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US FDA Greenlights First Direct-To-Consumer Cancer-Risk Test

23andMe gained FDA go-ahead for the first direct-to-consumer genetic test for cancer risk, as the firm continues to map out regulatory frameworks for the DTC gene-screening space with its third de novo authorization in three years.

For the first time, American consumers will be able to use a direct-to-consumer genomic test vetted by US FDA that gives them information about cancer risk. The population anticipated to benefit is small, but the marketing authorization for 23andMe to add select variants of the BRCA1/BRCA2 gene mutations Personal Genome Service Genetic Health Risk (GHR) Report represents the next step in the firm's efforts to establish a regulatory foundation for DTC genetic tests.

The is the company's third de novo classification since 2015, each establishing a pathway for different categories of DTC tests,...

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