23andMe Just Received FDA Green Light for Cancer Test
At-home DNA test kits have become increasingly popular over the last couple of years, with family and friends now gifting each other the option to get their DNA tested to discover their ancestry and analyze their health. Now, in a first-ever move by the U.S. Food and Drug Administration (FDA), 23andMe—one of the most popular at-home DNA testing kits—has received FDA approval to test its customers for hereditary colorectal cancer syndrome.
While 23andMe previously received clearance in March 2018 from the FDA to test for BRCA1/BRCA2 (Selected Variants) to notify customers if they were at an increased risk for breast cancer, this is the first authorization the FDA has issued on testing for hereditary colorectal cancer syndrome.
Customers who opt in for this new test will be screened for two genetic variants that can influence a rare condition (MUTYH-associated polyposis) associated with an increased colorectal cancer risk—and they must opt in.
“As with the BRCA1/BRCA2 report, 23andMe Health + Ancestry Service customers must choose whether or not they want to receive this information,” the 23andMe team says. “Like with other 23andMe Genetic Health Risk reports, this one will also include an education module to ensure customers are informed on what they can learn from this report and how to interpret the results, as well as its limitations.”
Such education will include notifying customers that hereditary colorectal cancers make up only approximately five percent of total cases of colorectal cancer; customers will also be notified that this test does not screen for the most common hereditary colorectal cancer, Lynch syndrome.
“We are committed to giving people affordable and direct access to important health information that can impact their lives,” said Anne Wojcicki, 23andMe CEO and co-founder. “We believe improved access to genetic testing and health information will help people engage in their own health.”
But can you trust the results? “For this newest clearance, the MUTYH-Associated Polyposis Genetic Health Risk report adhered to the same standards used in our other reports,” the 23andMe team assures consumers, “including greater than 99 percent accuracy and utilization of key informational concepts that achieved 90 percent or greater comprehension in a demographically diverse population.”
As consumers demand greater autonomy over their own health, 23andMe is answering their calls, one at-home DNA test kit at a time.
Want to learn more about companies making waves? Discover how this brand is disrupting the status quo with innovation and higher safety standards.