What does getting this marketing authorization mean for existing and <img loading="lazy" decoding="async" class="alignright size-medium wp-image-6586" src="https://blog-api.23andme.com/wp-content/uploads/2010/05/23andMe_Logo_blog-300x300.jpg" alt="23andMe_Logo_blog" width="300" height="300" srcset="https://blogcms.23andme.com/wp-content/uploads/2010/05/23andMe_Logo_blog-300x300.jpg 300w, https://blogcms.23andme.com/wp-content/uploads/2010/05/23andMe_Logo_blog-150x150.jpg 150w, https://blogcms.23andme.com/wp-content/uploads/2010/05/23andMe_Logo_blog-271x271.jpg 271w, https://blogcms.23andme.com/wp-content/uploads/2010/05/23andMe_Logo_blog.jpg 350w" sizes="auto, (max-width: 300px) 100vw, 300px" />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 direct-to-consumer genetic test granted marketing authority by the agency.
Because this process was successful, we may be able to submit some future submissions through the standard 510(k) pathway.
In addition to the authorization to market the Bloom Syndrome Carrier Status test report, the FDA is also classifying autosomal recessive carrier screening tests as class II with the intention to exempt such carrier tests from FDA premarket review.
According to the FDA’s press release, the “agency plans to issue a notice that announces the intent to exempt these tests and that provides a 30-day period for public comment. This action creates the least burdensome regulatory path for<a href="http://ghr.nlm.nih.gov/handbook/illustrations/autorecessive"> autosomal recessive</a> carrier screening tests with similar uses to enter the market.”


This is the first step in our commitment to returning health information to our customers.   We will continue to keep our community informed of our progress, but will not return results on individually cleared reports until we complete the regulatory process on additional health reports and have a more comprehensive product offering.

<h6>
What is Bloom syndrome?</h6>

Bloom syndrome is a rare disorder that is more common in people of Central and Eastern European, or Ashkenazi, Jewish background. One in 107 people of Ashkenazi Jewish descent are carriers for <a href="https://www.nature.com/gim/journal/v10/n6/full/gim200872a.html" target="_blank" rel="noopener noreferrer">Bloom syndrome</a>. The disorder is characterized by among other things short stature, sun-sensitive skin changes and an increased risk of cancer. According to the National Institute of Health, this condition is inherited in an autosomal recessive pattern, which means both copies of the gene in each cell have mutations.

<h6>
Does this mean 23andMe will again provide health reports to new customers in the US?</h6>

This is the first step in our commitment to returning health information to our customers.   We will continue to keep our community informed of our progress, but will not return health results on individually cleared reports until we have a more comprehensive product offering.

<h6>
Can I have access to my report for Bloom syndrome?</h6>

23andMe will not be making any health reports, including the report for Bloom syndrome Carrier Status test available to customers until we have a more comprehensive health product offering.

<h6>
What does it mean to be granted a de novo authorization?</h6>

23andMe submitted a 510(k) application for its direct-to-consumer Bloom syndrome Carrier Status Test.  A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is substantially equivalent to a legally marketed device. The submission was converted to a de novo request.
The Food and Drug Administration Modernization Act of 1997 (FDAMA) added the de novo classification option, which provides an alternate pathway to classify novel devices of low to moderate risk. The de novo process is used by the FDA to grant marketing authorization for a device when there is no substantially equivalent product with which to compare it.
De novo marketing authorization means that 23andMe met the FDA’s premarket requirements to demonstrate the following: accuracy, validity and user comprehension.
Devices that are classified through the de novo process may be marketed and used as predicates for future 510(k) submissions.

<h6>
What happened to the original 510(k) submission?</h6>

The original 510(k) submission was converted to a de novo request.  23andMe submitted a 510(k) application for its direct-to-consumer Bloom syndrome Carrier Status Test.  A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is substantially equivalent to a legally marketed device. The Food and Drug Administration Modernization Act of 1997 (FDAMA) added the de novo classification option, which provides an alternate pathway to classify novel devices. The de novo process is used by the FDA to grant marketing authorization for a device when there is no substantially equivalent product with which to compare it.

