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FDA Clears 23andMe BRCA1/2 Consumer Health Risk Report for 41 Additional Variants

NEW YORK – 23andMe said Thursday that the US Food and Drug Administration has granted 510(k) clearance for the company to report 41 additional variants in the BRCA1 and BRCA2 genes as part of a previously cleared genetic health risk report. The variants are linked to higher risk for breast, ovarian, prostate and pancreatic cancers.

This expands on a 2018 clearance the South San Francisco, California-based genetic testing company received to report on three BRCA1/2 mutations most commonly found in people of Ashkenazi Jewish descent. The new authorization includes variants that have greater associations with these cancers in wider populations, including those of African American, non-Ashkenazi European, and Hispanic/Latino descent.

23andMe expects to add these variants to its BRCA1/2 report by the end of its current fiscal year, which runs through March 31, 2024.

"This clearance … allows us to increase the impact and reach of our results for traditionally underserved populations, a critical long-term goal of the company," 23andMe CEO and Cofounder Anne Wojcicki said in a statement.

23andMe cautioned that variants included in the BRCA1/2 report "do not represent the majority" of BRCA variants for most ethnicities. "Results should be confirmed by an independent genetic test prescribed by your own healthcare provider before taking any medical action," the company said.

The firm also said that the FDA granted it a Predetermined Change Control Plan (PCCP) authorization, allowing the firm to add more validated BRCA1/2 variants and associated risk information to the report without the need for further premarket review. The new PCCP program is part of an April FDA guidance related to artificial intelligence and machine learning with regard to medical device software.