23andMe Granted FDA-Approval for Genetic Test on Cancer Risk

The FDA announced it will allow the genetic testing company 23and Me to market directly its breast cancer test that will help assess 3 mutations in a common form of breast cancer gene

Second, it only tests for 3 mutations that may cause cancer, even though there are far more, a point not lost on the FDA.

The approval will likely set off a debate over whether people can handle this type of genetic information without professional help, cancer experts said. The variants that are associated with the higher risk of cancers are most common in those of Ashkenazi Jewish descent.

"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", the company's CEO Anne Wojcicki said in a release tied to the announcement. On the other hand, those who find they do have the mutations may needlessly worry - having the mutation does not guarantee you will get cancer. The test only detects three out of more than 1,000 known BRCA mutations.

About 1 in 400 people have cancer-causing BRCA mutations.

These variants are most prevalent in those of Ashkenazi Jewish descent, and have been observed at much lower rates in other ethnicities. In women, the presence of one of the variants increases breast cancer risk by up to 85 percent before age 70. "Together, BRCA1 and BRCA2 mutations account for about 20 to 25 percent of hereditary breast cancers and about 5 to 10 percent of all breast cancers", the National Cancer Institute says.

Users report unprompted laughter from Amazon Alexa devices
Earlier this week, BuzzFeed reported that a number of people have had their Alexa speakers start laughing for no apparent reason. Other Alexa users have made similar complaints. "Our Alexa lit up and laughed for no reason".

Before you go to 23andMe's website to order a test, there are a few things you should know.

Consumers and health care professionals should not use the test results to determine any treatments, including anti-hormone therapies and prophylactic removal of the breasts or ovaries.

Genetic testing powerhouse 23andMe announced today that it's officially received the FDA go-ahead to launch a direct-to-consumer testing kit for genes linked to various forms of cancer.

The FDA approved the first test that people can get without a doctor to see if they carry a genetic mutation that increases their risk for cancer. Along with this authorization, the FDA is establishing criteria, called special controls, which set forth the agency's expectations in assuring the test's accuracy, reproducibility, clinical performance and labeling.

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