<h6>
When will you be getting clearance for the other health reports?</h6>

This submission was for one health report, and is part of the FDA’s regulatory review of our health product.   Although the submission focuses on a single rare but serious inherited condition we report to customers, Bloom syndrome, it is an important step in our work with the FDA in the coming months.
We believe there is a regulatory path forward for direct-to-consumer genetic testing. Working in close collaboration with the FDA, we believe we have begun to establish the parameters for future submissions.
More importantly, for our customers, it marks a baseline on the accuracy and validity of the Bloom syndrome Carrier Test information we will report back to them. The submission includes robust validation data covering major components of our product such as the genotyping chip, software and saliva kit.

<h6>
What will the future submissions be based upon?</h6>

Future submissions will be based on the learnings we gained during the Bloom syndrome review process. Because this process was successful, we may be allowed to provide some reports without premarket review and to submit some future submissions through the standard 510(k) pathway.

<h6>
What is the timing for those submissions?</h6>

We don’t have any specific timing for additional report submissions.

23andMe Blog

23andMe Blog Team

What The FDA Decision Means For 23andMe Customers

By Kathy Hibbs, Chief Legal and Regulatory Officer, 23andMe


A few days ago the US Food and Drug Administration accepted for review 23andMe’s submission for a new 510 (k) application. This submission is for one health report, and <img loading="lazy" decoding="async" src="https://blog-api.23andme.com/wp-content/uploads/2010/05/23andMe_Logo_blog-300x300.jpg" alt="23andMe_Logo_blog" class="alignright size-medium wp-image-6586" width="300" height="300" srcset="https://blogcms.23andme.com/wp-content/uploads/2010/05/23andMe_Logo_blog-300x300.jpg 300w, https://blogcms.23andme.com/wp-content/uploads/2010/05/23andMe_Logo_blog-150x150.jpg 150w, https://blogcms.23andme.com/wp-content/uploads/2010/05/23andMe_Logo_blog-271x271.jpg 271w, https://blogcms.23andme.com/wp-content/uploads/2010/05/23andMe_Logo_blog.jpg 350w" sizes="auto, (max-width: 300px) 100vw, 300px" />is part of the FDA&#8217;s regulatory review of our health product.


Although the submission focuses on a single rare but serious inherited condition we report to customers – <a href="http://ghr.nlm.nih.gov/condition/bloom-syndrome" target="_blank" rel="noopener noreferrer">Bloom syndrome</a> – it is an important step in our work with the FDA in the coming months.
Once cleared, it will help 23andMe, and the FDA, establish the parameters for future submissions.
More importantly, for our customers, it marks a baseline on the accuracy and validity of the information we report back to them. The submission includes robust validation data covering major components of our product such as the genotyping chip, software and saliva kit.


While we are still in the very early stages of this regulatory review process, we remain committed to transparency and keeping our customers as informed as possible. This by no means is the end of the process even for this one condition. It is likely that 23andMe will hear back from the FDA regarding the material we gave to them, and, we in turn will have to respond to those questions as we move forward.
We are pleased to be moving forward with the FDA and committed to our company mission of empowering individuals with their genetic information.


If you would like to know more about the 510 (k) process, you can read more on the <a href="https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm" target="_blank" rel="noopener noreferrer">FDA’s website</a>.

