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FDA to Hold Public Town Hall Discussion in San Francisco
In March earlier this year, 23andMe presented its views on possible federal regulation of the direct-to-consumer (DTC) genetic testing industry at an Advisory Committee meeting convened by the FDA. We...
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The Debate Over Clopidogrel Continues
In December a new study created quite a stir in the already-volatile clopidogrel research community. Clopidogrel (trade names Plavix®) is a commonly prescribed anti-clotting drug. It is inactive in...
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Hope in a Pill: New Treatment for Cystic Fibrosis Approved
The realization of a long-awaited hope arrived this past month for many families in the form of a new treatment for cystic fibrosis. Cystic fibrosis (CF) is one of the most common recessively...
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23andMe Takes First Step Toward FDA Clearance
Today 23andMe announced that we’ve submitted our first round of 510(k) documentation to the U.S. Food and Drug Administration (FDA). The application provides a detailed description of our Personal...
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Blood Thinners and the Genetics Behind Drug Response
A study in the journal Lancet regarding a new blood thinning drug brings to mind the difficulty doctors and patients have in using anticoagulants to prevent clots that could otherwise lead to heart...
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New Standards Regulating Gluten Labeling
New rules issued by the US Food and Drug Administration earlier this month mean we may finally know what it means when a label on food we buy says “Gluten-Free.” The new standards are hugely important...
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23andMe Statement Regarding FDA Warning Letter
We have received the warning letter from the Food and Drug Administration. We recognize that we have not met the FDA’s expectations regarding timeline and communication regarding our submission. Our...
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An Update Regarding The FDA’s Letter to 23andMe
23andMe was started in 2007 with the belief that consumers have the right to get access to their genetic information and that information can help them live healthier lives. It is absolutely critical...
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23andMe Provides An Update Regarding FDA’s Review
By Anne Wojcicki After discussion with officials from the Food and Drug Administration today, 23andMe will comply with the FDA’s directive and stop offering new consumers access to health-related...
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This Year’s Top Ten Genetic Findings
Each year at this time 23andMe puts together a list of the most interesting genetic findings of 2013. We’re doing that again but with a twist. We want to include in our list a few things that aren’t...
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23andMe Looks Back One More Time
In honor of the Chinese New Year, we’re taking one last look at the genetic milestones of 2013. From a Supreme Court ruling on patenting genes, to Angelina Jolie’s bold revelations about her genetic...
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More From SXSW #AskAnne
We can’t tell you the breakout bands or best films from this year’s South By Southwest, but we can tell you that new ideas around digital health — including 23andMe’s use of big data to power research...
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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....
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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...
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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...
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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...
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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...
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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 a RNA-profiling to measure and...
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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. Paul Cannon,...
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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...
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