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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 or (800) 457-6676 or 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 or call (800) 4PD-INFO (473-4636).

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 A feeling of nervousness, worried thoughts and physical distress.). There is no cure for PD and 60,000 new cases are diagnosed each year in the United States alone.

Thursday, April 6, 2017
Parkinson’s Foundation Adds John D. Thomopoulos to its Board of Directors
Monday, March 19, 2018

MIAMI & NEW YORK – March 19, 2018 – The Parkinson’s Foundation today announced the election of John D. Thomopoulos to its board of directors. Thomopoulos is a partner at Ernst & Young.

In Memory of Edythe Kay Marsa
Monday, March 12, 2018

The Parkinson’s Foundation mourns the loss of emeritus board member, Edythe (Edy) Kay Marsa. From 1993 to 2014, she was a member of the Foundation’s board of directors and served on several committees. Edy is survived by her husband William Marsa, who founded the Herbert Kay Parkinson Chapter in honor of her first husband who passed away due to complications from Parkinson’s disease.

Parkinson’s Foundation Announces New Genetic Initiative Connecting Parkinson’s Genetic Data with Clinical Care
Tuesday, March 6, 2018

MIAMI & NEW YORK—March 6, 2018—The Parkinson’s Foundation today announced a new initiative offering genetic testing and counseling to Parkinson’s patients within its Center of Excellence network.

Delegates From The Parkinson’s Community Converge On Capitol Hill To Advocate For Critical Research Funding
Monday, March 5, 2018

—2018 Parkinson’s Policy Forum Co-Sponsored by the Parkinson’s Foundation and the Michael J. Fox Foundation for Parkinson’s Research—

Parkinson’s Foundation Appoints Jena E. Abernathy to Board of Directors
Tuesday, February 27, 2018

MIAMI – February 27, 2018 –  The Parkinson’s Foundation today announced the election of Jena E. Abernathy to its board of directors.

Parkinson’s Foundation Moving Day Walks Fund Local Parkinson’s Programs in Seven Cities for Spring 2018
Friday, February 16, 2018

NEW YORK & MIAMI, FEBRUARY 16, 2018 — The Parkinson’s Foundation is proud to announce that Moving Day, A Walk for Parkinson’s, has funded more than $17 million in mission services to make life better for people living with Parkinson’s disease (PD).

Terranova’s Stephen Bittel Donates $450,000 to Parkinson’s Foundation to Support Expansion of Centers of Excellence Network
Thursday, February 1, 2018

MIAMI – February 1, 2018 – The Parkinson’s Foundation today announced that Stephen Bittel, chairman and founder of Terranova, has made a $450,000 donation to support the expansion of the foundation’s Centers o

Largest Clinical Study of Parkinson’s Disease Reaches 10,000-Patient Milestone, Reveals Critical Learnings
Wednesday, January 10, 2018

NEW YORK & MIAMI - January 10, 2018 - The Parkinson’s Foundation today announced the enrollment of the 10,000th Parkinson’s patient and the discovery of critical new learnings in what represents the largest clinical study of Parkinson’s disease in history.

Parkinson's Foundation Mourns the Loss of Harold P. Kravitz and His Daughter, the Honorable Shelley J. Kravitz
Friday, January 5, 2018

Today we mourn the loss of two prominent figures in the history of the Parkinson's Foundation: Harold P. Kravitz, Esq. and his daughter, the Honorable Shelley J. Kravitz.

Parkinson's Foundation Mourns the Loss of Robert Burke, MD
Friday, January 5, 2018

The Parkinson’s Foundation mourns the loss of Robert Burke, MD, professor of Neurology at Columbia University, a Parkinson’s Foundation Center of Excellence. He was a former member of the Parkinson’s Disease Foundation (PDF) Scientific Advisory Board and led the PDF Research Center at Columbia.


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