Kathy Hibbs

Update On The Regulatory Review Process With The FDA

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 – drove a lot of the most interesting discussions on the interactive side of the festival.<img loading="lazy" decoding="async" class="alignright size-medium wp-image-20629" alt="anne before interview copy" src="https://blog-api.23andme.com/wp-content/uploads/2014/03/anne-before-interview-copy-199x300.jpg" width="199" height="300" srcset="https://blogcms.23andme.com/wp-content/uploads/2014/03/anne-before-interview-copy-199x300.jpg 199w, https://blogcms.23andme.com/wp-content/uploads/2014/03/anne-before-interview-copy-768x1155.jpg 768w, https://blogcms.23andme.com/wp-content/uploads/2014/03/anne-before-interview-copy-681x1024.jpg 681w, https://blogcms.23andme.com/wp-content/uploads/2014/03/anne-before-interview-copy-585x880.jpg 585w, https://blogcms.23andme.com/wp-content/uploads/2014/03/anne-before-interview-copy-784x1180.jpg 784w, https://blogcms.23andme.com/wp-content/uploads/2014/03/anne-before-interview-copy.jpg 1330w" sizes="auto, (max-width: 199px) 100vw, 199px" />
23andMe’s CEO and co-founder Anne Wojcicki delivered one of the more popular keynotes. While she tried to answer most of the questions directed to her through Twitter using the #AskAnne hashtag, she ran out of time quickly. So we went back through the more than 100 queries to answer the most frequently asked questions.
<h6>What about the FDA?</h6>
The biggest question, the one that’s been dominating our work over the last few months, asked by many on Twitter was summed up by Armin Molvai (@amolavi), who asked: “Can you share and update on what’s happening with the FDA?”
Back in November, the FDA ordered 23andMe to stop returning health results to new customers, pending completion of a regulatory process, that requires submitting applications that detail the validity of the testing and science behind health results returned to customers. How long that process will take is hard to say, but Anne made clear that 23andMe is still deeply invested in seeing it through.
“My main priority is a resolution with the FDA,” she<a href="https://venturebeat.com/2014/03/12/23andme-ceo-we-need-to-return-to-delivering-health-information/"> told Venture Beat</a> writer Christina Farr after her keynote. “We’re not going to switch gears and become an ancestry company, although that’s a huge market on its own. We need to return to delivering health information.”
<h6>Working through the Process</h6>
Knowing how the FDA process has changed what 23andMe can offer new customers, Melissa Green (@mgreenvml) asked on Twitter how that will impact the company’s ongoing research.
Anne’s message on that was that not only is the company continuing to do research, but 23andMe is also tackling new areas of study. 
<iframe loading="lazy" width="560" height="315" src="//www.youtube.com/embed/6A4wtpHZCQI" allowfullscreen="allowfullscreen" frameborder="0"></iframe>
“We have 650,000 people in our database and are being inundated with requests from academics and foreign partners,” she said. “We have more of this data than anyone else in the world.”
The mission of the company has always been about changing health care and empowering people with their genetic information. And 23andMe’s research is central to that mission, Anne said.
<h6>Research</h6>
With 23andMe people can learn about themselves while helping to power important genetic research. Most of our customers consent to research. Collectively those customers have answered more than 170 million survey questions that in turn helps fuel research that now extends to more than 230 different studies looking at 1,000 different conditions that span everything from Parkinson’s disease to motion sickness. That’s the kind of research that could not be accomplished using traditional methods
While many at the conference could easily grasp the power 23andMe’s big data to speed research, some others were concerned about privacy around that data and, “how (23andMe is) protecting this database?”
Anne’s response was that research is done using data that is made anonymous, that the company adheres to strict security protocols. And our research is overseen by an independent “Institutional Review Board” that objectively looks out for the interests of those who consent to research. In the end, Anne pointed out that customers can opt-out of research at any time, download their data and close their account.
“One of the reasons we went direct to consumer is so that you own the data,” she said. “And if you then want to share it that’s your right.”

