

23andMe can now sell a genetic test for breast cancer to anyone who wants one

The test can identify three specific BRCA mutations that occur most often in people of Ashkenazi Jewish descent.

This test is far from definitive: There are thousands of mutations on the BRCA genes alone that can raise a person's risk of developing cancer, and 23 andMe's test can only identify three.

In a reversal of fortune for 23andMe, the US Food and Drug Administration (FDA) has granted the company the first-ever authorization for direct-to-consumer genetic testing for cancer risk without a prescription.

The FDA stresses that despite approving this first-of-its-kind test, the fact is that it only detects three out of 1,000 DNA abnormalities which can lead to cancer, so it shouldn't replace regular mammogram tests or trips to the doctor. The test should not be used as a substitute for regular cancer screenings, he said. It can not determine a person's overall risk of developing cancer.

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

"For all these reasons, it is important for patients to consult their healthcare professional, who can help them understand how these factors impact their individual cancer risk and what they can do to modify that risk", the statement continued.

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. Test results come in the form of a report sent to the user. 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.

Robert C. Green, a medical geneticist at Brigham and Women's Hospital, said the FDA's decision was somewhat surprising, but gratifying - and a step forward in democratizing genomic information. The agency also outlined special controls created to assure test's accuracy and reliability. The test report provides information describing what the results might mean, how to interpret results and where additional information about the results may be found.