FDA gives nod to 23andMe for no-prescription breast cancer gene testing



The authorisation allows 23andMe to provide customers with information on three genetic variants known to be associated with a risk for breast, ovarian, and prostate cancer.

"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", said Anne Wojcicki, 23andMe CEO and co-founder, in a press release.

The FDA has approved a 23andMe's cancer risk test, one that provides the results directly to the consumer rather than to a doctor who would then provide their patient with info. An oncologist at Florida Hospital says these mutations are uncommon in the general population, which means that even if it comes back negative, it doesn't mean a person won't develop the disease.

US consumers soon will be able to test themselves at home for some genetic mutations that increase the risk of breast, ovarian and prostate cancer - but you might want to think before you spit. "The use of the test carries significant risks if individuals use the test results without consulting a physician or genetic counselor".

By analyzing DNA collected through a saliva sample, the test detects increased risk of developing breast, ovarian or prostate cancer. "Women with one of these variants have a 45-85 percent chance of developing breast cancer by age 70". It's the first approved test of its kind, however, and it hints at a future where those who aren't willing to wait for formal screenings (or are denied access) can take action early enough to potentially prevent cancer. "I think genetic testing is best used in the context of all of your ongoing medical care". Dr. Giblin says the competition could help drive down the cost of genetic tests at the doctor's office that can cost around $3,000.

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"One thing I want people to think about is how prepared you are for this information", she said.

Also, she said, "You have to think about family dynamics", among relatives who share your genes.

It doesn't find all cancer-causing genes - not by a long shot, the FDA said.

The variants may also be associated with an increased risk for certain other cancers.

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