23andMe
   HOME

TheInfoList



OR:

23andMe Holding Co. is an American personal genomics and
biotechnology Biotechnology is a multidisciplinary field that involves the integration of natural sciences and Engineering Science, engineering sciences in order to achieve the application of organisms and parts thereof for products and services. Specialists ...
company based in
South San Francisco, California South San Francisco is a city in San Mateo County, California, United States, on the San Francisco Peninsula in the San Francisco Bay Area. The city is colloquially termed "South City". The population was 66,105 at the 2020 United States censu ...
. It is best known for providing a direct-to-consumer genetic testing service in which customers provide a saliva sample that is laboratory analysed, using single nucleotide polymorphism genotyping, to generate reports relating to the customer's ancestry and genetic predispositions to health-related topics. The company's name is derived from the 23 pairs of
chromosome A chromosome is a package of DNA containing part or all of the genetic material of an organism. In most chromosomes, the very long thin DNA fibers are coated with nucleosome-forming packaging proteins; in eukaryotic cells, the most import ...
s in a
diploid Ploidy () is the number of complete sets of chromosomes in a cell, and hence the number of possible alleles for autosomal and pseudoautosomal genes. Here ''sets of chromosomes'' refers to the number of maternal and paternal chromosome copies, ...
human cell. Founded in 2006, 23andMe soon became the first company to begin offering
autosomal An autosome is any chromosome that is not a sex chromosome. The members of an autosome pair in a diploid cell have the same morphology, unlike those in allosomal (sex chromosome) pairs, which may have different structures. The DNA in autosome ...
DNA testing for ancestry, which all other major companies now use. Its saliva-based direct-to-consumer genetic testing business was named "Invention of the Year" by ''
Time Time is the continuous progression of existence that occurs in an apparently irreversible process, irreversible succession from the past, through the present, and into the future. It is a component quantity of various measurements used to sequ ...
'' in 2008. The company had a previously fraught relationship with the United States
Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...
(FDA) due to its genetic health tests; as of October 2015, DNA tests ordered in the US include a revised health component, per FDA approval. 23andMe has been selling a product with both ancestry and health-related components in Canada since October 2014, and in the UK since December 2014. 23andMe became a publicly traded company in 2021, via a merger with a Special Purpose Acquisition Company (SPAC), and soon had a market capitalization of US$6 billion. By 2024, its valuation had fallen to 2% of that peak. In March 2025, 23andMe filed for
Chapter 11 bankruptcy Chapter 11 of the United States Bankruptcy Code ( Title 11 of the United States Code) permits reorganization under the bankruptcy laws of the United States. Such reorganization, known as Chapter 11 bankruptcy, is available to every business, w ...
, and CEO
Anne Wojcicki Anne E. Wojcicki ( ; born July 28, 1973) is an American entrepreneur. She is known for co-founding the personal genomics company 23andMe. Early life and education Wojcicki was born in Palo Alto, California, the youngest of three sisters: Susan W ...
resigned. Due to the sensitive nature of data stored by 23andMe and privacy concerns due to bankruptcy filing, the attorney general of California subsequently issued a consumer alert for its customers. On May 19, 2025, Regeneron agreed to buy 23andMe out of bankruptcy for $256 million. In June 2025, TTAM Research Institute, a non-profit founded by Anne Wojcicki, outbid Regeneron and won the bid for 23andMe for $305 million.


