23andMe wins FDA clearance to test for expanded set of BRCA cancer risk variants

MedTech Dive September 5, 2023
Nick Paul Taylor

The new version of the test can report more cancer-related gene mutations, and 23andMe can add variants in the future under an agreement with the FDA.

Dive Brief:

• The U.S. Food and Drug Administration cleared 23andMe on Thursday to report another 41 BRCA1 and BRCA2 gene variants in its cancer risk test.
• 23andMe received clearance for the original test in 2018, but that product only tested for three mutations. A competitor, Invitae, recently warned testing for the three mutations misses more than 90% of pathogenic or likely pathogenic variants in the general population.
• The expanded clearance helps address that criticism. In announcing the development, 23andMe highlighted the prevalence of the newly added variants in African American and Hispanic/Latino communities,...

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