Direct-to-Consumer Genetic Test for Select BRCA Mutations Gets FDA Nod
The Personal Genome Service Genetic Health Risk Report is designed to test for particular BRCA1/2 variants.
The US Food and Drug Administration (FDA) approved a direct-to-consumer test for 3 BRCA mutations, according to a press release.1 The covered mutations are, however, the most common only among individuals of Ashkenazi Jewish descent, rather than the general population.
The approval is for the Personal Genome Service Genetic Health Risk (GHR) Report, which tests for particular variants of BRCA1/2, and may help to determine a woman's risk of breast and ovarian cancer and a man's risk of prostate cancer. The GHR report analyzes data from an individual's saliva sample.
As the report covers only 3 of 1000 known BRCA variants, a negative result does not mean an individual is at a lower cancer risk.
While these variants are found in about 2% of Ashkenazi women, they are present in up to only 0.1% of individuals in other ethnic groups.
The press release notes, furthermore, that consumers and health care professionals should not use this test's results to determine any treatments.
The GHR report was developed by 23andMe. More information can be found here.
FDA authorizes, with special controls, direct-to-consumer test that reports three mutations in the BRCA breast cancer genes [news release]. Silver Spring, MD: US Food and Drug Administration; March 6, 2018. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm599560.htm?utm_campaign=03062018_PR_23andme_BRCA. Accessed March 7, 2018.