History

Linda Avey Linda Avey (née Bahnson) is an American biologist and entrepreneur. She is known for co-founding 23andMe, a consumer genetic data company. Early life Avey was born Linda Bahnson in 1960, in South Dakota, United States. She attended Augustan ...
, Paul Cusenza, and Anne Wojcicki founded 23andMe in 2006 to offer
genetic testing Genetic testing, also known as DNA testing, is used to identify changes in DNA sequence or chromosome structure. Genetic testing can also include measuring the results of genetic changes, such as RNA analysis as an output of gene expression, or ...
and interpretation to individuals. Investment documents from 2007 also suggest that 23andMe hoped to develop a database to pursue research efforts. In 2007,
Google Google LLC (, ) is an American multinational corporation and technology company focusing on online advertising, search engine technology, cloud computing, computer software, quantum computing, e-commerce, consumer electronics, and artificial ...
invested $3.9 million in the company, along with
Genentech Genentech, Inc. is an American biotechnology corporation headquartered in South San Francisco, California. It operates as an independent subsidiary of holding company Roche. Genentech Research and Early Development operates as an independent cent ...
,
New Enterprise Associates New Enterprise Associates (NEA) is an American-based venture capital firm. NEA focuses investment stages ranging from seed stage through growth stage across an array of industry sectors. With over $25 billion in committed capital, NEA is one of t ...
, and Mohr Davidow Ventures. Wojcicki and Google co-founder
Sergey Brin Sergey Mikhailovich Brin (; born August 21, 1973) is an American computer scientist and businessman who co-founded Google with Larry Page. He was the president of Google's parent company, Alphabet Inc., until stepping down from the role on D ...
were married at the time. Cusenza left the company in 2007 and Avey left in 2009. In 2012, 23andMe raised $50 million in a Series D
venture round A venture round is a type of funding round used for venture capital financing, by which startup company, startup companies obtain investment, generally from venture capitalists and other institutional investors. The availability of venture fundi ...
, almost doubling its capital of $52.6 million. In 2015, 23andMe raised $115 million in a Series E offering, increasing capital to $241 million. In September 2017, it was rumored the company was raising another $200 million with a $1.5 billion valuation. As of that time, the company had raised $230 million since its inception. Afterwards, it was reported the company raised $250 million, at a $1.75 billion valuation. On July 25, 2018, 23andMe announced a partnership with
GlaxoSmithKline GSK plc (an acronym from its former name GlaxoSmithKline plc) is a British Multinational corporation, multinational Pharmaceutics, pharmaceutical and biotechnology company with headquarters in London. It was established in 2000 by a Mergers an ...
to allow the pharmaceutical company to use test results from 5 million customers to design new drugs. GlaxoSmithKline invested $300 million in the company. In January 2022, this partnership was extended until July 2023 with an additional $50 million payment from GlaxoSmithKline. The company was based in
Mountain View, California Mountain View is a city in Santa Clara County, California, United States, part of the San Francisco Bay Area. Named for its views of the Santa Cruz Mountains, the population was 82,376 at the 2020 United States census, 2020 census. Mountain V ...
, initially in North Bayshore and then downtown, until 2019, when it moved to a larger headquarters in Sunnyvale. In January 2020, 23andMe announced it would lay off about 100 employees in its consumer testing division. In July 2020, 23andMe and GlaxoSmithKline announced their partnership's first clinical trial: a joint asset being co-developed by the two companies for cancer treatment. In December 2020, the company raised around $82.5 million in a series F round, bringing the total raised over the years to over $850M. The post-money valuation was not reported. In February 2021, the company announced that it had entered into a definitive agreement to merge with Sir
Richard Branson Sir Richard Charles Nicholas Branson (born 18 July 1950) is an English business magnate who co-founded the Virgin Group in 1970, and controlled 5 companies remaining of once more than 400. Branson expressed his desire to become an entrepreneu ...
's
special-purpose acquisition company A special-purpose acquisition company (SPAC; ), also known as a blank check company or a blind-pool stock offering, is a shell corporation listed on a stock exchange with the purpose of acquiring (or merging with) a private company, thus taking ...
, VG Acquisition Corp, in a $3.5 billion transaction. In June 2021, the company completed the merger with VG Acquisition Corp. The combined company was renamed to 23andMe Holding Co. and began trading on the
Nasdaq The Nasdaq Stock Market (; National Association of Securities Dealers Automated Quotations) is an American stock exchange based in New York City. It is the most active stock trading venue in the U.S. by volume, and ranked second on the list ...
stock exchange on June 17, 2021, under the ticker symbol "ME". In October 2021, 23andMe announced that it would acquire Lemonaid Health, a
telehealth Telehealth is the distribution of Health care, health-related services and information via electronic information and telecommunications, telecommunication technologies. It allows long-distance patient and clinician contact, care, advice, reminde ...
company, for $400 million with the deal closing in November. After 23andMe became a publicly traded company in 2021, it reached a market capitalization of $6 billion. By 2024, its valuation had fallen to 2% of that peak. Suggested factors include the fact that the company has never been profitable, with lack of recurring revenue from 23andMe's retail customers of its DNA kits (who only need to take the test once). In an attempt to regain control, Wojcicki made an initial bid in February 2024 to take 23andMe private, offering $2.53 per share in a joint bid, but it did not proceed. In July 2024, Wojcicki offered 40 cents each for all outstanding shares not already owned by her directly or through affiliates. The proposal was rejected by a committee set up to evaluate options for the company's future, and in September the seven independent members of the board of directors all resigned. The company subsequently filed with the SEC indicating that it was no longer open to third-party acquisition offers. Users were concerned about the security of their genetic data, and were trying to delete it from the company's archives only to find out that it holds onto the data for three years before deleting to comply with "legal obligations". The company conducted layoffs in November 2024. In January 2025, 23andMe declared that it would need additional liquidity to fund operations, and was actively exploring strategic alternatives including a potential sale of the company. Wojcicki made a third offer of 41 cents per share in March 2025. On March 23, 2025, 23andMe filed for
Chapter 11 bankruptcy Chapter 11 of the United States Bankruptcy Code ( Title 11 of the United States Code) permits reorganization under the bankruptcy laws of the United States. Such reorganization, known as Chapter 11 bankruptcy, is available to every business, w ...
protection in
Delaware Delaware ( ) is a U.S. state, state in the Mid-Atlantic (United States), Mid-Atlantic and South Atlantic states, South Atlantic regions of the United States. It borders Maryland to its south and west, Pennsylvania to its north, New Jersey ...
as part of a plan to sell its assets. The company listed assets and liabilities between $100 million and $500 million. Anne Wojcicki announced that she would be stepping down from her role as CEO, and would be replaced with CFO Joe Selsavage. Trading for company's shares was suspended on March 31 and stock was subsequently delisted from
Nasdaq The Nasdaq Stock Market (; National Association of Securities Dealers Automated Quotations) is an American stock exchange based in New York City. It is the most active stock trading venue in the U.S. by volume, and ranked second on the list ...
and commenced trading
over-the-counter Over-the-counter (OTC) drugs are medicines sold directly to a consumer without a requirement for a prescription from a healthcare professional, as opposed to prescription drugs, which may be supplied only to consumers possessing a valid pres ...
. California Attorney General Rob Bonta issued a privacy consumer alert reminding Californian users of their right to request deletion of their genetic data. The company said there would not be any changes to the way it protects consumer data while in bankruptcy court. The bankruptcy auction was won by Regeneron Pharmaceuticals who agreed to buy the firm for $256 million. As part of the agreement, Regeneron would acquire all units of 23andMe except its on-demand telehealth service Lemonaid Health, and 23andMe would operate as a wholly owned unit of Regeneron. The transaction was expected to be completed in the third quarter of 2025. Following the acquisition, 23andMe announced that it would cease being a public company and deregister from the SEC effective June 6, 2025. In June 2025, TTAM Research Institute, a non-profit founded by Anne Wojcicki, outbid Regeneron and won the bid for 23andMe for $305 million.


