23andMe gets FDA approval for at-home breast cancer risk test

(CNN) — Genetic testing company 23andMe has been given federal approval to sell at-home kits that test for three breast cancer gene mutations.

This will be the first direct-to-consumer DNA test for these particular breast cancer gene mutations, the Food and Drug Administration said on Tuesday.

A spokeswoman for 23andMe said the test for the three BRCA1/BRCA2 breast cancer gene mutations will be added “in the coming weeks” to the broader Health + Ancestry services, with no increase to the existing $199 cost.

The test can only detect three out of more than 1,000 known BRCA mutations, according to the FDA. The BRCA1/BRCA2 hereditary mutations occur in about 2% of Ashkenazi Jewish women, but rarely occur in anyone else, the agency said in a press release.

Related Content: Ultra-processed foods linked to increased cancer risk

“The test also does not provide information on a person’s overall risk of developing any type of cancer,” the FDA added.

23sandMe already tests for genetic health risks for diseases like Parkinson’s and Alzheimer’s, along with wellness reports for things like lactose intolerance and saturated fat, and ancestral composition including Neanderthal ancestry.

In 2013, the FDA ordered the company to stop sales of its home-testing kits, saying the Alphabet-backed company had failed to prove the validity of its product.

Anne Wojcicki, who founded the company in 2006, called the FDA shutdown a “transformative moment” that prompted 23andMe to branch into drug development.

“Thank you to the FDA for hard work and progress on innovation,” she tweeted on Tuesday.

In 2015, 23andMe received approval from the FDA to test customers for whether they are carriers of certain disease-carrying genes that could be passed on to their children. In early 2017, the company received approval to issue genetic health risk reports.

In September of last year, the company said it received $250 million in funding from Sequoia Capital to develop drugs based on user DNA.

WTNH NEWS8 provides commenting to allow for constructive discussion on the stories we cover. In order to comment here, you acknowledge you have read and agreed to our Terms of Service. Commenters who violate these terms, including use of vulgar language or racial slurs, will be banned. Please be respectful of the opinions of others. If you see an inappropriate comment, please flag it for our moderators to review. Also, you can now block any inappropriate user by simple selecting the drop down menu on the right of any comment and selection "Block User" from there.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s