23andMe gets FDA green light for cancer risk test

Genetic testing powerhouse 23 andMe 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 forthcoming kit, which will be made available without a prescription, exams for BRCA1 and BRCA2, which are linked to higher danger of ovarian, violate and prostate cancer.

“Being the first and only direct-to-consumer genetics company to receive FDA authorization to test for cancer danger without a prescription is a major milestone for 23 andMe and for the consumer, ” the company’s CEO Anne Wojcicki said in a release tied to the proclamation. “We believe it’s important for consumers to have direct and affordable access to this potentially life-saving info. We will continue pioneering a track for greater access to health info, and promoting a more consumer-driven, preventative approach to health care.”

Of course, the test shouldn’t be taken as the be all, end all of cancer hazard — nor is it meant as a replacing for a proper screening. As geneticist Eric Topol notes on The Verge, the three variants tested here only make up a small percentage of hundreds of known mutations. The exam has the potential to offer a false sense of safety among consumers.

Topol’s warning reflects an FDA letter sent to the service back in 2013, advising 23 andMe to discontinue marketing its Saliva Collection Kit and Personal Genome Service.

“Some of the uses for which PGS is intended are particularly concerning, ” the FDA writes, “such as evaluations for BRC-Arelated genetic risk and drug reactions( e.g ., warfarin sensitivity, clopidogrel response, and 5-fluorouracil toxicity) because of the health risks health consequences that could result from false positive or false negative appraisals for high-risk indications such as these.”

The three variants of the gene are seen most often in people of Ashkenazi Jewish descent, with one in 40 people of that background carrying one. In women, the presence of one of the variants increases breast cancer hazard by up to 85 percent before age 70. As the service notes, about half of BRCA carriers who offered medical history in a study don’t report cancer history among immediate relatives.

In that respect, the service to have been able to raise a red flag and lead a user to get an additional screen. But, of course, the results of the test should in no way be taken as a replacement for a visit to the doctor.

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