Products


Direct-to-consumer genetic testing

23andMe began offering direct-to-consumer genetic testing in November 2007. Customers provide a
saliva testing Saliva testing or Salivaomics is a medical test, diagnostic technique that involves laboratory analysis of saliva to identify markers of endocrine disorders, endocrine, immunology, immunologic, inflammatory disease, inflammatory, infectious dise ...
sample that is partially single nucleotide polymorphism (SNP) genotyped and results are posted online. In 2008, when the company was offering estimates of "predisposition for more than 90 traits and conditions ranging from baldness to blindness", ''Time'' magazine named the product "Invention of the Year". After the sample is received by the lab, the DNA is extracted from the saliva and amplified so that there is enough to be
genotype The genotype of an organism is its complete set of genetic material. Genotype can also be used to refer to the alleles or variants an individual carries in a particular gene or genetic location. The number of alleles an individual can have in a ...
d. The DNA is then cut into small pieces, and applied to a glass microarray chip, which has many microscopic beads applied to its surface. Each bead has a gene probe on it that matches the DNA of one of the many variants the company test for. If the sample has a match in the microarray, the sequences will hybridize, or bind together, letting researchers know that this variant is present in the customer's genome by a fluorescent label located on the probes. Tens of thousands of variants are tested out of the 10 to 30 million located in the entire genome. These matches are then compiled into a report that is supplied to the customer, allowing them to know if the variants associated with certain diseases, such as Parkinson's, celiac and Alzheimer's, are present in their own genome. Uninterpreted raw genetic data may be downloaded by customers. This provides customers with the ability to choose one of the 23 chromosomes, as well as
mitochondrial DNA Mitochondrial DNA (mtDNA and mDNA) is the DNA located in the mitochondrion, mitochondria organelles in a eukaryotic cell that converts chemical energy from food into adenosine triphosphate (ATP). Mitochondrial DNA is a small portion of the D ...
, and see which base is located in certain positions in
gene In biology, the word gene has two meanings. The Mendelian gene is a basic unit of heredity. The molecular gene is a sequence of nucleotides in DNA that is transcribed to produce a functional RNA. There are two types of molecular genes: protei ...
s, and see how these compare to other common variants. Customers who bought tests with an ancestry-related component have online access to
genealogical DNA test A genealogical DNA test is a DNA-based Genetic testing, genetic test used in genetic genealogy that looks at specific locations of a person's genome in order to find or verify ancestral genealogical relationships, or (with lower reliability) to ...
results and tools, including a relative-matching database. Customers can also view their mitochondrial haplogroup (maternal) and, if they are male or a relative shared a patriline that has also been tested, Y chromosome haplogroup (paternal). US customers who bought tests with a health-related component and received health-related results before November 22, 2013, have online access to an assessment of inherited traits and
genetic disorder A genetic disorder is a health problem caused by one or more abnormalities in the genome. It can be caused by a mutation in a single gene (monogenic) or multiple genes (polygenic) or by a chromosome abnormality. Although polygenic disorders ...
risks. Health-related results for US customers who purchased the test from November 22, 2013, were suspended until late 2015 while undergoing an FDA regulatory review. Customers who bought tests from 23andMe's Canadian and UK locations have access to some, but not all, health-related results. As of February 2018, 23andMe has genotyped over 3,000,000 individuals. FDA marketing restrictions reduced customer growth rates. In February 2024, 23andMe said they had genotyped more than 14,000,000 individuals. 23andMe is commonly used for donor conceived people to find their biological siblings and in some cases their
sperm Sperm (: sperm or sperms) is the male reproductive Cell (biology), cell, or gamete, in anisogamous forms of sexual reproduction (forms in which there is a larger, female reproductive cell and a smaller, male one). Animals produce motile sperm ...
or egg donor.


