Friday, 20 October, 2017

FDA OKs 1st At-Home Genetic Tests for 10 Disorders

Helix DNA 6 To use 23and Me and other consumer DNA tests you need to submit a spit sample. Hollis Johnson
Tracy Craig | 08 April, 2017, 07:46

Risks associated with the 23andMe genetic tests include false-positive findings - meaning they wrongly indicate a key genetic variant in the test taker.

The US Food and Drug Administration will allow the genetic testing company 23andMe to market tests for 10 serious disease and conditions, in a move that marks an about-face on the 2013 moratorium imposed on it. Then the FDA required the company to withdraw all its tests for genetic risks related to health from the market because the company had not established the efficacy of its tests and had gone silent on regulators.

The tests are meant to be used to "make decisions about lifestyle choices or to inform discussions with a health care professional", the FDA stated in a news release.

The test can not give a full picture of a person's overall risk for diseases, because it does not account for environmental or lifestyle factors as well as every single genetic variant.

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The FDA said it does not plan exemptions for genetic health risk tests that function as diagnostic tests, which might be used for major treatment decisions. These include Alzheimer's, Parkinson's, celiac and several blood diseases. While the GHR tests may provide genetic risk information, they can not determine a person's overall risk for developing a disease, as other factors beyond genetics (ie, environment, lifestyle) may also influence risk.

Being predisposed to a disease isn't the same as a diagnosis, raising concerns that without an expert intervening individuals could still read too much into the results, causing distress or confusion.

Genetic screening is a double edged sword, one the FDA has been explicitly critical of in the past in its warning 23andMe to hold off on marketing their Personal Genome Service until it received the right clearance.

The 10 conditions are all heavily determined by DNA variants - and the company has demonstrated the ability to relay the risk factors in consumer-friendly ways that have been backed by peer-reviewed science, the federal agency announced. The tests will be marketed as part of the US$199 Health and Ancestry test that the company already provides.

Being able to mail off a vial of saliva and get back information relevant to your health and your future family could help weigh the risks behind certain decisions more accurately.

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