More From SXSW #AskAnne

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.<img loading="lazy" decoding="async" src="https://blog-api.23andme.com/wp-content/uploads/2011/12/top10ten-266x300.jpg" alt="top10ten" class="alignright size-medium wp-image-10750" width="266" height="300" srcset="https://blogcms.23andme.com/wp-content/uploads/2011/12/top10ten-266x300.jpg 266w, https://blogcms.23andme.com/wp-content/uploads/2011/12/top10ten.jpg 306w" sizes="auto, (max-width: 266px) 100vw, 266px" />
We want to include in our list a few things that aren’t findings or discoveries, but clearly, these stories have had a huge impact on the field of genetics. The fact that these stories made such a big splash beyond the world of science and health reporting illustrates how important genetics has become for everyone.
As far as research goes, in the last year, we’ve seen the continued rapid pace of discovery in genetic sciences. These new findings have included research into the biology of disease, mental illness and new insights into our understanding of human evolution. Researchers here at 23andMe are also a part of this push to understand not just the human story, but the biology of disease and the role genetics plays in our lives.
So let’s take a quick look back at the last year and 23andMe’s list of the Top Ten Genetic Stories of 2013.
<h6> THE ANGELINA EFFECT<img loading="lazy" decoding="async" src="https://blog-api.23andme.com/wp-content/uploads/2013/12/Angelina-image-196x300.jpg" alt="46th New York Film Festival &quot;Changeling&quot; Premiere - Inside Arrivals" class="alignright size-medium wp-image-20131" width="173" height="265" /></h6>
Angelina Jolie’s<a href="https://www.nytimes.com/2013/05/14/opinion/my-medical-choice.html"> revelation</a> that she underwent a double prophylactic mastectomy after learning she had a mutation in the BRCA1 gene, brought genetic screening into sharp focus for everyone. In making her difficult choice, she took into consideration her family history – her mother died of ovarian cancer (also associated with BRCA1 gene mutation) and her aunt also had breast cancer   – her ancestry and her age. Going public with her story also offered comfort to many women facing similar choices.
<h6>EWWW</h6>
It probably wasn’t what Walt Whitman<a href="http://www.daypoems.net/plainpoems/1900.html"> meant</a>, but indeed we all “contain multitudes.” Our bodies are host to literally trillions of microorganisms that make up the “human microbiome,” and those organisms play a very important but not fully understood role in our health. There is also a link between the make-up of that microbiome and the genetic variation of our immune systems, which is another thing we haven’t yet fully figured out. But even without fully understanding how these all interrelate, doctors have started to use these important microorganisms to treat illnesses. Early in the year, the New England Journal of Medicine published a study that followed 16 patients who were treated for a severe gut infection with a<a href="https://www.nature.com/news/faecal-transplants-succeed-in-clinical-trial-1.12227"> fecal transplant.</a> While it might be something you’d rather not talk about over dinner, the treatment of the Clostridium difficile infection worked in 15 of the 16 patients.
<h6>FIVE MENTAL ILLNESSES SHARE A COMMON GENETIC LINK</h6>
A<a href="http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2812%2962129-1/fulltext"> study published in early 2013</a> found that five very distinct psychiatric disorders share an association with some variants in genes that control signaling in the brain. The large study looked at schizophrenia, bipolar disorder, autism, major depression and attention deficit hyperactivity disorder. Although these are very different conditions, the findings may help researchers better understand the underpinnings of these very different illnesses. Two of the four variants involve calcium channels, integral for signaling within the brain.
<h6 dir="ltr">NOTHING TO SNEEZE AT<img loading="lazy" decoding="async" src="https://blog-api.23andme.com/wp-content/uploads/2010/03/allergy.jpg" alt="allergy" class="alignright size-full wp-image-6151" width="198" height="176" /></h6>
