(Bloomberg) — DNA testing company 23andMe Inc. said it has gotten the green light from the U.S. Food and Drug Administration to offer consumers a test for a hereditary colorectal cancer syndrome.
23andMe said it will now be able to tell customers whether they have two genetic variants that influence MUTYH-associated polyposis, a rare condition associated with an increased risk of colorectal cancer. The FDA didn’t immediately respond to a request for comment.
Key Insights
It’s the second test associated with cancer risk for which 23andMe has received FDA clearance. Last March, the Mountain View, California-based firm began offering a report on three genetic variants associated with increased risk of breast cancer in the BRCA1 and BRCA2 genes. The BRCA tests were controversial. Though there are more than 1,000 known BRCA mutations, the 23andMe test focused on three variants most common in people of Ashkenazi Jewish descent. The concern was that people not likely at risk for those variants — those not of Ashkenazi descent, for example — would mistake not having the mutations as not having any risk of breast cancer. There is also broad concern about such tests being offered to consumers directly, without the insight of a doctor or genetic counselor to help interpret results and plan any medical care accordingly.
Know More
Hereditary colorectal cancers account for a minority of colorectal cancer cases, only about 5 percent, according to 23andMe. The new tests don’t look at variants associated with Lynch syndrome, the most common form of inherited colorectal cancer. Originally, 23andMe offered assessments for more than 250 diseases and conditions, but in 2013 the FDA cracked down and ordered the company to cease providing analyses of people’s risk factors until the tests’ accuracy could be validated.
- Donald Trump Was Just Indicted. Here's What to Know About the Charges and the Case
- What Could Happen Next for Donald Trump
- Trump's Indictment Drama Showcased His Rivals' Weakness
- Inside Ukraine's Push to Try Putin For War Crimes
- Bad Bunny's Next Move
- Elon Musk Signs Open Letter Urging AI Labs to Pump the Brakes
- Eliezer Yudkowsky: Pausing AI Developments Isn't Enough. We Need to Shut it All Down
- 'How Is This Still Happening?' A Survivor Questions America's Gun Violence Problem
- Cheryl Strayed Will Always Be Here for You
- Who Should Be on the 2023 TIME100? Vote Now