23andMe's Bankruptcy, Is Your Data For Sale? The Risks of Consumer Biotech

23andMe, the California biotech company with almost 2 decades of genetic info from 15 million customers, has filed for bankruptcy 3/23/2205.  A combination of data breaches, a disastrous stock crash, and a failed subscription model has seen the company slash its workforce and slowly close its doors. 23andMe provided consumers the ability to "sequence their genome" and find out interesting information about themselves both trivial and medically serious. This data can be personal to the consumer or even damning if it falls into the wrong hands. 

The question now going around is whether or not this data is at risk of being sold to the highest bidder, despite there not being many in line to buy at the moment. 23andMe assures that it will ensure the law is carried out to protect its data, but the reality is that there is not much regarding biotech companies like itself. HIPAA may be the first thing that comes to mind, which is a law that protects the disclosure of health information without the patient's consent. However, HIPAA does not cover direct-to-consumer products such as 23andMe, meaning the the answer is complicated as to whether or not their data will be protected. There are some states with laws which may pertain to this kind of genetic info, but the most do not have any regulation, this is not even to mention how it may be dealt with in countries outside of the US. As 23andMe navigates bankruptcy users are still able to view and delete their data, but there is no doubt all 15 million of its customers will know to remove their sensitive information before the company's tech potentially changes hands. 

Sources: 

https://www.cnbc.com/2025/04/17/23andme-bankruptcy-investigation-genetic-data-congress.html

https://www.npr.org/2025/03/24/nx-s1-5338622/23andme-bankruptcy-genetic-data-privacy

Variability with polygenic risk scores

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    With increased popularity in companies such as 23andme and the ability to assess a person's DNA for a "polygenic risk scores", preventative health decisions are becoming more and more popular. The polygenic risk score is basically an overall assessment of an individuals DNA using a small piece of DNA from saliva and generate an estimation based on large-scale genomic studies. While a large majority of the consumers can be accurately assessed for risk, other users may find themselves in the wrong category. This has lead to a study to be conducted, in which coronary heart disease, atrial fibrillation, type 2 diabetes, Alzheimer's disease, glaucoma, and breast cancer, were used in order to calculate risk scores. The data had shown that regardless of what control is used for the risk factor, due to the scale of population-level genetics, there is always introduced variability. In order to reduce this randomness the researchers had to run the tool multiple times to eliminate the random elements and create an average to assist in a computational process that strives for accuracy. 
    Based on the information provided by the article, it has created a sense of yes and no debate with regards to these polygenic tests. Essentially the information is saying that the more they sequence the snippet of DNA the more the results are accurate. The question is how many times are these companies actually doing these sequences as well as how radical are these overall results? Of course this research is evidentially useful to those who are prone to these risks, but if the inaccuracies are substantial in certain groups is the information really that useful on a global scale? It is all interesting regardless, just more curious in terms of information that is actually gathered by these tests versus what is generally assumed by the test itself based on these population level pools.

https://medicalxpress.com/news/2020-12-highlights-strategies-boosting-accuracy-personal.html

https://genomemedicine.biomedcentral.com/articles/10.1186/s13073-020-00801-x

World's Largest Family Tree!

At-home genetic testing kits like AncestryDNA and 23andMe have become increasingly popular.  Geni.com is another heritage mapping company with over 130 million family tree connections worldwide.  Using these profiles, researchers were able to link 13 million people, possibly creating the world’s largest family tree.  How creepy is that?!

article: https://www.smithsonianmag.com/smart-news/worlds-largest-family-tree-stretches-back-five-centuries-180968334/

related article: https://www.sciencemag.org/news/2018/03/thirteen-million-degrees-kevin-bacon-world-s-largest-family-tree-shines-light-life-span

Same Sex Attraction Genetics

Same Sex Attraction Genetics

        One of the most debated discussions of this generation is same-sex marriage and attraction. Many questions have been asked about this topic which have been unable to be answered such as why do same sex attraction continue through generations and does this mean less procreation. Andrea Ganna, a geneticist at the Broad Institute, has spoken about the soon to be published study that may shed light on the topic explaining scientifically why people of the same sex are attracted to each other. She insisted that there is no single gene this is based on and the studies are no on sexual orientation but on non-heterosexual behavior. There were about 500,000 men and women who's genes were surveyed. The data came from two sources. The DNA of just over 400,000 participants was from the British government's UK Biobank. Researchers found four variants that were linked to the people that had same sex encounters. When these variants showed in men, they tended to have a significantly larger amount of lifetime partners, and showed to be more physically attractive, although this is subjective. Four regions were identified, two in men and women, and two in only men. Once of these genes was in the olfactory receptor which is not surprising as smell has previously been linked to attraction.