There’s an ongoing debate about the interplay between genetics and the environment in why there has been an apparent increase in the rate of allergies. There are many theories offered to explain this including the “<a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2841828/">hygiene hypothesis</a>,” which suggests that an increasingly sanitized environment inhibits the development of the immune system.  Another theory is that increased exposure to chemicals and pollutants are the culprits. The rate of <a href="http://www.jacionline.org/article/S0091-6749%2805%2901314-X/abstract">allergies</a> has more than<a href="https://www.cdc.gov/nchs/data/databriefs/db10.htm#howdoes"> doubled over the last decade</a>.   While this increase is pointing to environmental factors, genetics is an important component.
A study done by 23andMe scientists and researchers at the University of Bristol’s<a href="http://www.bristol.ac.uk/alspac/"> Avon Longitudinal Study of Parents and Children (ALSPAC)</a> in the UK found <a href="https://mediacenter.23andme.com/press-releases/allergies_2013">new genetic associations for asthma and allergies</a>. It was the largest genome-wide association study ever conducted on common allergies with data from more than 53,000 people. The study showed that there are also common genetic variants underlying allergies to cats, pollen and dust mites
<h6>HUMAN GENES CAN’T BE PATENTED</h6>
Not long after Angelina’s revelation, the Supreme Court unanimously decided to bar the patenting of human genes. The case involved Myriad Genetics, which has long held patents for breast and ovarian cancer screening. What’s not so clear from the Supreme Court’s decision is what sort of impact this decision will have on research and innovation. While several companies almost immediately jumped into BRCA testing, legal challenges by Myriad to   stop those efforts quickly followed, leaving more doubt about how this will all play out.
<h6>THE WAY BACK<img loading="lazy" decoding="async" src="https://blog-api.23andme.com/wp-content/uploads/2013/05/neanderthal.jpg" alt="neanderthal" class="alignright size-full wp-image-18144" width="150" height="270" /></h6>
Scientists extracted DNA from a 400,000-year-old thigh bone found buried in a Spanish cave, known as<a href="https://www.nature.com/nature/journal/vaop/ncurrent/full/nature12788.html"> Sima de Los Huesos, or Pit of Bones.</a>  Apart from the big deal of extracting genetic material from a really, really old bone – the oldest human DNA recovered yet – the find also gives us more information about human evolution, namely that it’s not as linear as some have thought. The DNA in the bone resembled that of ancient humans known as Denisovan.
Because of the time frame and the location, many had thought the bones would be from Neanderthals. The Denisovan DNA was a bit of a head-scratcher. Previous finds placed Denisovans in Siberia and only at about 80,000 years ago. Clearly, this adds more nuances to the story of human evolution. We can also add more pieces to that understanding after another DNA find this year. DNA from the 24,000-year-old skeletal remains of a boy buried near Lake Baikal in Siberia, has also altered researchers&#8217; view of the migration patterns of early Europeans.
The DNA matched not just with Western Europeans but with Native Americans. This suggests that the earliest people to settle the Americas were<a href="http://www.sciencemag.org/content/342/6157/409.full"> a mix of both populations.</a> While previous research has suggested that Native Americans descended from people who migrated from Siberia, this overlap with early Europeans is new. It also suggests that during the last Ice Age, people from Europe had migrated farther east than previously thought.
<h6>ALZHEIMER’S SEQUENCE DATA – CHAPTER ONE</h6>
