Updated Health Risk Report for BRCA1/BRCA2 Cleared by the US FDA

An updated direct-to-consumer (DTC) test that reports selected BRCA1/BRCA2 genetic variants was updated to add 41 BRCA1/BRCA2 variants to the previously authorized test. 

This DTC test analyzes DNA from a self-collected saliva sample.

It generates personalized reports describing if the genetic variants detected in that sample are associated with an increased risk of developing breast and ovarian cancer and may be associated with an increased risk for prostate, pancreatic, and potentially other cancers.

On September 1, 2023, the U.S. Food and Drug Administration announced it cleared for marketing the updated 23andMe Personal Genome Service Genetic Health Risk Report for BRCA1/BRCA2.

These reports provide genetic information to inform discussions with a healthcare professional.

Consumers and healthcare providers should not use the test results to substitute for healthcare visits for recommended cancer screenings or appropriate follow-up; results from this test should not be used to determine any treatments. 

This report does not represent most of the BRCA1/BRCA2 variants in people of most ethnicities. This means a negative result does not rule out the presence of other variants that increase cancer risk, says the FDA.