FDA Approves Genetic Test for Personal Disease Risk

FDA Approves Genetic Test for Personal Disease Risk

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.

"Consumers can now have direct access to certain genetic risk information", Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said Thursday in an agency news release. The test is able to provide risk information for the following health conditions: Parkinson's disease, late-onset Alzheimer's disease, celiac disease, alpha-1 antitrypsin deficiency, early-onset primary dystonia, Factor XI deficiency, Gaucher disease type 1, glucose-6-phosphate dehydrogenase deficiency, hereditary hemochromatosis, and hereditary thrombophilia.

Google, Amazon eye Toshiba's chip unit
The latest bit comes amidst the specter of the company having its shares delisted from the Tokyo Stock Exchange. Toshiba shareholders on Thursday agreed to split off its prized chip unit, paving the way for the sale.

Hoping to streamline approvals, the FDA plans to exempt additional 23andMe genetic health risk tests from its pre-market review. But it cautioned that genetic risk is just one piece of information and does not mean they will or won't eventually get a disease.

Genetic testing can be useful to find out certain disease and conditions you may be at risk of developing. 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 stressed that the product labeling should indicate that the test is not created to diagnose, determine treatment, or suggest anything about a user's state of health, the WSJ reported.

Autopsy 'shows chemical weapons used in Syria attack'
Russia's ambassador at the United Nations dismissed the U.S. -British-French resolution as "hasty". The Britain-based Syrian Observatory for Human Rights monitoring group put the toll at 86 killed.

To use the genetic test service of 23andMe, a person only has to spit into a tube and send it to the company where the lab will work on extracting DNA from the saliva cells and look for genetic markers using a special chip.

In November 2013, the FDA blocked 23andMe from marketing its GHRs, citing a false positive result could lead to unnecessary treatments, while a false negative could lead a patient to improperly treat an actual risk that may exist.

Flyers' Neuvirth carted off ice after collapsing in crease
As the teams prepared for a faceoff at center ice during the first period, Flyers goalie Michal Neuvirth collapsed in his crease. Shortly before the NHL All-Star break, the Flyers earned a 3-0 shutout win at Madison Square Garden on January 25.

The U.S. National Human Genome Research Institute has more on genetic testing.

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