Product changes

In late 2009, 23andMe split its genotyping service into three products with different prices: an Ancestry Edition, a Health edition, and a Complete Edition. This decision was reversed a year later, when the different products were recombined. In late 2010, the company introduced a monthly subscription fee for updates based on new
medical research Medical research (or biomedical research), also known as health research, refers to the process of using scientific methods with the aim to produce knowledge about human diseases, the prevention and treatment of illness, and the promotion of ...
findings. The subscription model proved unpopular with customers and was eliminated in mid-2012. 23andMe only sold raw genetic data and ancestry-related results in the US due to FDA restrictions from November 22, 2013, until October 21, 2015, when it announced that it would resume providing health information in the form of carrier status and wellness reports with FDA approval. The price of the full direct-to-consumer testing service in the US reduced from $999 in 2007 to $399 in 2008 and to $99 in 2012, and was effectively being sold as a
loss leader A loss leader (also leader) is a pricing strategy where a product is sold at a price below its market cost to stimulate other sales of more profitable goods or services. With this sales promotion/marketing strategy, a "leader" is any popular artic ...
in order to build a valuable customer database. In October 2015, the US price was raised to $199. In September 2016, an ancestry-only version was once again offered at a lower price of $99 with an option to upgrade to include the health component for an additional $125 later. The initial price of the product sold in Canada from October 2014, which includes health-related results, was . The initial price of the product sold in the UK from December 2014, which includes health-related results, was £125. In February 2018, 23andMe announced that its ancestry reporting would tell people what country they were from, not just what region, and increased the number of regions by 120. Like other companies, it still lacked data about Asia and Africa, which the African Genetics Program (launched in October 2016 with a grant from the US
National Institutes of Health The National Institutes of Health (NIH) is the primary agency of the United States government responsible for biomedical and public health research. It was founded in 1887 and is part of the United States Department of Health and Human Service ...
) will rectify by recruiting
sub-Saharan Africa Sub-Saharan Africa is the area and regions of the continent of Africa that lie south of the Sahara. These include Central Africa, East Africa, Southern Africa, and West Africa. Geopolitically, in addition to the list of sovereign states and ...
ns to increase the genomic data on racial and ethnic minorities. Building off of the African Genetics Program, the Global Genetics Program was also announced in February 2018. This program aims to increase the genomic data of 61 underrepresented countries in their database by providing free tests to individuals that have all 4 grandparents from one of the countries. In April 2018, 23andMe announced the Populations Collaboration Program, which sets up formal collaborations between the company and researchers that are investigating underrepresented countries.


Additional services

Since October 1, 2020, the company has offered a new service called "23andMe+", priced at $29/year, for the customers of the "Health + Ancestry" service, who completed genotyping on version 5 of the microarray chip used by the company. The new service makes available additional reports on health and pharmacogenetics, and commits to provide ongoing new reports and features.


Lemonaid Health acquisition

At the end of 2021, 23andMe acquired leading digital healthcare company Lemonaid Health for $400m to "...give patients and healthcare providers better information about health risks and treatment". Paul Johnson, CEO and co-founder of Lemonaid Health became COO of the 23andMe consumer business.


Instrument and chip versions

Up until 2010, Illumina only sold instruments that were labeled "for research use only"; in early 2010, Illumina obtained FDA approval for its BeadXpress system to be used in clinical tests.


Government regulation in the United States

The new genetic testing service and ability to map significant portions of the
genome A genome is all the genetic information of an organism. It consists of nucleotide sequences of DNA (or RNA in RNA viruses). The nuclear genome includes protein-coding genes and non-coding genes, other functional regions of the genome such as ...
has raised controversial questions, including whether the results can be interpreted meaningfully and whether they will lead to
genetic discrimination Genetic discrimination occurs when people treat others (or are treated) differently because they have or are perceived to have a gene mutation(s) that causes or increases the risk of an inherited disorder. It may also refer to any and all discr ...
. The regulatory environment for genetic testing companies has been uncertain, and anticipated risk-based regulation for different types of genetic tests has not yet materialized.


State regulators

In 2008, New York and
California California () is a U.S. state, state in the Western United States that lies on the West Coast of the United States, Pacific Coast. It borders Oregon to the north, Nevada and Arizona to the east, and shares Mexico–United States border, an ...
each provided notice to 23andMe and similar companies that those companies needed to obtain a CLIA license in order to sell tests in those states. By August 2008, 23andMe had received licenses that allow them to continue to do business in California.


