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FDA Approves 23andMe Direct-To-Consumer Testing.

After years of back and forth, the (https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm551185.htm) Federal Drug Administration granted market authorization to the at-home genetic DNA test 23andMe. The test 23andMe will be allowed to sell directly to consumers include genetic test to determine whether or not consumers have a predisposition to genetic diseases.

The "Personal Genome Service Genetic Health Risk" tests the FDA approved include tests for Parkinson's disease, Celiac disease and late-onset Alzheimer's among others.

Read: (http://www.ibtimes.com/new-test-can-identify-what-blood-type-you-are-less-minute-2510743) New Test Can Identify What Blood Type You Are In Less Than A Minute

The company was (https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm376296.htm) warned via formal written letter from the FDA advising that the company needed marketing clearance and approval from the administration before going forward with direct-to-consumer marketing.

The at-home test is (https://www.23andme.com/howitworks/) easily conducted with a saliva collection kit that users then mail back to a lab. The 23andMe emails you when your genetic results have been process and added to your online profile with the company. It's fairly quick, painless and easy way to learn what genetic predispositions you may have.

"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," said Jeffrey Shuren, M.D., director of the FDA's Center for Devices and Radiological Health in a (https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm551185.htm) release.

Just because you're genetically predisposed to a disease does not mean you will develop it. The FDA wanted to (https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm551185.htm) make sure that users could easily understand their results and were aware that genetic predisposition was only one factor of overall health before approving the test for direct-to-consumer marketing. The FDA ran tests to see how clear the information users were given was and found that people using the test understood 90 percent or more of the information they were given.

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Publication:International Business Times - US ed.
Date:Apr 7, 2017
Words:342
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