Oncology Community Sees Potential for Patient Harm in FDA OK of 23andMe BRCA Test

Mar 07, 2018

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NEW YORK (GenomeWeb) – Since 2013, when 23andMe had to stop marketing health-related test reports due to regulatory action from the US Food and Drug Administration, the consumer genomics firm has detected but not reported one of three specific mutations in the BRCA1 and BRCA2 genes in nearly 3,000 of its customers.

These individuals can now decide if they wish to find out their status for these BRCA1/2 mutations after 23andme this week won FDA authorization to report the test results directly to consumers (DTC).

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