Scientists at the University of Washington’s Department of Genome Sciences, report that they can zero in on remnant Neanderthal DNA in modern humans.
They have identified specific regions in our genome where that ancient DNA resides, and they can do this even without access to actual Neanderthal DNA samples from fossilized bones.
<h6><img loading="lazy" decoding="async" class="alignright size-full wp-image-20253" src="https://blog-api.23andme.com/wp-content/uploads/2014/01/Neanderthal_model.jpg" alt="Neanderthal_model" width="260" height="270" />Neanderthal Traits</h6>
The study published this week in Science promises to help researchers working not just in addressing questions about human evolution, but those investigating the underpinnings of human traits and complex diseases.
Up to this point, scientists using tools – like the one developed by 23andMe – could make estimates about the amount of overall Neanderthal DNA in modern humans, but this new technique could help researchers bore down on where in the genome that DNA resides.
That could give us greater insight into how the Neanderthals DNA changed modern humans, including what sort of traits and conditions they conferred onto Homo sapiens.
<h6>Evolutionary Success</h6>
There are many theories regarding the influence Neanderthal DNA had on modern humans. Some have pointed to Neanderthal DNA as a culprit in certain cancers, in autism and diabetes. But it is also likely that modern humans benefited from interbreeding and that Neanderthal DNA may have played a large role in<a href="http://www.scientificamerican.com/article/sex-with-other-human-species-might-have-been-secret-homo-sapiens/"> our evolutionary success</a>.
Over the last few years, we’ve learned that most non-Africans carry some remnant Neanderthal DNA. But what that might mean – what characteristics, diseases or conditions that we modern humans carry with us because of that DNA – is still unclear.
<h6>Neanderthal Sequence</h6>
Just last month researchers from the Max Planck Institute for Evolutionary Anthropology sequenced the full genome of a Neanderthal woman. They did this by extracting DNA from her 50,000-year-old fossilized toe bone found at a site in Siberia. The sequence was done at a quality comparable to what would be done for a living person. And the researchers were able to use the sequence to show how genes flowed between these populations.
This and other breakthroughs have only increased the pace of our changing understanding of early human evolution. As we learn more, our curiosity about those early cousins only seems to grow.
Take a look at these new illustrations of Neanderthals done for an exhibit called Britain. It&#8217;s called One Million Years of Human History and was put together by the National History Museum in the UK.
<iframe loading="lazy" src="//www.youtube.com/embed/znUvFxsrMOs" width="560" height="315" frameborder="0" allowfullscreen="allowfullscreen"></iframe>
<img loading="lazy" decoding="async" class="alignright wp-image-14049" title="neanderthal icon" src="https://blog-api.23andme.com/wp-content/uploads/2012/06/neanderthal-icon-96x150.jpg" alt="" width="50" height="77" />
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23andMe customers can find their inner Neanderthal or at least how much Neanderthal DNA they have. Not yet a customer? <a href="https://www.23andme.com/store">Visit our store</a>!