FDA

According to
Anne Wojcicki Anne E. Wojcicki ( ; born July 28, 1973) is an American entrepreneur. She is known for co-founding the personal genomics company 23andMe. Early life and education Wojcicki was born in Palo Alto, California, the youngest of three sisters: Susan W ...
, 23andMe has been in dialogue with the FDA since 2008. In 2010, the FDA notified several genetic testing companies, including 23andMe, that their genetic tests are considered
medical device A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assura ...
s and federal approval is required to market them; a similar letter was sent to Illumina, which makes the instruments and chips used by 23andMe in providing its service. 23andMe first submitted applications for FDA clearance in July and September 2012. In November 2013, the FDA published guidance on how it classified genetic analysis and testing services offered by companies using instruments and chips labelled for "research use only" and instruments and chips that had been approved for clinical use. At around the same time, after not hearing from 23andMe for six months, the FDA ordered 23andMe to stop marketing its saliva collection kit and personal genome service (PGS), as 23andMe had not demonstrated that they have "analytically or clinically validated the PGS for its intended uses" and that the "FDA is concerned about the public health consequences of inaccurate results from the PGS device". , 23andMe had stopped all advertisements for its PGS test but is still selling the product. , 23andMe was selling only raw genetic data and ancestry-related results. 23andMe publicly responded to media reports on November 25, 2013, stating, "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." CEO Anne Wojcicki subsequently posted an update on the 23andMe website, stating: "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." On December 5, 2013, 23andMe announced that it had suspended health-related genetic tests for customers who purchased the test from November 22, 2013, in order to comply with the FDA warning letter, while undergoing regulatory review. In May 2014, it was reported that 23andMe was exploring alternative locations abroad, including Canada, Australia, and the United Kingdom, in which to offer its full genetic testing service. 23andMe had been selling a product with both ancestry and health-related components in Canada since October 2014, and in the UK since December 2014. In 2014, 23andMe submitted a 510(k) application to the FDA to market a carrier test for Bloom syndrome, which included data showing that 23andme's results were consistent and reliable and that the saliva collection kit and instructions were easy enough for people to use without making mistakes that might affect their results, and included citations to the
scientific literature Scientific literature encompasses a vast body of academic papers that spans various disciplines within the natural and social sciences. It primarily consists of academic papers that present original empirical research and theoretical ...
showing that the specific tests that 23andMe offered were associated with Blooms. The FDA cleared the test in February 2015; in the clearance notice, the FDA said that it would not require similar applications for other carrier tests from 23andMe. The FDA sent further clarification about regulation of the test to 23andMe on October 1, 2015. On October 21, 2015, 23andMe announced that it would begin marketing carrier tests in the US again. Wojcicki said, "There was part of us that didn’t understand how the regulatory environment works" in regards to the distributed laboratory regulatory functions of FDA and Centers for Medicare and Medicaid Service (CMS). 23andMe submitted a " de novo" application to the FDA to market tests that provide people with information about whether they have
gene mutation In biology, a mutation is an alteration in the nucleic acid sequence of the genome of an organism, virus, or extrachromosomal DNA. Viral genomes contain either DNA or RNA. Mutations result from errors during DNA or viral replication, mitosis ...
s or
allele An allele is a variant of the sequence of nucleotides at a particular location, or Locus (genetics), locus, on a DNA molecule. Alleles can differ at a single position through Single-nucleotide polymorphism, single nucleotide polymorphisms (SNP), ...
s that put them at risk for getting or having certain diseases; the applications included data showing that 23andMe's results were consistent and reliable. In April 2017, the FDA approved the applications for ten tests: late-onset
Alzheimer's disease Alzheimer's disease (AD) is a neurodegenerative disease and the cause of 60–70% of cases of dementia. The most common early symptom is difficulty in remembering recent events. As the disease advances, symptoms can include problems wit ...
,
Parkinson's disease Parkinson's disease (PD), or simply Parkinson's, is a neurodegenerative disease primarily of the central nervous system, affecting both motor system, motor and non-motor systems. Symptoms typically develop gradually and non-motor issues become ...
,
celiac disease Coeliac disease (British English) or celiac disease (American English) is a long-term autoimmune disorder, primarily affecting the small intestine. Patients develop intolerance to gluten, which is present in foods such as wheat, rye, spel ...
, hereditary thrombophilia,
alpha-1 antitrypsin deficiency Alpha-1 antitrypsin deficiency (A1AD or AATD) is a genetic disorder that may result in lung disease or liver disease. Onset of lung problems is typically between 20 and 50 years of age. This may result in shortness of breath, wheezing, or an inc ...
,
glucose-6-phosphate dehydrogenase deficiency Glucose-6-phosphate dehydrogenase deficiency (G6PDD), also known as favism, is the most common enzyme deficiency anemia worldwide. It is an inborn error of metabolism that predisposes to red blood cell breakdown. Most of the time, those who ar ...
, early-onset of
dystonia Dystonia is a neurology, neurological Hyperkinesia, hyperkinetic Movement disorders, movement disorder in which sustained or repetitive muscle contractions occur involuntarily, resulting in twisting and repetitive movements or abnormal fixed po ...
, factor XI deficiency, and
Gaucher's disease Gaucher's disease or Gaucher disease () (GD) is a genetic disorder in which glucocerebroside (a sphingolipid, also known as glucosylceramide) accumulates in cells and certain organs. The disorder is characterized by bruising, fatigue, anemia, low ...
. The FDA also said that it intended to exempt further 23andMe genetic risk tests from the needing 510(k) applications, and it clarified that it was only approving genetic risk tests, not
diagnostic tests A medical test is a medical procedure performed to detect, diagnose, or monitor diseases, disease processes, susceptibility, or to determine a course of treatment. Medical tests such as, physical and visual exams, diagnostic imaging, genetic t ...
. In March 2018, the FDA approved another ''de novo'' application from the company, this one for a
direct-to-consumer Direct-to-consumer (DTC or D2C) or business-to-consumer (B2C) is the business model of selling products directly to customers and thereby bypassing any third-party retailers, wholesalers, or middlemen. Direct-to-consumer sales are usually transa ...
test for three specific ''BRCA'' mutations that are the most common ''BRCA'' mutations in people of Ashkenazi descent; they are not however the most common ''BRCA'' mutations in the general population, and the test is only for three of the approximately 1,000 known mutations. These mutations increase the risk of
breast The breasts are two prominences located on the upper ventral region of the torso among humans and other primates. Both sexes develop breasts from the same embryology, embryological tissues. The relative size and development of the breasts is ...
and
ovarian cancer Ovarian cancer is a cancerous tumor of an ovary. It may originate from the ovary itself or more commonly from communicating nearby structures such as fallopian tubes or the inner lining of the abdomen. The ovary is made up of three different ...
in women, and the risk of breast and
prostate cancer Prostate cancer is the neoplasm, uncontrolled growth of cells in the prostate, a gland in the male reproductive system below the bladder. Abnormal growth of the prostate tissue is usually detected through Screening (medicine), screening tests, ...
in men.


