The first authorization for genetic risk tests for disease was issued to 23andMe, the U.S. Food and Drug Administration announced Thursday.
For the first time, US regulators have authorized a company to tell consumers directly about their individual genetic risk of certain diseases and conditions without involving a health care professional. According to the FDA, genetic risk is only one piece of the overall health puzzle-it does not mean a person will or will not develop the disease.
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The FDA did warn that the tests could yield false-positive results, indicating incorrectly that a person has a certain genetic variant that would increase risk of a particular disease or condition.
In GHR tests, more than 500,000 genetic variants are searched for, which may be associated with the diseases mentioned below.
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In 2015 the FDA gave approval to 23andMe to test for mutated genes that may lead to diseases such as cystic fibrosis in children.
"Consumers can now have direct access to certain genetic risk information", said Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health. In addition, this may nudge them to make key changes in their lifestyle choices to minimize the incidence of these diseases.
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The ten approved tests include: Parkinson's (impacting movement); late-onset Alzheimer's (brain disorder); celiac disease (gluten disorder); alpha-1 antitrypsin deficiency (lung/liver disease); early onset primary dystonia (movement disorder); factor XI deficiency (blood clotting); Gaucher disease type 1 (organs and tissues); blucose-6-phosphate dehydrogenase deficiency (red blood cell condition); hereditary hemochromatosis (iron overload); and hereditary thrombophilia (blood clot disorder). It is a significant step forward for 23andMe and for the adoption of personal genetics, " Wojcicki said in the company's statement. While approving consumer use, FDA did establish criteria for expectations in tests' accuracy, reliability and clinical relevance. Days after the FDA sent a warning letter, the company was sued for "falsely and misleadingly" advertising their tests could provide information on more than 240 conditions and traits.