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After previously being warned of doing genetic risk testing for its customers, 23andMe again received U.S. Food and Drug Administration approval for its DNA test for the potentially deadly BRCA gene mutations, causing breast and other cancers.

But the approval announced Wednesday comes with caveats – and some skepticism.

“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 available of (direct-to-consumer) genetic tests. But it has a lot of caveats,” said Donald St. Pierre, an FDA official, in the role of acting director of the Office of In Vitro Diagnostics and Radiological Health in the Center for Devices and Radiological Health.

The test only detects three out of a possible 1,000 known BRCA mutations, the FDA said in its statement. The three detected in the 23andMe test are most commonly found in Ashkenazi Jewish women – roughly two percent of that group, according to the FDA.

“While the detection of a BRCA mutation on this test does indicate an increased risk, only a small percentage of Americans carry one of these three mutations and most BRCA mutations that increase an individual’s risk are not detected by this test,” added St. Pierre.

The FDA has previously sent the company a warning letter in 2013 instructing the company to immediately discontinue the Personal Genome Service, which included the BRCA test.

But the federal agency determined 23andMe had demonstrated through its data that the test is accurate in identifying the three mutation variants through the company’s standard saliva samples – and that it is reproducible. The agency determined this through the “de novo premarket review pathway,” the officials said.

Ann Wojcicki, the CEO of 23andMe, said the last four years without being able to tell customers of their potential health risks has “kept (her) up at night.”

“I can sleep better knowing that soon, if our customers choose to, they can view this information,” she said in a statement this week. “We know from our own data that this information can be incredibly meaningful for customers and, in some cases, could even save lives.”

The 23andMe announcement also highlights two cases of women who learned about their genetic risks because of the earlier version of the company’s test. One of them said “the information I gained could quite possibly have saved my life.”

The experts are urging caution with the new horizon of “DTC” genetic testing. The National Society of Genetic Counselors said experts should still be on hand to do full-through of DNA risk factors for cancer and other diseases.

“Consumers who test positive for these mutations need to be retested in a clinical setting under the supervision of a medical professional before moving forward with any medical decisions,” the NSGC said in its statement. “Those who test negative, yet have a strong family history of cancer, may be appropriate candidates for setting and should also consult with medical professionals.”

The American Cancer Society weighed in, as well – and indicated that the new approval could potentially change everything when it comes to genetic risk assessment. J. Leonard Lichtenfeld, the deputy chief medical officer of the group, said in his blog that the availability of the direct diagnostic “sounds simple” – but in reality poses whole other conundrums, like having to notify health insurers of the genetic status.

“The gauntlet has been thrown down: the government has approved a direct-to-consumer test for BRCA,” writes Dr. Len. “It is not a perfect test. It will likely get substantial publicity/advertising, and inevitably someone will not follow the suggestion as to whether they should be tested, what they should do about the results if positive, and whether they should get further testing if it could be what we call in medicine a ‘false-negative.’"

“Of this I have no doubt: this is the star of an early discussion on the value and role of genetic testing in the population at large,” adds Lichtenfeld. 

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