     While this education is important as is the research, people are still worried about the possible effects it may have. This could include the eradication of same sex people, by eliminating the genes or changing them. This may also lead to an increase in abortions if people can find out whether or not their child will be more prone to being non-heterosexuals.

     I am excited for this type of research to continue because this is something we do not have a lot of knowledge on yet and have a lot to learn. While I do look forward to a scientific reason for same-sex attraction, I do share the worries as many others for the possible loss of time to come. If people are given the chance, they may not want to accept their children, and this would only cause for more hate of same-sex couples and people with same-sex attraction. I fear for more hatred but always have an inner urge for more knowledge, making this a difficult position. I look forward for more information and to the research to be published.

Link to article; https://www.statnews.com/2018/10/24/genetics-same-sex-attraction/

Similar article; https://www.sciencemag.org/news/2018/10/giant-study-links-dna-variants-same-sex-behavior

First Home Testing Kit for Breast Cancer Mutations

The FDA has granted a genetic testing company the rights to distribute an at-home saliva test in order to determine one’s risk for three breast cancer gene mutations. 23andMe now offers these screenings as part of their Health and Ancestry product listed at $199. These saliva samples also provide individuals with ancestral history on their country of origin, as well as the genetic health risks that are involved in said areas. The test takes approximately two weeks to be analyzed and have a return of the results. Women are at an extremely higher risk of developing breast and ovarian cancer if they test positive for one of the BRCA1 and BRCA2 gene mutations. Men are also at a higher risk if they possess one of these genes, however it is much more uncommon for men to develop breast cancer (however not impossible). These mutations however, may lead to a higher risk of prostate cancer in men. Clients need to be aware; because if the at-home test states that you are negative for the gene mutations, it does NOT mean that you can’t get breast/ovarian cancer, since there are over 1,000 mutations associated with the BRCA gene. The Ashkenazi Jews (a derivative of Judaism of central Europe) are more likely to test positive for all three gene mutations than any other ethnical group. Donald St. Pierre of the FDA states that, “The test provides information to certain individuals who may be at increased breast, ovarian or prostate cancer risk and who might not otherwise get genetic screening, and is a step forward in the availability of direct-to-consumer genetic tests…this test should not be used as a substitute for seeing your doctor for cancer screenings or counseling on genetic and lifestyle factors that increase or decrease cancer risk”.

23andMe had originally reported these gene mutations back in 2010 without being approved by the FDA, however the FDA has issued them a warning in 2013. This caused the company to stop providing all health data until the FDA had reproducible results, and was proven statistically significant. A warning label is also not made mandatory on all test kits, stating that negative results do not rule out other genetic mutations associated with cancer risks, tests should not be used to determine medical treatment, tests should not be a substitute for a doctor’s visit, and that positive test results must be reviewed with their doctor in order to determine proper medical treatment. Ann Wojcicki the CEO of 23andMe, said that this product was made available due to high public demand.

This article was interesting to say the least.  It is nice for people with a background history of breast cancer to may find a a little piece of mind if they are positive or negative for these gene mutations, however I do not know about the quality of these tests.  $199 seems a little to good to be true to me, and since it is a newer product, I am not sure if I would trust the results or not.  I would personally stick to testing done through a licensed physician, or through a specialist with a more reputable product.

(Link to article)
(Related Article)

Genetics, Inc.

What is genetics? A science, or a business? In a recent article in CNBC, it suggests the latter. Amazon has recently began selling genetics tests for companies like 23andme as well as Ancestry. Although the rapid commercialization of these types of products gave everyday people access to these resources, which is great, is it beginning to go too far?