The more information we can collect from people with the disease, the better we can understand them. Researchers working on Alzheimer’s disease got a huge boost in their efforts this year after the first batch of genetic data was<a href="http://www.nih.gov/news/health/dec2013/nhgri-02.htm"> made available</a> as part of the<a href="https://www.niagads.org/adsp/"> Alzheimer&#8217;s Disease Sequencing Project</a>. The project, conducted by the National Institutes of Health, makes available full genome sequence data on 410 people with Alzheimer’s. The hope is that by offering this information to a wide range of researchers, it will open up the possibility of new discoveries.
<h6>SHARING DATA<img loading="lazy" decoding="async" src="https://blog-api.23andme.com/wp-content/uploads/2009/06/atcg-200x200.jpg" alt="DNA code analysis" class="alignright size-thumbnail wp-image-3837" width="200" height="200" /></h6>
Hundreds of institutions worldwide are currently doing clinical and genetic research. If you could share that data and standardize how it is reported, you could make it that much more useful. That’s exactly what more than 70 medical, research and advocacy organizations did this year, the National Institutes of Health among them. They all agreed to set up a system<a href="https://www.broadinstitute.org/news/globalalliance"> to share genetic and clinical information</a>. By creating a database of genetic variation and health information, it would offer researchers, and doctors, a powerful resource for discovery.
Illustrating the power of shared data, using data from the Electronic Medical Records Genomics Network<a href="https://www.genome.gov/27540473"> (eMERGE</a>) for short – researchers have identified dozens of new variants linked to diseases ranging from skin cancer to anemia. The eMERGE data set allowed researchers to search by gene variant to find associated conditions. As the database grows it will allow researchers to discover connections between seemingly unrelated diseases and genetic variants.
The power of big datasets that include not just genetic information but also phenotypic information, is part of what 23andMe is all about. This year 23andMe researchers leverage our database and certain phenotypes to  functionally classify different genetic associations. our researchers presented some of our findings on this at the ASHG conference this year in Boston. Their findings show that on occasion, a single genetic variant will be associated with multiple different phenotypes. So for example, in autoimmune diseases, a single SNP influences multiple different diseases. Sometimes these shared associations are more surprising, such as the genetic association shared by both<a href="https://blog.23andme.com/health-traits/23andmes-latest-publication-shines-light-on-male-pattern-baldness-and-unexpected-associations-with-disease/"> Parkinson’s disease and baldness</a>. We’ve also found correlations between breast cancer and breast size, body mass index and food choice, and hair color and skin cancer.
<h6>MY, WHAT LONG TELOMERES YOU HAVE</h6>
Several papers this year indicate that genetic variants in telomere genes (such as TERT, TERC, POT1, etc.) not only influence the length of telomeres, which in turn is a good indicator of longevity, but those variants are also associated with certain cancers. Researchers in several different Genome-Wide Association Studies have found links to cancers such as multiple myeloma,<a href="https://www.ncbi.nlm.nih.gov/pubmed/23535731"> breast and ovarian cancer</a>, testicular cancer,<a href="https://www.ncbi.nlm.nih.gov/pubmed?cmd=retrieve&#038;list_uids=23143601&#038;dopt=citation"> lung cancer,</a> and chronic<a href="https://www.nature.com/ng/journal/v45/n5/full/ng.2584.html"> lymphocytic leukemia</a>.
<h6>23ANDME AND THE FDA</h6>
It’s not the kind of news we like, but there’s no way for us to do a roundup of the year&#8217;s big stories without mentioning that the FDA in December ordered 23andMe to stop offering new consumers access to their health-related genetic tests, while the company moves through the FDA’s regulatory review process. 23andMe remains committed to being a pioneer in the genetics revolution and has made its work with the FDA its top priority.
Making it all work will be good not just for the FDA and 23andMe, but for the future of the direct-to-consumer genetic testing industry. Individuals who want to understand their genetics will win too – that’s everyone’s goal. Here’s to 2014.

