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FDA Allows Marketing of First Direct-to-Consumer Tests that Provide Genetic Risk Information for Certain Conditions
Posted 7 Apr 2017 by Drugs.com
April 6, 2017 – The U.S. Food and Drug Administration today allowed marketing of 23andMe Personal Genome Service Genetic Health Risk (GHR) tests for 10 diseases or conditions. These are the first direct-to-consumer (DTC) tests authorized by the FDA that provide information on an individual’s genetic predisposition to certain medical diseases or conditions, which may help to make decisions about lifestyle choices or to inform discussions with a health care professional. “Consumers can now have direct access to certain genetic risk information,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “But it is important that people understand that genetic risk is just one piece of the bigger puzzle, it does not mean they will or won’t ultimately develop a disease.” The GHR tests are intended to provide genetic risk information to consumers, but the ... Read more
Posted 1 Apr 2011 by Drugs.com
THURSDAY, March 31 – For people with the movement disorder dystonia, starting deep brain stimulation therapy early in the course of the disease provides better results, according to a new study. Dystonia is a potentially crippling disorder that causes muscles to contract, resulting in involuntary twisting of affected areas of the body. Deep brain stimulation is approved in the United States for certain treatment-resistant dystonias. The study included 44 patients, aged 10 to 59 years, with generalized dystonia who received a deep brain stimulation device, which consists of electrical leads implanted in the brain and an electrical pulse generator placed near the collarbone. The device controls abnormal nerve signals that cause uncontrolled muscle contractions in people with the disorder. After receiving the device, all of the patients experienced overall improvement in their ability to ... Read more
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