23andMe Blog

23andMe Blog Team

More Neanderthal

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

In the New Year, 23andMe will give out a gift for kids and promote literacy at the same time. We deliver 500 copies of our illustrated board book You Share Genes With Me to<img loading="lazy" decoding="async" class="alignright size-full wp-image-20111" src="https://blog-api.23andme.com/wp-content/uploads/2013/12/you-share-genes-with-me.jpg" alt="you-share-genes-with-me" width="222" height="221" srcset="https://blogcms.23andme.com/wp-content/uploads/2013/12/you-share-genes-with-me.jpg 222w, https://blogcms.23andme.com/wp-content/uploads/2013/12/you-share-genes-with-me-150x150.jpg 150w" sizes="auto, (max-width: 222px) 100vw, 222px" />
<h2>Books for Kids</h2>
Books for Kids is a non-profit organization based in New York City. Its mission is to promote literacy among children. They focus a lot on low-income and at-risk preschool-aged children. Books for Kids creates libraries, donates books, and implements literacy programs to develop the critical early foundation and skills young children need to succeed. The organization focuses, in particular, on low-income preschool-aged children who live in homes where there are fewer than five books. The foundation wants to ensure those families have books to engage, entertain, and educate children.
The organization focuses, in particular, on low-income preschool-aged children who live in homes with fewer than five books. The foundation wants to ensure that those families have books that can engage, entertain, and educate children.
<h2>You Share Genes with Me</h2>
23andMe wants that, too, and the foundation’s commitment aligns with our broader education mission.
“It&#8217;s always been our mission to improve genetic literacy for everyone regardless of age,” said Esther Kim, Pharm. D., who heads up 23andMe’s education efforts.
In addition to the gift to Books for Kids, 23andMe also offers free books to the first 500 elementary school teachers who <a href="https://www.23andme.com/yousharegeneswithme/" target="_blank" rel="noopener">register</a>. Each teacher will get two copies of the book for their classrooms. We hope the book will help bring a greater diversity of learning levels into our academic program, which has historically focused more on high school, undergrad, and medical school programs.
<div id="attachment_20114" style="width: 271px" class="wp-caption alignright"><img loading="lazy" decoding="async" aria-describedby="caption-attachment-20114" class="wp-image-20114 size-medium" src="http://35.88.189.111/wp-content/uploads/2013/12/book_flyer-copy21-261x300.jpg" alt="" width="261" height="300" srcset="https://blogcms.23andme.com/wp-content/uploads/2013/12/book_flyer-copy21-261x300.jpg 261w, https://blogcms.23andme.com/wp-content/uploads/2013/12/book_flyer-copy21-768x883.jpg 768w, https://blogcms.23andme.com/wp-content/uploads/2013/12/book_flyer-copy21-891x1024.jpg 891w, https://blogcms.23andme.com/wp-content/uploads/2013/12/book_flyer-copy21-765x880.jpg 765w, https://blogcms.23andme.com/wp-content/uploads/2013/12/book_flyer-copy21-1026x1180.jpg 1026w, https://blogcms.23andme.com/wp-content/uploads/2013/12/book_flyer-copy21.jpg 1275w" sizes="auto, (max-width: 261px) 100vw, 261px" />A look inside the book You Share Genes With Me.</div>
“We are excited to reach out to communities we typically don&#8217;t have access to through our normal distribution channels,” said Esther. “ We hope this book can plant in children’s minds a seed of curiosity for genetics and science and help them to realize how genes connect us to all living things.”
<h2>Genetics 101</h2>
We’ve done that with our <a href="https://www.23andme.com/gen101/genes/">Genetics 101 series</a>, our work with several educational institutions, and our partnership with Udacity to produce an online genetics class. We were also involved in helping put together a genetics exhibit with the Smithsonian earlier this year. The children’s book, a sweet picture book showing kids how much DNA they share with other living things, came together, partly from all that work.
The book, illustrated by Arianna Killoran, offers a whimsical look at genetics. It’s meant to provide kids with an introduction to science by emphasizing how much DNA we share with other species and each other. Humans are about 99.5 percent similar genetically, but that little difference makes us all unique. The book discusses how humans share DNA with other species, like zebrafish, mice, and chimpanzees. While the book is not currently available for sale online, it can be purchased at the gift shops of the Smithsonian in Washington, D.C., and at The Exploratorium in San Francisco.

