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23andMe's BRCA Test OK'd

23andMe has gotten the go-ahead from the US Food and Drug Administration to sell its genetic health risk report on three BRCA1 and BRCA2 mutations that increase a person's chances of developing breast cancer, as GenomeWeb reports. These variants are most common among people of Ashkenazi Jewish descent, though they are found to a lesser degree among individuals of other ethnic backgrounds.

"Being the first and only direct-to-consumer genetics company to receive FDA authorization to test for cancer risk without a prescription is a major milestone for 23andMe and for the consumer," Anne Wojcicki, CEO and co-founder of 23andMe, says in a statement.

However, the Scripps Research Institute's Eric Topol tells the Verge that as the test examines only those three mutations "those tested can get the false illusion that they are not carriers, when in fact they may have other of the hundreds of known functional mutations."

Similarly, the University of Washington's Mary-Claire King tells NPR that the "testing is deceptive."

"My concern is that women who carry a severe mutation and don't know it could die of breast or ovarian cancer having been misled by a result they believed to be normal when it wasn't," she says.

Indeed, in a statement, FDA warns that a negative result on the test doesn't mean an individual can't have other BRCA mutations that are not included in the test or mutations in other genes that increase disease risk. FDA adds that the test doesn't replace seeing one's doctor and that clinicians should not base treatment decisions on the test. Wojcicki, too, notes that most cancers are not hereditary, that their test doesn't include all variants that can increase cancer risk, and that people should continue to undergo cancer screenings.