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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 helpline@parkinson.org or (800) 457-6676 or info@pdf.org or by using our free resource below.

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 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 Hosts National Forum for Women Living with Parkinson's Disease
Wednesday, November 7, 2018

MIAMI & NEW YORK — NOVEMBER 7, 2018 —The Parkinson’s Foundation hosted the first national forum for women with Parkinson’s disease (PD) on October 19 at Baylor College of Medicine, a Parkinson’s Foundation Center of Excellence, in Houston, TX.

Parkinson's Foundation Announces Expansion of Community Grants Program to Address Unmet Community Needs
Thursday, November 1, 2018

The Parkinson’s Foundation is requesting applications for community grants to be awarded nationwide for health, wellness and education programs that address unmet needs in the PD community. The Foundation will award $1.2 million in community grants in 2019.

Parkinson’s Foundation Announces Expansion of Community Grants Program to Address Unmet Community Needs
Thursday, November 1, 2018

NEW YORK & MIAMI — November 1, 2018 — The Parkinson’s Foundation is proud to announce that it is requesting applications for community grants to be awarded nationwide for health, wellness and education programs that address unmet needs in the Parkinson’s disease (PD) community. In 2019, the Parkinson’s Foundation will award $1.2 million in community grants.

Parkinson’s Foundation Hosts Free Bilingual Caregiver Summit
Tuesday, October 30, 2018

MIAMI AND NEW YORK—October 30, 2018—The Parkinson’s Foundation will host a Caregiver Summit – “Cumbre Para Cuidadores” – geared specifically toward caregivers of people living with Parkinson’s disease (PD).

Parkinson’s Foundation Adds James Monhart to its Board of Directors
Monday, October 29, 2018

NEW YORK & MIAMI, October 29, 2018—The Parkinson’s Foundation today announced the election of James F.T. Monhart to its board of directors.

Parkinson’s Foundation Earns 4-Star Rating from Charity Navigator
Monday, October 22, 2018

NEW YORK AND MIAMI—October 22, 2018—The Parkinson’s Foundation has achieved a 4-star rating from Charity Navigator, the nation's largest and most-utilized evaluator of charities.

The 4-star rating is the highest rating given only to nonprofit organizations that exceed industry standards and outperform peers, while demonstrating strong financial health and commitment to accountability and transparency.

Parkinson’s Foundation Awards New Nurse Faculty Grant to Four Nurses Specializing in Parkinson’s Care
Thursday, October 11, 2018

NEW YORK & MIAMI — October 11, 2018 — The Parkinson’s Foundation announced that it has awarded its first-ever Parkinson’s Foundation Nurse Faculty Award to four nurses, totaling $30,000. The nurses, all graduates of the Edmond J.

Update on NUPLAZID — FDA finds no new or unexpected safety risks
Friday, September 21, 2018

On September 20, 2018, the U.S.

Parkinson’s Foundation Extends Bilingual National Helpline Hours
Tuesday, September 18, 2018

NEW YORK & MIAMI — September 18, 2018 — The Parkinson’s Foundation announced today that its toll-free Helpline, 1-800-4PD-INFO, will extend its hours, answering calls in English and Spanish, to help make life better for people with Parkinson’s disease (PD) and their families.

Parkinson’s Foundation Hosts Allied Team Training for Parkinson’s in Atlanta
Tuesday, September 11, 2018

NEW YORK & MIAMI—September 11, 2018—The Parkinson’s Foundation today announced the location of its signature professional education program course, Allied Team Training for Parkinson’s, ATTP®, for health care professionals treating patients with Parkinson’s disease, in Atlanta.

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