This Year’s Top Ten Genetic Findings of 2013

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 genetic tests while the company moves forward with the agency’s regulatory review <img loading="lazy" decoding="async" class="alignright size-medium wp-image-6586" src="https://blog-api.23andme.com/wp-content/uploads/2010/05/23andMe_Logo_blog-300x300.jpg" alt="23andMe_Logo_blog" width="300" height="300" srcset="https://blogcms.23andme.com/wp-content/uploads/2010/05/23andMe_Logo_blog-300x300.jpg 300w, https://blogcms.23andme.com/wp-content/uploads/2010/05/23andMe_Logo_blog-150x150.jpg 150w, https://blogcms.23andme.com/wp-content/uploads/2010/05/23andMe_Logo_blog-271x271.jpg 271w, https://blogcms.23andme.com/wp-content/uploads/2010/05/23andMe_Logo_blog.jpg 350w" sizes="auto, (max-width: 300px) 100vw, 300px" />processes.
23andMe has been giving consumers access to health information for six years and is committed to finding the right regulatory path for our customers.  I am highly disappointed that we have reached this point and will work hard to make sure consumers have direct access to health information in the near future.  Our goal is to work cooperatively with the FDA to provide that opportunity.
We also want to make clear that we stand behind the data we have generated for customers. Our lab partner adheres to strict quality standards that are part of the <a href="https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/IVDRegulatoryAssistance/ucm124105.htm">Clinical Laboratory Improvement Amendments of 1988</a> – known as CLIA. These are the same standards used in the majority of other health and disease-related tests. We decided several years ago to comply with CLIA guidelines to be consistent with other types of laboratory testing and to assure customers about the quality of data.
As we work with the FDA to get clearance, there will be some significant changes to the site.  Customers who purchased kits on or after the FDA’s warning letter of November 22nd will not have access to health-related results. Those customers will have access to ancestry-related genetic information and their raw data without 23andMe’s interpretation of that data. They may receive health-related results in the future, depending on FDA marketing authorization.
Customers who purchased kits before November 22, 2013 will continue to have access to all the reports they’ve always had.
This is clearly a much different service than in the past, so we are offering customers who purchased kits on or after November 22, 2013 a full refund if they wish. Those customers will get an email from 23andMe with details on the refund policy. Eligible customers who do not receive an email are encouraged to check their spam email folders for the email with their personalized instructions or contact our Customer Care Team.
Research is and will continue to be a significant priority for the company.  The 500,000+ customers we have today have given us more than 250 million survey data points.  You, our customer, have powered an incredibly important crowd-sourced research database that I believe can have a significant impact on the pace of discoveries and cures. We will continue our Parkinson’s, sarcoma, MPN and African American research projects and plan to launch more communities in 2014.
23andMe will also continue educational efforts to consumers, physicians and other health providers as we believe genetics will be an increasingly important part of all of our lives.
Finally, I want to say thank you to our customers for your support and your stories.  Many of you have written in about how 23andMe has changed your life.  It is rewarding for me and all the employees at 23andMe to serve our customers.  I am committed to 23andMe and committed to being a pioneer in the genetics revolution.

Anne Wojcicki

23andMe’s Updates Regarding FDA’s Review

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.<img loading="lazy" decoding="async" class="alignright size-medium wp-image-6586" alt="23andMe_Logo_blog" src="https://blog-api.23andme.com/wp-content/uploads/2010/05/23andMe_Logo_blog-300x300.jpg" width="300" height="300" srcset="https://blogcms.23andme.com/wp-content/uploads/2010/05/23andMe_Logo_blog-300x300.jpg 300w, https://blogcms.23andme.com/wp-content/uploads/2010/05/23andMe_Logo_blog-150x150.jpg 150w, https://blogcms.23andme.com/wp-content/uploads/2010/05/23andMe_Logo_blog-271x271.jpg 271w, https://blogcms.23andme.com/wp-content/uploads/2010/05/23andMe_Logo_blog.jpg 350w" sizes="auto, (max-width: 300px) 100vw, 300px" />
It is absolutely critical that our consumers get high quality genetic data that they can trust.  We have worked extensively with our lab partner to make sure that the results we return are accurate.  We stand behind the data that we return to customers – but we recognize that the FDA needs to be convinced of the quality of our data as well.
In 2008 we began our dialogue with the FDA. The relationship with the FDA remains critically important to 23andMe.
In July 2012 23andMe submitted its first application for FDA clearance and followed on with another submission at the end of August. We received feedback on those submissions and acknowledge that we are behind schedule with our responses.
This is new territory for both 23andMe and the FDA. This makes the regulatory process with the FDA important because the work we are doing with the agency will help lay the groundwork for what other companies in this new industry do in the future. It will also provide important reassurance to the public that the process and science behind the service meet the rigorous standards required by those entrusted with the public’s safety.
I am committed to making sure that 23andMe is a trusted consumer product. I believe that genetic information can lead to healthier lives &#8212; a goal that all of us share.
We will provide updates as they become available.

An Update Regarding The FDA’s Letter to 23andMe

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 relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns.