COVID-19

In June 2020, 23andMe published results from a study that claimed that people with type O blood may be at lower risk of catching COVID-19. Out of more than 750,000 participants, those with type O blood were 9–18% less likely to contract the virus, while those who had been exposed were 13–26% less likely to test positive. The study was published in April 2021 in
Nature Genetics ''Nature Genetics'' is a peer-reviewed scientific journal published by Nature Portfolio. It was established in 1992. It covers research in genetics. The chief editor is Tiago Faial. The journal encompasses genetic and functional genomic studies ...
. Subsequent research focused on examining genetic associations with COVID-19 symptoms such as loss of taste or smell, vaccine reactions and its impact across different ethnicities, and risk factors of
long COVID Long may refer to: Measurement * Long, characteristic of something of great duration * Long, characteristic of something of great length * Longitude (abbreviation: long.), a geographic coordinate * Longa (music), note value in early music mens ...
. Findings from their long COVID research was presented in 2023 ASHG conference.


Informed consent and privacy concerns

Questions have been raised since at least 2013 as to whether the company can obtain
informed consent Informed consent is an applied ethics principle that a person must have sufficient information and understanding before making decisions about accepting risk. Pertinent information may include risks and benefits of treatments, alternative treatme ...
through its web-based interactions with people who want to submit samples for
sequencing In genetics and biochemistry, sequencing means to determine the primary structure (sometimes incorrectly called the primary sequence) of an unbranched biopolymer. Sequencing results in a symbolic linear depiction known as a sequence which succ ...
. The company collects not only genetic and personal information from customers who order DNA tests, but also data about other web behavior information that 23andMe captures through the use of its website, products, software,
cookies A cookie is a sweet biscuit with high sugar and fat content. Cookie dough is softer than that used for other types of biscuit, and they are cooked longer at lower temperatures. The dough typically contains flour, sugar, egg, and some type of ...
, and through its smartphone app. A combination of several individual policies within the terms of service and privacy policy (cookies, disclosure of aggregate data, targeted advertising) makes 23andMe a valuable data mine for third parties such as
health insurance companies Health insurance or medical insurance (also known as medical aid in South Africa) is a type of insurance that covers the whole or a part of the risk of a person incurring medical expenses. As with other types of insurance, risk is shared among ma ...
,
pharmaceutical companies The pharmaceutical industry is a Medicine, medical industry that discovers, develops, produces, and markets pharmaceutical goods such as medications and medical devices. Medications are then administered to (or Self-medicate, self-administered b ...
, advertising companies, biotechnology companies, law enforcement, or other interested parties. People may not actually be aware of how the company uses the data, and there are always risks of
data breach A data breach, also known as data leakage, is "the unauthorized exposure, disclosure, or loss of personal information". Attackers have a variety of motives, from financial gain to political activism, political repression, and espionage. There ...
es. Personal information of customers of 23andMe “may be accessed, sold or transferred”.


