THE US Food and Drug Administration (FDA) has allowed marketing of 23andMe Personal Genome Service Genetic Health Risk (GHR) tests for 10 conditions.
These are the first direct-to-consumer (DTC) tests authorized by the FDA that provide information on an individual's genetic medical predispositions.
The 23andMe GHR tests work by isolating DNA from a saliva sample, which is then tested for more than 500,000 genetic variants which indicate an increased risk for developing a variety of diseases, including Parkinson's disease, late-onset Alzheimer's disease, coeliac disease, alpha-1 antitrypsin deficiency, early-onset primary dystonia, Factor XI deficiency, Gaucher disease type 1, glucose-6-phosphate dehydrogenase deficiency (G6PD), hereditary haemochromatosis and hereditary thrombophilia.
The results can influence lifestyle choices and inform discussions with health professionals, the FDA said.
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