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What it does 

The Center for Devices and Radiological Health, under the Food and Drug Administration (FDA), has determined that 23andMe’s direct-to-consumer genetic test for selected variants of the breast cancer-associated genes BRCA1 and BRCA2 is a Class II device and is approved for immediate marketing. After review of the test, the FDA determined the test can accurately identify the specific genetic variants from a saliva sample and has reproducible results. In granting this approval, the FDA also defined a new generic category, “Cancer Predisposition Risk Assessment System for BRCA1/BRCA2 Select Variants,” for approving similar devices that may be introduced to the market in the future.

As part of its approval, the FDA established “special control” criteria to ensure safety and efficacy of the device. Broadly, the FDA is requiring measures to help the consumer understand the device, the test system, and the scope and limitations of the interpretation of the test results. Many of these controls are carried out through requirements to label the device and results with warnings and statements explaining the limitations of the device and results, and to provide hyperlinks for consumers to get more information.

Relevant Science 

BRCA1 and BRCA2 are genes that, when mutated, are associated with increased risk for developing breast, ovarian, and prostate cancer. Not all mutations in these genes are strongly associated with an increase risk for developing cancer, and genetic testing showing a mutation does not conclusively mean the individual will develop cancer.

Status 

23andMe was notified of this decision on March 6, 2018. The correspondence from the FDA grants immediate market approval of the device. A formal rule establishing the new category of medical device will be published by the FDA in the Federal Register in the coming months.

Primary Author 
Jacqueline Robinson-Hamm, PhD Candidate
Editor(s) 
Andrew Pericak, MEM
Recommended Citation 

Duke SciPol, “First Look: FDA De Novo Classification of the 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2” available at http://scipol.duke.edu/content/first-look-fda-de-novo-classification-23andme-pgs-genetic-health-risk-report-brca1brca2 (04/12/2018).

License 
Creative Commons License This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License. Please distribute widely but give credit to Duke SciPol, linking back to this page if possible.