Pop culture has began propagating that genetics is be be-all, end-all to disease and disorders people face today. And while genetics does have a strong role in our health and bodies, it is not the complete picture. Companies like 23andme, as well as Ancestry have capitalized off this new field. While their products may have some validity, they should not be purchased for anything more than entertainment value. The question is this: will commercialization of these products draw money away from valuable research, and place it into something that can earn money? Would investors rather place research money in a company that'll promise to sells tones of products, or in a company that only promises to do research on genetics, and may or may not make any money back?

In today's world, people go where the money is. And I fear the day where genetics become a business more than a science.

A Possible New Hope is On the Horizon For Those With Mental Illness

Through genetics many traits are passed down both physically and mentally; categorizing depression and bipolar disorder as a gene that can be inherited is not as far fetch as some many believe. A study on whether these disorders can be found in ones genes will be conducted by a genetics company 23 and Me along with assistance from Milken Institute and company for pharmaceuticals known as Lundbeck. These companies hope to acquire data from 15,000 people with depressive disorder and 10,000 people with bipolar disorder, all who have been medically diagnosed. To be looked at other than just the genetic aspect of the person will be their cognitive reaction through completing a total of 9 surveys online that will be given monthly. For the researchers to gather data on possible phenotypes that could cause these disorders, each person involved with submit a swab of salvia that will be studied. These companies understand that all cases of each disorder may not be from genetics since it is known already that many are due to environmental factors but looking into the possible cause in genetic reasoning could be groundbreaking still. From this project the researchers hope to be able to come up with potential therapies that could help people who suffer from these disorders. The companies are readying the necessary requirements for this project and currently are looking for applicants that would like to use information on their disorder to possibly help others going through the same hardships in the future.

FDA Approves at Home DNA Test for 10 Diseases

     

http://www.npr.org/sections/health-shots/2017/04/07/522897473/fda-approves-marketing-of-consumer-genetic-tests-for-some-conditions

http://time.com/4729600/fda-approval-23andme-dna-tests/

       The FDA has finally approved its very first at home genetic testing kit from the company 23andMe. 23andMe have attempted at home genetic testing kits in the past, however they were stopped due to inaccurate results and other complications. This kit is said to help test for 10 different diseases which includes Parkinson's, Late-onset Alzheimer's, Celiac disease, Alpha-1 antitrypsin deficiency, Early-onset primary dystonia, Factor XI deficiency, Gaucher disease type 1, Glucose- 6 phosphate dehydrogenase deficiency, Hereditary hemochromatosis, and Hereditary thrombophilia. 

      This at home kit is a great way for people to find out the answers they want while in the comfort of their own home. However, it is being stressed to consumers that this not the ultimate final answer. Genetics are not the only factor when it comes to diseases. The environment, lifestyle choices, and diet are just a few different factors that play a large role in determining whether or not a person will get a disease. 

       After hearing the news about this kit, the National Institute on Aging has stated that it is very unlikely for genetic testing to ever predict with accuracy Alzheimer's disease since there are multiple factors that lead to the progression of it. There is a positive outlook for this at home testing kit and the hopes for more kits for different diseases in the near future. 

Genetic Mutation Testing Now Made Public

23andMe is just one of the many companies that use a consumers DNA to report to them their ancestry and heritage. The above picture is the device a consumer spits in and sends away to the company. Now the company wants to use the DNA in order to provide consumers with do-it-yourself diagnostic testing. At first, this service was stopped by the FDA in 2013 because they feared consumers would use the information to make real life medical decisions. The FDA finally allowed 23andMe to tell consumers “whether they possess genetic mutations (Maxmen, 2017)” that are known to cause certain medical conditions. Some of the conditions include Parkinson’s, Alzheimer’s, coeliac and thrombophilia. The downsides of this service include consumers reading these results without the help of a genetic counselor or doctor. 

Nature.com Article

23andMe

F.D.A. Will Allow 23andMe to Sell Genetic Tests for Disease Risk to Consumers

      A company named 2andMe based in Mountain View, California has long sought the green light to sell consumers genetic tests. The Food and Drug Administration is allowing the company 23andMe to sell genetic test kits to consumers, this will allow them to test for the likelihood that they will inherit genetic diseases such  as Alzheimer's. Currently the companies test only include ten diseases including Parkinson , Celiac disease, Alzheimer's, Gaucher disease type 1, etc.  This landmark decision for the FDA is expected to allow more companies to release tests directly to the consumer. The health kit sold by 23andMe is retailed for $199.00 and is a simple process.

