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# More Variants Cleared for 23andMe Genetic Test
- URL: https://www.fdaweb.com/more-variants-cleared-for-23andme-genetic-test/
- Published: 2023-09-01T12:00:00.000Z
- Updated: 2026-09-14T18:54:08.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5155236

FDA has cleared a 23andMe 510(k) to expand its existing BRCA1/BRCA2 (Selected Variants) Genetic Health Risk Report by allowing it to report an additional 41 variants known to be associated with higher risk for breast, ovarian, prostate and pancreatic cancer. “23andMe received the first FDA authorization for a direct-to-consumer genetic test for cancer risk in 2018 to report 3 variants in the BRCA1 and BRCA2 genes, primarily found in people of Ashkenazi Jewish descent,” the company says. “Many of the 41 BRCA variants added through this clearance are known to have a higher rate of occurrence in populations traditionally underserved by genetic testing, including the African American and Hispanic/Latino communities.”

In addition to the 510(k) clearance, FDA also granted 23andMe a “Predetermined Change Control Plan (PCCP), which allows the Company to add additional validated BRCA1 and BRCA2 variants and associated cancer risk information to its report without additional premarket review. “The PCCP outlined the specific protocols and acceptance criteria that 23andMe intends to use to clinically and analytically validate eligible BRCA1/BRCA2 variants,” the company says.