USA – 23andMe, a genetic testing company, has announced that its prostate cancer risk test has been approved by the Food and Drug Administration.
It’s 23andMe’s third cancer risk report approval; the company also has tests for genes that predict breast and colorectal cancer risk.
The test looks for a specific mutation on the HOXB13 gene that has been linked to an increased risk of prostate cancer.
According to one study, men with the G84E variant have a threefold increased risk of developing prostate cancer than men without the mutation.
According to 23andMe, the variant affects about one in every 70 people of European descent.
According to the company, the prostate cancer risk report is not yet available to 23andMe customers. Customers will be able to opt-in or opt-out of seeing their results.
Those who choose to watch it will also have access to an “educational module” that will teach them how to interpret the results.
In 2018, 23andMe received its first FDA approval for a cancer risk screening test, when the agency approved its tests for three BRCA1 and BRCA2 gene mutations.
The mutations are linked to an increased risk of prostate cancer, ovarian cancer, and breast cancer.
However, those specific mutations are not the most common mutations linked to those cancers in the general population; rather, they are most common among people of Ashkenazi Jewish ancestry.
They can provide some information to 23andMe customers, but they cannot rule out other mutations linked to those cancers.
The FDA approved the company’s test for genetic variants linked to a hereditary colorectal cancer syndrome in early 2019. This type of cancer accounts for only about 5% of all colorectal cancers.
Prostate cancer is one of the most common types of cancer in men in the United States. According to the CDC, 13 out of every 100 men will develop prostate cancer during their lives, and two to three men will die as a result of the disease.
Although age is the most common risk factor for prostate cancer, African American men and those with a family history of the disease are also at increased risk. People of Northern European ancestry are more likely to have the G84E mutation.
Last year, the direct-to-consumer genetics testing company went public via a merger with a special purpose acquisition company, a popular method of public exit for digital health startups.
In October, 23andMe announced the acquisition of Lemonaid Health, a telehealth and online prescription platform.
The deal, which closed not long after it was announced, was marketed as a move into primary care, with genetic testing used to provide preventive care.
Other genetic testing companies include Invitae, which announced plans last year to scoop up digital health record company Ciitizen, and Ancestry, which received two FDA 510(k)s of its own in August 2020.