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ARTICLE | Clinical News

FDA approves 23andMe's direct-to-consumer test for cancer risk

March 9, 2018 6:59 PM UTC

23andMe Inc. (Mountain View, Calif.) said FDA authorized its direct-to-consumer BRCA1/BRCA2 (Selected Variants) Genetic Health Risk (GHR) Report to provide patients with genetic information on their cancer risk. The approval, which came via FDA's de novo premarket review pathway, opens up a new regulatory classification under the 510(k) pathway for future devices of the same type, with the genetic test serving as a predicate device.

The GHR test provides customers, without a prescription, information on three breast cancer 1 early onset (BRCA1) and BRCA2 variants associated with higher risk for breast, ovarian and prostate cancer: the 185delAG and 5382insC variants of the BRCA1 gene and the 6174delT variant of the BRCA2 gene...

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