FDA approves 23andMe test to evaluate cancer risk

FDA approves 23andMe test to evaluate cancer risk

However, the test is limited in that it can only assess 3 mutations of breast cancer, most often only found in individuals of Ashkenazi (Eastern European) Jewish descent. "This means a negative result does not rule out the possibility that an individual carries other BRCA mutations that increase cancer risk".

In a reversal of fortune for 23andMe, the US Food and Drug Administration (FDA) has granted the company the first-ever authorization for direct-to-consumer genetic testing for cancer risk without a prescription.

The three hereditary mutations detected by the test occur in about 2% of Ashkenazi Jewish women but are far more rare in the general population (0-0.1%).

More news: Amazon's Alexa is randomnly laughing at users

The three variants in the BRCA1 and BRCA2 genes are associated with a significantly higher risk of breast and ovarian cancer in women, and breast cancer in men.

Donald St. Pierre of the FDA's Office of In Vitro Diagnostics and Radiological Health said in a statement announcing the approval that the test is intended for people who might not otherwise get genetic testing, adding that "it has a lot of caveats". Furthermore, only a small percentage of Americans carry one of these 3 mutations.

And the FDA said no doctor or patient should use the test as a basis for deciding treatment, "including anti-hormone therapies and prophylactic removal of the breasts or ovaries". It is important to note that the test only detects 3 out of the more than 1,000 known breast cancer mutations.

More news: Far Cry 5's Map Editor Sounds Totally Wild

The FDA today granted authorization for a direct-to-consumer test for a highly selected group of cancer-associated BRCA mutations.

The agency stressed that this test should not be used as a replacement for a visit to the doctor for cancer screenings or counseling on genetic and lifestyle factors that can increase or decrease cancer risk. The agency also outlined special controls created to assure test's accuracy and reliability.

Topol's warning reflects an FDA letter sent to the service back in 2013, urging 23andMe to discontinue marketing its Saliva Collection Kit and Personal Genome Service.

More news: Ex-Trump aide plans to defy Mueller, says 'arrest me'

Related Articles