Tag: FDA

The FDA Wants To Hear Your Opinion

If you have an opinion about genetic testing and the best way to return those results, the U.S. Food and Drug Administration (FDA) wants to hear it at a daylong workshop scheduled for March 2nd. The meeting offers the FDA a chance to get perspectives from the public and medical professionals on how best to ...

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This Year’s Top Ten Stories in Genetics

Starting in January with the launch of the ambitious Precision Medicine Initiative in the United States, 2015 finished with a heated debate around the appropriate use of technology that allows scientists to edit the human genome. Those two big stories bookended the year showing both the promise and peril of ...

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A New 23andMe Experience

23andMe made some news today, with the launch of a new experience for customers that includes the first and only direct-to-consumer genetic service that meets U.S. FDA standards. We invested nearly two years of work conducting extensive user testing, working with regulators, scientists, physicians, and top ...

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Patients Perspective on Parkinson’s Disease

As federal regulators listened, patients told them of their symptoms — the sleepless nights, the days with uncontrollable tremors or the little struggles simply maintaining their balance. Some of those with Parkinson’s who spoke at the special U.S. Food and Drug Administration meeting in late ...

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Live Long And Prosper

We all measure our age in years, but results of a study lead by researchers at Kings College in London found what may be a better measurement of age — your genes. Using RNA-profiling to measure and compare gene expression in thousands of tissue samples, the researchers were able to develop what amounts ...

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A Note to Our Customers Regarding the FDA

By Anne Wojcicki Today, 23andMe was granted authorization by the U.S. Food and Drug Administration (FDA) to market the Bloom syndrome carrier status report. This is an important first step in fulfilling our commitment to return genetic health reports to consumers in the US. This is also the first-time ...

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What The FDA Decision Means For 23andMe Customers

What does getting this marketing authorization mean for existing and future customers? As the first direct to consumer genetic test to complete the regulatory pathway, 23andMe’s Bloom Syndrome Carrier Status test was given marketing authorization through the de novo pathway. This is the first ...

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Drug Development’s Long And Winding Road

Before a medicine reaches pharmacy shelves, it goes through extensive and rigorous evaluation to prove it is safe and effective. We want to shed some light on a few of the steps involved in drug development and highlight how the work being done by 23andMe with the Inflammatory Bowel Disease Study can help ...

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23andMe In The News

Last week was a good one for research at 23andMe with two announcements that offer more examples of the power of our research model. First was the publication of a massive Parkinson’s disease study that our scientists worked on with a consortium of 50 other organizations that were lead by researchers at ...

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A “Bio Buzz” Interview with Anne Wojcicki

In San Diego at the annual Bio International Convention where she gave the keynote for a forum on personalized medicine, 23andMe CEO and Co-Founder Anne Wojcicki gave a short interview to Mike Huckman. Check it out here: ...

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