FDA Approves First Direct-To-Consumer Genetic Cancer Risk Test

SILICON VALLEY, CA — Mountain View-based 23andMe has received the U.S. Food and Drug Administration's authorization to market a direct-to-consumer genetic test for cancer risk — the first of its kind to be approved by the FDA. Specifically, according to the FDA, 23andMe is now authorized to market a personal genome service genetic health risk — GHR — report for three BRCA1/BRCA2 breast cancer gene mutations most common in people of Ashkenazi (Eastern European) 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," said Anne Wojcicki, 23andMe CEO and co-founder.

The tests will report on three variants in the BRCA1 and BRCA2 genes associated with a significantly higher risk of breast and ovarian cancer in women, and breast cancer in men, according to a 23andMe news release. The variants may also be associated with an increased risk for certain other cancers.

The three variants are most prevalent in those of Ashkenazi Jewish descent, and have been observed at much lower rates in other ethnicities, the company stated. About 1 in 40 individuals of Ashkenazi Jewish descent has one of the three variants. Women with one of these variants have a 45- to 85-percent chance of developing breast cancer by age 70.

The FDA said it reviewed data for the test and established criteria with expectations for ensuring the test’s accuracy, reproducibility, clinical performance and labeling.

The FDA noted, however, that the three variants are not the most common BRCA1/BRCA2 mutations among the general population.

"This authorization is incredibly valuable for those who might not be aware of their Ashkenazi Jewish descent or aren’t familiar with their family history of cancer," Wojcicki said. "But it’s important to understand that the majority of cancer is not hereditary, our test does not account for all genetic variants that can cause a higher risk of cancer, and people should continue with their recommended cancer screenings."

New and existing 23andMe Health + Ancestry Service customers who were genotyped on the company’s most recent platforms will have access to the GHR report in the coming weeks, according to the company. Customers must specifically choose for themselves if and when they want to receive the information, which also includes "an education module to ensure customers are fully informed on what they can learn from this report and how to use the results," 23andMe said in a news release.

"We believe it’s important for consumers to have direct and affordable access to this potentially life-saving information," Wojcicki said. "We will continue pioneering a path for greater access to health information, and promoting a more consumer-driven, preventative approach to health care."

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