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

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.”

Do you have additional questions about genetic testing for Parkinson’s? The Parkinson’s Foundation invites the community to contact our HelpLine to ask further questions to learn more by contacting 1 (800) 4PD-INFO (473-4636) or helpline@parkinson.org or (800) 457-6676 or info@pdf.org or by using our free resource below.

Learn More: Genetics and PD: What’s New?

About the Parkinson's Foundation

The Parkinson's Foundation is working toward a world without Parkinson's disease. Formed by the merger of National Parkinson Foundation (NPF) and the Parkinson's Disease Foundation (PDF) in August 2016, the mission of the Parkinson's Foundation is to invest in promising scientific research that will end Parkinson's disease and improve the lives of people with Parkinson's, and their families, through improved treatments, support and the best care. For more information, visit www.parkinson.org or www.pdf.org, or call (800) 4PD-INFO (473-4636) or (800) 457-6676.                 

About Parkinson's Disease (PD)

Affecting an estimated one million Americans and ten million worldwide, PD is the second most common neurodegenerative disease after Alzheimer's and is the 14th leading cause of death in the United States. It is associated with a progressive loss of motor control (e.g., shaking or tremor at rest and lack of facial expression) as well as non-motor symptoms (e.g., depression and anxiety). There is no cure for PD and 60,000 new cases are diagnosed each year in the United States alone.