FDA approves over-the-counter test for breast cancer genes

The Food and Drug Administration has given approval to popular genetic-testing kit 23andme to allow their customers to test for genetic markers known to significantly increase a person’s chance for developing breast, ovarian and prostate cancer, the company recently announced.

23andme will provide information on three genetic variants found on the BRCA1 and BRCA2 genes. The company allows customers to discover information about their health and ancestry based on genetic testing of their DNA.

“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,” Anne Wojcicki, 23andMe CEO and co-founder, said in a statement.

The company had earlier received FDA approval in two other fields. In 2015, it was allowed to provide genetic testing and information for Bloom Syndrome, a rare genetic disease that increases a person’s risk for cancer, other diseases and infections, and has specific physical characteristics of short stature, high-pitched voice, prominent ears, large nose and a long narrow face, among others, according to the National Institutes of Health.

In April 2017, the company started providing customers with genetic health risk reports, giving people information about genetic variants that have signal an increased risk for certain health conditions but does not report on ones entire genetic profile.

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

Customers already in the company’s database and sequenced on their most recent platforms will have access to information concerning BRCA1 and BRCA2 in the coming weeks, 23andme said.

At particular risk for these three variants are people of Ashkenazi Jewish descent — typically from Eastern Europe — the company noted, compared with other ethnicities. About one in 40 people of Ashkenazi Jewish descent have one of the three variants and women who test positive for one of the three variants have a 45 to 85 percent chance of developing breast cancer by age 70.

“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,” Ms. 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.”

The company will also work to provide an education module to learn what the report means and how to use the results.