Known as the 23andMe Personal Genome Service Genetic Health Risk tests, they assess a person's inherited risk for 10 diseases and conditions. Consumers' DNA is extracted from a saliva sample.
The company said it has been working on showing the FDA that the reports are easy for customers to understand and that they meet the agency's requirements proving that they are accurate. The presence or absence of some of these variants is linked to an elevated risk for developing any one of the following diseases or conditions: Parkinson disease, late-onset Alzheimer disease, celiac disease, alpha-1 antitrypsin deficiency, early-onset primary dystonia, factor XI deficiency, Gaucher disease type 1, glucose-6-phosphate dehydrogenase deficiency, hereditary hemochromatosis, and hereditary thrombophilia. Your results are delivered online.
23andMe will now be reporting telltale markers for 10 diseases. The company then looks at your DNA for 500,000 genetic variants.
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Sharon Terry, the CEO of the Genetic Alliance, a nonprofit organization that advocates for health care for people with genetic disorders, likens it to another consumer test. "Women learn they are pregnant using a test directly marketed to them and buy it off the shelf in a drugstore", she told NPR. Saliva analysis can indicate higher risk of Parkinson's disease, among others, agency says.
At the time, the company had been providing customers with assessments for more than 250 diseases, along with health advice that the FDA determined was a little premature given the limited state of the scientific evidence and risked being misinterpreted without a doctor's assistance. The decision is expected to open the floodgates for more direct-to-consumer tests for disease risks, drawing a road map for other companies to do the same thing. A person may have genes that are associated with Alzheimer's, for example, but that doesn't mean he or she will ever get the disease.
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