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FDA Cleared First DTC Genetic Tests for Health Risks

17 April 2017

Medical Device Alert
Last week, the U.S. Food and Drug Administration (FDA) granted marketing authorization for 23andMe’s Personal Genome Service (PGS) Test for 10 diseases or conditions. This was the first FDA authorization for a direct-to-consumer (DTC) genetic test that provides information on personal risk for certain diseases.

The 23andMe PGS Test uses qualitative genotyping to detect the clinically relevant variants in genomic DNA isolated from human saliva collected from individuals over 18 years for the purpose of reporting and interpreting Genetic Health Risks (GHR). Specifically, the test is intended to detect genetic variants that are associated with an increased risk for developing 10 diseases or conditions.

Read more: FDA Cleared First DTC Genetic Tests for Health Risks.


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