Upcoming Webinars Archived Webinars Training Vitals Host A Webinar About Get Updates Contact

23andMe DTC Genetic Health Risk Reports Approved by FDA



The FDA has granted marketing approval to personal genetics company, 23andMe, for their direct-to-consumer (DTC) Genetic Health Risk (GHR) tests.

Share this!

April 10, 2017 | by Sarah Hand, M.Sc.

The FDA has granted marketing approval to personal genetics company, 23andMe, for their direct-to-consumer (DTC) Genetic Health Risk (GHR) tests. The tests – which provide individuals with their genetic risk of developing 10 different diseases and conditions – are the first FDA-approved tests of their kind on the market.

According to the FDA, the GHR tests may help individuals make informed decisions about lifestyle factors, as well as drive meaningful conversations with their doctors. However, the real challenge comes in ensuring consumers understand the implications of being genetically predisposed to a disease, and that it doesn’t guarantee that a person will develop the condition in the future.

“Consumers can now have direct access to certain genetic risk information,” said Dr. Jeffrey Shuren, 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.”

Conditions included in the GHR test, which analyzes over 500,000 genetic variants, are: Alzheimer’s disease, celiac disease, Parkinson’s disease and hereditary thrombophilia, and others. The reports are set to launch this month, and 23andMe says they plan on releasing further tests in the future.

“This is an important moment for people who want to know their genetic health risks and be more proactive about their health,” said Anne Wojcicki, 23andMe CEO and co-founder. “The FDA has embraced innovation and has empowered individuals by authorizing direct access to this information. It is a significant step forward for 23andMe and for the adoption of personal genetics.”

The GHR reports were approved through the FDA’s de novo classification pathway for first-of-a-kind medical devices. 23andMe has also received pre-market review exemptions from the FDA for any additional GHR tests they develop.

The approval was based upon the availability of scientific literature providing demonstrated links between the genetic variants tested and the 10 health conditions included in the GHR panel. The GHR tests themselves were shown to consistently provide accurate results on genetic disease risk from patient saliva samples.

The FDA does warn that like all diagnostic tests, the 23andMe GHR tests can return false-positive or false-negative results. Because of this, the regulator says that the GHR tests should not be used for disease diagnosis, nor should they be considered sufficient evidence to start treatment for a specific disease or condition.

Keywords:  Genetic Test, FDA, Hereditory Disease


Share this with your colleagues!

Exclusion Criteria for Clinical Trials Poses Major Barrier to Patient Enrollment

August 17, 2017 - UT Southwestern researchers say that clinical investigators continue to increase the number of exclusion criteria, preventing more patients from participating in clinical trials.

Featured In: Clinical Trials News

Targeting Cellular Nitrogen Metabolism Could Offer a New Treatment for Pancreatic Cancer

August 17, 2017 - An enzyme involved in regulating the amount of nitrogen in the cell could be a new drug target for pancreatic cancer, according to researchers from Boston Children's Hospital and the Broad Institute of MIT and Harvard.

Featured In: Life Science News

Regeneron’s Drug for Respiratory Syncytial Virus Fails in Phase III Clinical Trial

August 16, 2017 - Biotechnology company Regeneron has announced it will not continue development of its antibody drug, suptavumab, after a failure in a Phase III clinical trial.

Featured In: Clinical Trials News


One Patient’s Perspective on Clinical Trials


Planning and Conducting Trials of the Latest Immunotherapies

ISO 13485:2016 for Medical Device Manufacturers: Ensuring a Smooth Transition through Effective Preparation

Medical Devices: Reviewing Regulatory Changes in the US and EU

Moving Beyond Regulatory and Performance Metrics in Starting Clinical Trials

Copyright © 2016-2017 Honeycomb Worldwide Inc.