   

    After a customer purchases the kit they then spit into a tube and mail it o the 23andMe headquarters. The companies lab will extract DNA from the saliva and test it against genetic markers for certain diseases. The customer can then log into their account and see the report and its interpretation. Although i believe this is a big step in allowing the public to readily know if they are carrying a disease, i also find man drawbacks. Most who have a family history of illness may want to know right away if they too inherited the disease and with the new technology can know in a matter of days without properly preparing themselves mentally for the news. Once you have received the results there is no unknowing and that could lead to depression. Also the tests could confuse customers as the results do not indicate you have the disease but that you have a higher likelihood.

https://www.nytimes.com/2017/04/06/health/fda-genetic-tests-23andme.html?_r=0

https://techcrunch.com/2017/04/06/23andme-is-finally-allowed-to-tell-you-if-you-have-the-genes-for-parkinsons/

https://www.23andme.com

Recent Research Suggests a Genetic Link to Depression

In recent years, it has been identified that major depressive disorder is a very noteworthy disease and health problem. However, its biological infrastructure is not well understood. This is due to the diseases heritability and its variability in the symptoms. Nature Genetics posted a recent study that pinpointed four separate genome regions with five independent gene variants that are linked to depression. The meta-analysis of data collected within this study was collected by both previous studies published about depression as well as the consumer genetics company 23andMe. These studies help to pinpoint the specific regions of the chromosome that have been commonly linked to depression. Although there is not enough research yet to prove this, a correlation can suggest an explanation. One of the most important genes to be associated with depression was OFLM4 (a protein that boosts tumor growth) which is usually expressed in the temporal lobe and the amygdala.

There was a sum of 15 independent chromosomal regions that attracted attention. Many of the associations seemed to be close to genes that encoded proteins that were involved in gene regulation. Specifically, these regulators were associated with the central nervous systems development. This means that there could absolutely be a correlation to depression. In both of the sets of data that were examined in this study, there was a link to people who had reported a self-diagnoses of depression. Overall, 17 separate locations in the genome were linked to major depression.

I find this very interesting because until recently, there has been very limited research on the origin of depression. It has been debated whether it is related to genetics or completely unrelated or both. Although this research shows a correlation between specific locations in the genome that are associated with the diagnoses of depression, there is still much to be learned about the link between genetics and depression. However, this new research gives us hope that it will provoke more studies in the future that may help to get to the bottom of the question of whether genetics are linked to depression.  

Why Are Some Patients Resistant to Genetic Diseases?

Some diseases, such as Huntington’s, sickle cell, and cystic fibrosis, are controlled by a single gene. These are called Mendelian diseases. This means that if a patient has a certain mutation on that one specific gene, that person will have the disease. However, in a recent study, researchers found a handful of people, who although they had the mutation, did not display any signs of the disease. This lead to the belief that understanding what makes these people different could help lead researchers to better treat, or even prevent, these Mendelian diseases.

In a new study, researchers analyzed 874 genes collected from over 400,000 people (all supplied by 23AndMe). Of the 874 genes, researchers focused on the 584 Mendelian conditions that set in during a patient's childhood, and compared that data to information about the patient's health.  Out of the 400,000 people analyzed, researchers discovered 13 individuals whom although had the mutation that would indicate a Mendelian disorder, they did not show any signs of the disease. However, researchers are still looking for what these 13 people have in common.

In my opinion, the most interesting/exciting thing about this article is how researchers were able to utilize the genetic information complied by 23AndMe. This is just one of many articles I have read that mentioned they utilized 23AndMe. However, one big limitation to using 23AndMe, at least in this type of study, is that researchers cannot contact any of these individuals family members, so that prevents them from being able to compile an entire genome. 

http://www.popsci.com/scientists-detect-patients-resistant-to-penetrant-genetic-diseases
http://www.nature.com/nbt/journal/vaop/ncurrent/full/nbt.3514.html

Researchers at 23andMe Determine Sleeping In Longer is Genetic

Figure 1. An adorable sleeping baby

23andMe has recently utilized their database to analyze 89,000 DNA sequences of people to determine if waking up early or sleeping in late is due to genetics. In addition to analyzing the DNA sequences, the profiles of each participant was analyzed to determine there characteristics such as sex, age, and illnesses. Through this data, the researchers have come to the conclusion that people that are female, are over 60 years old or are not suffering from insomnia are more likely to not stay up late and feel fine with waking up early. The opposite characteristics were true with people who stayed up late and slept in longer. However, this data is not 100% conclusive due to the fact that only people of European descent were studied, but it does provide substantial evidence due the vast number of participants.