23andMe Statement Regarding FDA Warning Letter

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.”<img loading="lazy" decoding="async" class="alignright size-medium wp-image-8468" src="https://blog-api.23andme.com/wp-content/uploads/2011/02/iStock_000014686955XSmall-300x199.jpg" alt="Flour wheat celiac" width="300" height="199" srcset="https://blogcms.23andme.com/wp-content/uploads/2011/02/iStock_000014686955XSmall-300x199.jpg 300w, https://blogcms.23andme.com/wp-content/uploads/2011/02/iStock_000014686955XSmall.jpg 425w" sizes="auto, (max-width: 300px) 100vw, 300px" />
The new standards are hugely important for the more than 3 million Americans with celiac disease as well as many others who for other reasons may need to avoid gluten.
Gluten, a protein found in wheat, triggers a mistaken immune response in those with <a href="http://www.celiacdiseasecenter.org/">Celiac</a>. This in turn can damage the lining of the small intestines and undermine the absorption of nutrients, ultimately causing symptoms that range from stomachaches to diarrhea and iron deficiency.
For those without Celiac who are also trying to avoid gluten – namely people who have allergies to wheat or simply a gluten intolerance – <a href="https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Allergens/ucm362880.htm">the new standards</a> are also important.
Now anyone buying food with a “gluten-free” label, knows that means that to get that label the food must contain less than 20 parts per million of gluten.

New Standards Regulating Gluten Labeling

<img loading="lazy" decoding="async" class="alignright size-medium wp-image-1400" title="bloodclot" alt="" src="https://blog-api.23andme.com/wp-content/uploads/2008/09/bloodclot-300x222.jpg" width="300" height="222" />
A <a href="http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2812%2960986-6/abstract" target="_blank" rel="noopener noreferrer">study</a> 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 attacks or strokes.
The mostly commonly used blood thinner, warfarin (Coumadin ®) has proven to be a godsend for millions of people at risk, but this study suggests that as many as half of those who use the drug do not benefit from it because of challenges related to finding the proper dose.
Calibrating the right prescription of warfarin is notoriously difficult because the right amount depends not just on such things as a person’s size, their diet and age, but also, importantly,their genes.
The new study isn’t about genetics. It’s by<a href="http://www.dukehealth.org/health_library/news/apixaban-superior-to-warfarin-across-wide-range-of-patient-risk-scores"> researchers at Duke Medical Center</a>, who suggest that the new blood thinner apixaban is safer than warfarin and more effective at preventing strokes in people who have atrial fibrillation, a common heart rhythm disorder.
Apixaban hasn’t<a href="https://www.forbes.com/sites/larryhusten/2012/09/27/fda-sets-new-decision-date-for-eliquis-aprixaban/"> yet received FDA approval</a>. That may soon change, but the study reminds us of all the challenges with current drugs and the tremendous amount of resources invested into finding drugs that are safe and effective for more people. Another complementary way to achieve that goal is by learning more about how individual patients may respond to specific drugs. Your genetics are a big part of that equation.
In the case of warfarin, aperson’s genetic<a href="https://www.23andme.com/health/Warfarin-Coumadin-Sensitivity/">s</a> directly impacts how sensitive they are to the drug. Although there are a number of factors that influence a person’s optimal dose of warfarin, genetic variations in the CYP2C9 and the VKORC1 genes play an important role in how the body responds to the drug. More than two years ago the FDA updated the labeling on warfarin to make note of this genetic influence but genetic testing is not required before prescribing warfarin.

Related posts: 
 &#8211;<a href="../2009/02/19/new-study-shows-that-genetic-information-can-improve-administration-of-commonly-used-blood-thinner/"> New Study Shows That Genetic Information Can Improve Administration Of Commonly Used Blood Thinner</a> 
&#8211;<a href="../big-questions/a-prescription-for-personalizing-medicine/"> A Prescription for Personalizing Medicine</a> 
&#8211; <a href="../news/announcements/23andme-launches-first-national-institutes-of-health-funded-study/">23andMe Launches Its First NIH Funded Study</a>

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