23andMe’s Science Book For Kids

Our favorite ancient cousins, the Neanderthals, are in the news again.
Researchers from the Max Planck Institute for Evolutionary Anthropology<img loading="lazy" decoding="async" class="alignright wp-image-421 size-medium" src="http://35.88.189.111/wp-content/uploads/2008/07/neanderthaler2-300x200.jpg" alt="" width="300" height="200" srcset="https://blogcms.23andme.com/wp-content/uploads/2008/07/neanderthaler2-300x200.jpg 300w, https://blogcms.23andme.com/wp-content/uploads/2008/07/neanderthaler2.jpg 400w" sizes="auto, (max-width: 300px) 100vw, 300px" />
<h6>Quality</h6>
Breathtaking in its quality her genome tells us a little about her,   but more importantly it gives us a better understanding of human evolution.
By comparing her data with other sequence data, researchers have been able to show that there was intermixing not just between modern humans and Neanderthals, but between Neanderthals, Denisovans (another ancient human), modern humans and perhaps other as yet unknown groups of ancient humans.
Using the sequence and comparing it to other Neanderthal, Denisovan and modern human genomes, the researchers – which included scientists from UC Berkeley, MIT, Harvard, the University of Washington and the Chinese Academy of Sciences in Beijing – were able to illustrate how genes flowed between these populations.
<h6>The Period of Intermixing</h6>
While there was interbreeding between Neanderthals, Denisovans and modern humans, there is still a distinct genetic difference between them.
As Carl Zimmer<a href="https://www.nytimes.com/2013/12/19/science/toe-fossil-provides-complete-neanderthal-genome.html?pagewanted=2&amp;ref=science"> reported</a> in The New York Times, they “did not become one big genetic blur.”
After the periods of intermixing Denisovan and Neanderthals gradually disappeared, but their DNA remains in most modern humans.
The genome sequence – which is of a quality comparable to that of a sequence one could get from a modern human – offered researchers other insights including that ancient woman’s parents were likely related – perhaps half-siblings – and that her ancestors also likely inbred.
The findings lend support for a more nuanced story of human evolution.
<h6>Much to Learn</h6>
Earlier this year researchers 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 surprised researchers.
The age of the bone, and its location, lead them to believe they would find Neanderthal DNA. It turned out to be Denisovan. Previous finds placed the Denisovans farther east and only back as far as 80,000 years.
Clearly there is still much to learn about how all these pieces fit together with our own evolutionary history.
&#8211; <a href="https://blog.23andme.com/articles/our-neanderthal-cousins/" target="_blank" rel="noopener">Our Neanderthal Cousins</a>
&#8211; <a href="https://blog.23andme.com/articles/more-fun-with-neanderthals/">More Fun with Neanderthals</a>
&#8211;<a href="https://blog.23andme.com/articles/new-evidence-suggests-interbreeding-between-humans-and-neanderthals/"> New Evidence Suggests Humans and Neanderthal Interbreeding</a>
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<img loading="lazy" decoding="async" class="alignright wp-image-14049" title="neanderthal icon" src="https://blog-api.23andme.com/wp-content/uploads/2012/06/neanderthal-icon-96x150.jpg" alt="" width="50" height="77" />
Got Neanderthal DNA?
23andMe customers can <a href="https://www.23andme.com/you/labs/neanderthal/">find their inner Neanderthal</a> or at least how much Neanderthal DNA they have. Not yet a customer? <a href="https://www.23andme.com/store">Visit our store</a>!
</div>

Neanderthals Genome Sheds Light On Human Evolution

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

23andMe will soon be genotyping customers with a newly designed custom microarray chip.<img loading="lazy" decoding="async" class="alignright wp-image-6586 size-medium" src="http://35.88.189.111/wp-content/uploads/2010/05/23andMe_Logo_blog-300x300.jpg" alt="an image of 23andMe's logo" 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" />
The new version – along with completion of additional lab space – will ultimately improve both the efficiency and speed by which we will be able to process samples and then return genetic data to our customers.
<h6>Custom Chip</h6>
Unlike previous changes to our chip, this new version, dubbed v4, consists of a fully custom panel of probes for detecting <a href="https://www.23andme.com/gen101/snps/" target="_blank" rel="noopener">single nucleotide polymorphisms (SNPs)</a> selected by our researchers. The selection was made to maximize the number of actionable health and ancestry features available to customers as well as offer flexibility for future research. 
Unlike previous changes to our chips, this one will not significantly alter what is reported to customers, so there would be little reason to retest on the latest platform.
The new chip includes both common variants that provide genome-wide coverage and <a href="//" target="_blank" rel="noopener">rare variants.</a> Rare variants are found in certain medically relevant genes and exons. Researchers also ensured that the chip covers SNPs with known disease associations. In addition the chip has variants that are known to be involved with drug metabolism and side effects.
<h6>The New V-4 Chip</h6>
In addition, v4 includes SNPs that our researchers use to <a href="https://www.23andme.com/ancestry/techniques/" target="_blank" rel="noopener">assign genetic ancestry.</a> They use autosomal DNA markers as well as variants in both mitochondrial DNA and in the Y chromosome. The custom chip will also allow our researchers to better impute many variants present on larger chips. Imputation is a powerful statistical method allowing researchers to fill in missing data.
Researchers use publicly available full-sequence data and 23andMe&#8217;s own data to impute the genotype at specific locations.
The new chip was designed to be compatible with all our current features. However there may be some small differences in some reports. 23andMe will inform our customers of those differences in community posts.
If you haven&#8217;t seen it already, the video below fills you in on how a sample is processed at the lab.
<iframe loading="lazy" title="23andMe DNA Processing Lab Video" width="500" height="281" src="https://www.youtube.com/embed/Enn3BHE3v4s?feature=oembed" frameborder="0" allow="accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share" referrerpolicy="strict-origin-when-cross-origin" allowfullscreen></iframe>