United States

Depending on which state an individual resides in, 23andMe must follow that state's laws regarding privacy and disclosing information. Since 23andMe is not a medical provider, the company does not have to abide by standard privacy policies that must be followed at a doctor's office, such as the
Health Insurance Portability and Accountability Act The Health Insurance Portability and Accountability Act of 1996 (HIPAA or the Ted Kennedy, Kennedy–Nancy Kassebaum, Kassebaum Act) is a United States Act of Congress enacted by the 104th United States Congress and signed into law by President ...
(HIPAA). Research by Deloitte has shown that only 9% of consumers actually read the terms and conditions, and research from ProPrivacy concluded that only 1% of consumers read the policies, which suggests that consent to be included in research may have been given without full knowledge of the permissions being given. In addition, 23andMe's privacy policy can be confusing for consumers to understand. Despite confusion, 23andMe's informed consent practices are approved by an
institutional review board An institutional review board (IRB), also known as an independent ethics committee (IEC), ethical review board (ERB), or research ethics board (REB), is a committee at an institution that applies research ethics by reviewing the methods proposed ...
. Several sections of the privacy policy allows data to be disclosed to third parties, regardless whether the consent is signed:
Section 4(b) "We permit third party advertising networks and providers to collect Web-Behavior Information regarding the use of our Services to help us to deliver targeted online advertisements ('ads') to you."
Section 4(c): "Regardless of your consent status, we may also include your data in aggregate data that we disclose to third-party research partners who will not publish that information in a scientific journal."
Section 4(d): "We may share some or all of your Personal Information with other companies under common ownership or control of 23andMe, which may include our subsidiaries, our corporate parent, or any other subsidiaries owned by our corporate parent in order to provide you better service and improve user experience."
The
Genetic Information Nondiscrimination Act The Genetic Information Nondiscrimination Act of 2008 (, GINA ), is an Act of Congress in the United States designed to prohibit some types of genetic discrimination. The act bars the use of genetic information in health insurance and employm ...
(GINA) protects a person against discrimination based on genetic information by their employer(s) or insurance companies in ''most'' situations. However, GINA does not extend to discrimination based on genetic information for long-term care or disability-insurance providers.


European Union

Effective 25 May 2018, 23andMe must abide by the
General Data Protection Regulation The General Data Protection Regulation (Regulation (EU) 2016/679), abbreviated GDPR, is a European Union regulation on information privacy in the European Union (EU) and the European Economic Area (EEA). The GDPR is an important component of ...
(GDPR). The GDPR is a set of rules/regulations that helps an individual take control of their data information that is collected, used and stored digitally or in a structured filing system on paper, and restricts a company's use of personal data. The regulation also applies to companies who offer the company's products/services outside of the EU.


Medical research

Over 80% of 23andMe customers have opted in to having their data used in research. Aggregated customer data is studied by scientific researchers employed by 23andMe for research on inherited disorders; rights to use customers' data is also sold to
pharmaceutical Medication (also called medicament, medicine, pharmaceutical drug, medicinal product, medicinal drug or simply drug) is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy ( pharmacotherapy) is an important part of the ...
and
biotechnology Biotechnology is a multidisciplinary field that involves the integration of natural sciences and Engineering Science, engineering sciences in order to achieve the application of organisms and parts thereof for products and services. Specialists ...
companies for use in their research. The company also collaborates with academic and government scientists. In July 2012, 23andMe acquired the startup CureTogether, a crowdsourced treatment ratings website with data on over 600 medical conditions. 23andMe has an optional consent that enables the individual's genetic information to be included in medical research that may be published in a scientific journal. However, if an individual chooses not to consent for their 'personal information' to be used, their 'genetic information' and 'self-reported information' may still be used and shared with the company's third party service providers. In 2010, 23andMe said that it was able to use its database to validate work published by the NIH: identifying mutations in the gene that codes for glucocerebrosidase as a risk factor for Parkinson's disease. In 2015, 23andMe made a business decision to pursue
drug discovery In the fields of medicine, biotechnology, and pharmacology, drug discovery is the process by which new candidate medications are discovered. Historically, drugs were discovered by identifying the active ingredient from traditional remedies or ...
themselves, under the direction of former
Genentech Genentech, Inc. is an American biotechnology corporation headquartered in South San Francisco, California. It operates as an independent subsidiary of holding company Roche. Genentech Research and Early Development operates as an independent cent ...
executive
Richard Scheller Richard H. Scheller (born 30 October 1953) is the former chief science officer and head of therapeutics at 23andMe and the former executive vice president of research and early development at Genentech. He was a professor at Stanford University f ...
. One of their main focuses is Parkinson's disease, and they are utilizing the 23andMe database to search for rare variants associated with Parkinson's in the hope of developing a drug for the disease. The company also set up research agreements with the pharmaceutical company
Pfizer Pfizer Inc. ( ) is an American Multinational corporation, multinational Pharmaceutical industry, pharmaceutical and biotechnology corporation headquartered at The Spiral (New York City), The Spiral in Manhattan, New York City. Founded in 184 ...
to explore the genetic causes of
inflammatory bowel disease Inflammatory bowel disease (IBD) is a group of inflammatory conditions of the colon and small intestine, with Crohn's disease and ulcerative colitis (UC) being the principal types. Crohn's disease affects the small intestine and large intestine ...
, namely
ulcerative colitis Ulcerative colitis (UC) is one of the two types of inflammatory bowel disease (IBD), with the other type being Crohn's disease. It is a long-term condition that results in inflammation and ulcers of the colon and rectum. The primary sympto ...
and
Crohn's disease Crohn's disease is a type of inflammatory bowel disease (IBD) that may affect any segment of the gastrointestinal tract. Symptoms often include abdominal pain, diarrhea, fever, abdominal distension, and weight loss. Complications outside of the ...
. In 2016, a project that the company was developing to provide customers with next generation sequencing was ended, because of the fear that the results would be too complicated or vague to fit into the company's goal of providing useful information, both quickly and precisely, directly to consumers, according to Wojcicki. Also in 2016, 23andMe used self-reported data from customers to locate 17 genetic loci that seem to be associated with depression. In 2017, 23andMe, the
Lundbeck H. Lundbeck A/S, commonly referred to as Lundbeck, is a Denmark, Danish international pharmaceutical company engaged in the research, development, manufacturing, marketing and sale of pharmaceuticals across the world. The company’s products ar ...
pharmaceutical company, and the
Milken Institute The Milken Institute is an independent economic think tank based in Santa Monica, California, with offices in Washington, D.C., New York, Miami, London, Abu Dhabi, and Singapore. It publishes research and hosts conferences that apply market-bas ...
think tank started collaborations to focus on psychiatric disorders, such as
bipolar disorder Bipolar disorder (BD), previously known as manic depression, is a mental disorder characterized by periods of Depression (mood), depression and periods of abnormally elevated Mood (psychology), mood that each last from days to weeks, and in ...
and
major depression Major depressive disorder (MDD), also known as clinical depression, is a mental disorder characterized by at least two weeks of pervasive low mood, low self-esteem, and loss of interest or pleasure in normally enjoyable activities. Intro ...
. Their goals are to determine the genetic roots of such disorders, as well as pursue drug discovery in those areas.


