Call Our HELPLINE: 1-800-4PD-INFO (473-4636)

FDA Allows Marketing of a Genetic Test for Medical Conditions Including Parkinson’s

Earlier today, the US Food and Drug Administration (FDA) announced that it will allow direct marketing to consumers of a genetic test that identifies predispositions for 10 medical conditions, including Parkinson’s. Such tests are referred to as direct-to-consumer or DTC.

Unlike genetic tests used in medical settings, DTC tests are sold directly to the public. They offer information on genetic risk factors, but without the guidance and counseling that is typically recommended by a medical center. This is the first time the FDA has allowed a company to market a DTC test that provides information on disease risk.

A very small percentage of people with Parkinson’s inherit the disease because of genetic changes. Many others have genetic variations that increase their risk, but do not actually cause the disease. The Parkinson’s Foundation offers advice to individuals considering genetic tests:

"Direct-to-consumer genetic testing can help to identify who is at risk for developing Parkinson's but cannot predict who will be diagnosed," said John L. Lehr, CEO, Parkinson’s Foundation. "The Parkinson’s Foundation recommends that people who are interested in testing first seek guidance from their doctors and from genetic counselors to understand what the process may mean for them and their families."

Thursday, April 6, 2017
mail icon

Subscribe to get the latest news on treatments, research and other updates.