23andMe’s New Custom Chip

In a flurry of appearances over the course of a few days earlier this month, 23andMe’s CEO Anne Wojcicki articulated again the role personal genetics will play in health care, and what it might mean to have not just a million people genotyped, but millions.<img loading="lazy" decoding="async" class="alignright wp-image-19715 size-medium" src="http://35.88.189.111/wp-content/uploads/2013/11/Most-Daring-CEO-300x175.jpg" alt="" width="300" height="175" srcset="https://blogcms.23andme.com/wp-content/uploads/2013/11/Most-Daring-CEO-300x175.jpg 300w, https://blogcms.23andme.com/wp-content/uploads/2013/11/Most-Daring-CEO-768x447.jpg 768w, https://blogcms.23andme.com/wp-content/uploads/2013/11/Most-Daring-CEO-1024x597.jpg 1024w, https://blogcms.23andme.com/wp-content/uploads/2013/11/Most-Daring-CEO-880x513.jpg 880w, https://blogcms.23andme.com/wp-content/uploads/2013/11/Most-Daring-CEO-1180x687.jpg 1180w, https://blogcms.23andme.com/wp-content/uploads/2013/11/Most-Daring-CEO.jpg 1629w" sizes="auto, (max-width: 300px) 100vw, 300px" />
“A million people walking around with their genomes, I believe, is going to be disruptive to the health care system,” she said on <a href="https://blog.23andme.com/news/23andmes-daring-ceo-on-cbs/">CBS This Morning last Thursday</a>.
That disruption is a good thing, she said. By giving people access to their genetic information and insight into their own health, individuals – with the advice of their their doctors – can take more informed measures in keeping themselves healthy. That’s a change to a system that traditionally waits until someone is sick to take action, Anne said.
On the Fox Business program The Willis Report, Anne – along with Emily Drabant Conley, PhD, 23andMe’s business development manager – explained how offering people access to their personal genetic information will help give them “a roadmap” for better health. This can  alert individuals to their risks for disease and focus them and their physicians on the best plan for prevention.
Anne talked about this again on <a href="http://video.cnbc.com/gallery/?video=3000215804">CNBC’s On The Money with Maria Bartiromo</a>, where the host said the $99 test, “makes health and access to the data much more democratic.”
A day before her appearance on CBS, Anne said something similar at the<a href="https://www.fastcompany.com/3021310/most-creative-people/fixing-healthcaregov-is-the-least-of-it-when-it-comes-to-fixing-health-"> Innovation Uncensored conference</a>, hosted by Fast Company.
Empowering patients with their 23andMe results can help individuals prevent disease by alerting them to a risk beforehand. And, she said, health care reform – with its emphasis on controlling costs and prevention – will also push this change.
&#8220;Healthcare reform will mean we&#8217;re all more invested in keeping people healthy,&#8221; she said.
Beyond that, 23andMe’s   model also has the power to transform research. By leveraging the power of the Internet, 23andMe’s model enlists individuals in the research process. It offers people a chance to participate, and help in research they believe is important, while also giving them something in return – access to their own results.  This has sped up the research, and helped create communities focused on certain diseases. The data 23andMe gathers is also a resource for researchers, or as <a href="http://dealbook.nytimes.com/2013/11/11/for-99-eliminating-the-mystery-of-pandoras-genetic-box/?_r=1">she said to The New York Times</a>:
“We’re creating a resource for humanity and we don’t want to be the only ones who are getting access to it. As many people as possible should get access to that data,” she said.
Having a million people genotyped, or millions of people, also offers a huge opportunity to gain more insight into not just the genetics behind disease, but the genetics of good health.
&#8220;There&#8217;s a power in having big data,” she said.

News — Page 22