I have always believed that this trait to be due to genetics, and I am not surprised that the data collected by 23andMe supports it. It would be interesting to see the if the researches would eventually be able to create better drugs to help people go to sleep and feel well rested when they wake. Or the possibility of a "Power Nap" pill where it would make a 30 minute nap equivalent to an 8 hour sleep. This would have a heavy impact on how the world worked because people would be able to work more and longer and still have many more hours in the day for family and spending the extra money they are making which would in turn boost the economy. This is a bit of a far fetched idea, but I believe we are one step closer to it with the new findings of the researchers.

Genetic Superheroes Walk Among Us, But Shhh! No One Can Tell ‘Em

http://www.wired.com/2016/04/scientists-find-genetic-superheroes-cant-tell/

A study was conducted entitled "Resilience Project" that revealed 13 people who have genetic mutations which should've ended in a deadly childhood but they survived and grew to be healthy adults. The study was published in Nature Biotechnology and they explained that in order to collect this data, they relied on genomic data that had already been collected for other studies. 400,000 genomes came from the company 23andMe; however, the scientists who conducted this study are unable to contact these people because they need consent to recontact them. For this reason, their DNA cannot be re-sequenced and studied further to find cures because they are unable to contact the people who have these genetic mutations. Many people decide not to be recontacted after consenting to allowing their DNA to be used to research because they do not what to know what other kind of complications they might have. Companies are hoping to fix this issue and have recontacting in mind before conducting research so that participants in studies can remain up-to-date with their DNA and this can therefore allow for their DNA to be re-sequenced for further research.

I think that it is unfortunate that these people cannot be contact about what the scientists found, because it is truly amazing that they were able to survive despite their serious and sometimes deadly genetic mutations. If they were actually able to contact these participants, they could potentially study their DNA further and be able to find the cures for these mutations in order to help those people who weren't so lucky with living with those diseases. Perhaps they should require recontacting if people decide to allow their DNA to be used to research, because then it's almost pointless if they're not able to conduct further research on the DNA and potentially save the lives of many. Also, if I were one of these people, I would be interested in knowing that I am a genetic "superhero" that survived such horrible mutations, but I might also not want to know about further complications I might experience later on.

I Can’t Help It, It’s In My Genes

As the old saying goes, “The early bird catches the worm.” However, some people, maybe even yourself, feel best staying up late and sleeping in vs getting up at the crack of dawn. According to a recent study published in Nature Communications, a human’s preference for early mornings or late nights might come down to the individuals genes.

This study, which was commissioned by 23andMe, utilized their massive genetic database to analyze DNA from more than 89,000 people. In addition to sending in their spit, participants of this study also answered a two-part online survey, which categorized them as morning or evening people based off their self-reporting answers. From the participants’ profiles, researchers of this study were able to make some conclusions on what they believed were characteristics that most likely lead to being a morning person. These were being a female, being over 60yrs old, having a healthy BMI, not suffering from insomnia, and being able to feel well-rested off less than 8hrs of sleep.

This study initially generated a lot of excitement because the conclusions had been drawn from a large number of humans, making the results more robust and significant. However, the population used was only European descent, which itself paints a skewed picture. In addition, self-reporting from the patients was used as well, which is notoriously known for inaccurate numbers. Regardless, the spots identified on the genome by researchers will prove to be useful for future studies.

This article was interesting because it covered a topic that is near and dear to many college students; why is it so hard to get up for 8:00am classes? It is funny to find out that it may be because of our genes. Besides when I stay up really late, I am definitely a morning person, which both my mother & father 100% are. However, since there were flawed components to the study, there is definitely room for improvement. I look forward to when scientists smooth out the bumps.

http://www.popsci.com/not-an-early-bird-blame-it-on-your-genes
http://www.nature.com/ncomms/2016/160202/ncomms10448/full/ncomms10448.html#affil-auth