Use by law enforcement

23andMe's transparency report states that they had received requests from law enforcement for 15 US users' data since 2015 as of September 2024, and none from other countries. Data Produced (By User Account) was zero. The 23andMe Privacy Policy states that customers "can rest assured, we will not voluntarily share your Personal Information with... Law enforcement, absent a valid court order, subpoena, or search warrant".


2023 data breach

In October 2023, a significant data breach occurred and sensitive information of 23AndMe users was stolen. Hackers stole 7 million people's data, about half of 23andMe's customers at the time. Stolen information included people's names, addresses and genetic data and was sold online. In June 2025, the UK’s Information Commissioner’s Office (ICO) fined 23andMe £2.31 million for failing to protect user data, citing inadequate security measures and a slow response to the 2023 breach. Regulators criticised the company for weak security practices, including the lack of multi-factor authentication and inadequate monitoring of threats, which allowed hackers to access sensitive genetic and personal information. The company claimed that it was a
credential stuffing Credential stuffing is a type of cyberattack in which the attacker collects stolen account credentials, typically consisting of lists of usernames or email addresses and the corresponding passwords (often from a data breach), and then uses the cr ...
incident rather than a breach into their systems. The hackers targeted
Ashkenazi Jews Ashkenazi Jews ( ; also known as Ashkenazic Jews or Ashkenazim) form a distinct subgroup of the Jewish diaspora, that emerged in the Holy Roman Empire around the end of the first millennium CE. They traditionally speak Yiddish, a language ...
and users of Chinese descent and are attempting to sell the stolen information. The affected accounts had enabled the platform's "DNA Relatives" feature, which helps users find genetic relatives and connect with each other.


See also

*
Genographic Project The Genographic Project, launched on 13 April 2005 by the National Geographic Society and IBM, was a Molecular anthropology, genetic anthropological study (sales discontinued on 31 May 2019) that aimed to map historical human migrations patter ...
*
Biobank A biobank is a type of biorepository that stores biological samples (usually human) for use in research. Biobanks have become an important resource in medical research, supporting many types of contemporary research like genomics and personalized ...


References


Further reading


23andMe’s New Formula: Patient Consent
Antonio Regalado, ''
MIT Technology Review ''MIT Technology Review'' is a bimonthly magazine wholly owned by the Massachusetts Institute of Technology. It was founded in 1899 as ''The Technology Review'', and was re-launched without "''The''" in its name on April 23, 1998, under then pu ...
''


External links

* {{DEFAULTSORT:23andme Genetic genealogy companies Applied genetics American companies established in 2006 Biotechnology companies of the United States Companies based in South San Francisco, California Technology companies based in the San Francisco Bay Area Biotechnology companies established in 2006 2006 establishments in California American genealogy websites Genetics databases GV companies Special-purpose acquisition companies Companies listed on the Nasdaq Privacy controversies Companies that filed for Chapter 11 bankruptcy in 2025