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FDA Approves 1st Direct-to-Consumer Genetic Risk Tests
They screen for gene variants linked to 10 diseases and conditions

By Scott Roberts

THURSDAY, April 6, 2017 (HealthDay News) -- The U.S. Food and Drug Administration on Thursday approved the first direct-to-consumer genetic health risk tests.

Known as the 23andMe Personal Genome Service Genetic Health Risk tests, they assess a person's inherited risk for 10 diseases and conditions.

"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."

The tests may be used to "make decisions about lifestyle choices or to inform discussions with a health care professional," the agency said in a news release.

The tests derive DNA from a saliva sample, which is then screened for more than 500,000 genetic variants that are associated with an increased risk for the following diseases or conditions:

  • Parkinson's disease;
  • Alzheimer's disease (late onset);
  • Celiac disease;
  • Antitrypsin deficiency (Alpha-1), a disorder that raises the risk of lung and liver disease;
  • Primary dystonia (early onset), a movement disorder involving involuntary muscle contractions and other uncontrolled movements;
  • Factor XI deficiency, a blood clotting disorder;
  • Gaucher disease (type 1), an organ and tissue disorder;
  • Glucose-6-Phosphate Dehydrogenase deficiency; a red blood cell condition;
  • Hemochromatosis (hereditary), an iron overload disorder;
  • Thrombophilia (hereditary); a blood clot disorder.

The agency said it had established "special controls" to clarify its expectations of how well the tests should perform. The FDA said it also had crafted streamlined procedures to make it easier for other makers to develop and submit similar tests for approval.

The agency said in approving the tests, made by 23andMe Inc. in Mountain View, Calif., it analyzed data from peer-reviewed studies that demonstrated "a link between specific genetic variants and each of the 10 health conditions."

The FDA did warn that the tests could yield false-positive results, indicating incorrectly that a person has a certain genetic variant that would increase risk of a particular disease or condition. Test results should not be used to diagnose or treat a specific illness, the agency added.

More information

To learn more about this approval, visit the FDA.

Copyright © 2017 HealthDay. All rights reserved. URL:http://consumer.healthday.com/Article.asp?AID=721420

Resources from HONselect: HONselect is the HON's medical search engine. It retrieves scientific articles, images, conferences and web sites on the selected subject.
Risk
Blood
Alzheimer Disease
DNA
Iron Overload
Factor XI
Tissues
Muscles
The list of medical terms above are retrieved automatically from the article.

Disclaimer: The text presented on this page is not a substitute for professional medical advice. It is for your information only and may not represent your true individual medical situation. Do not hesitate to consult your healthcare provider if you have any questions or concerns. Do not use this information to diagnose or treat a health problem or disease without consulting a qualified healthcare professional.
Be advised that HealthDay articles are derived from various sources and may not reflect your own country regulations. The Health On the Net Foundation does not endorse opinions, products, or services that may appear in HealthDay articles.


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