23andMe

23andMe Holding Co.
Company type	Public (formerly)
Industry	Personal genomics, Biotechnology
Founded	2006; 20 years ago
Founder	Linda Avey, Paul Cusenza, Anne Wojcicki
Fate	Filed for Chapter 11 bankruptcy in March 2025; acquired by TTAM Research Institute in June 2025
Successor	TTAM Research Institute (owner as of June 2025)
Headquarters	South San Francisco, California, United States
Area served	United States, Canada, United Kingdom
Key people	Anne Wojcicki (former CEO), Joe Selsavage (interim CEO as of March 2025)
Products	Direct-to-consumer genetic testing services including ancestry and health risk reports
Owner	TTAM Research Institute (as of June 2025)
Number of employees	582 (2024)
Website	www.23andme.com

23andMe Holding Co. is a U.S.-based company specializing in personal genomics and biotechnology, with its headquarters located in South San Francisco, California. It provides direct-to-consumer genetic testing by analyzing saliva samples through single nucleotide polymorphism genotyping, delivering insights into ancestry and genetic health risks. The company’s name is derived from the 23 chromosome pairs present in human cells.

Established in 2006 by entrepreneurs Linda Avey, Paul Cusenza, and Anne Wojcicki, 23andMe was a pioneer in autosomal DNA ancestry testing, a technique that has since become an industry standard. Its saliva-based genetic test earned recognition as Time magazine’s "Invention of the Year" in 2008.

The firm encountered regulatory hurdles with the U.S. Food and Drug Administration (FDA) concerning its health-related genetic testing services; however, it resumed these offerings in the United States by October 2015 following FDA clearance. The company broadened its market reach by launching services in Canada and the United Kingdom during 2014.

In 2021, 23andMe went public through a merger with a Special Purpose Acquisition Company (SPAC), initially achieving a market valuation of $6 billion. By 2024, this valuation had dramatically declined to merely 2% of its peak value. In March 2025, facing financial distress, the company filed for Chapter 11 bankruptcy protection, which coincided with CEO Anne Wojcicki’s resignation. This development raised concerns about the confidentiality of sensitive customer genetic data, prompting a consumer warning issued by the California Attorney General.

In May 2025, Regeneron Pharmaceuticals agreed to purchase 23andMe out of bankruptcy for $256 million. However, in June 2025, TTAM Research Institute—a nonprofit organization founded by Wojcicki—submitted a superior bid of $305 million and acquired ownership.

As of 2024, the company employed 582 individuals and reported revenues of $192 million while sustaining operating losses exceeding $680 million. Its core business revolves around direct-to-consumer genetic tests and related services that include ancestry profiling, health risk assessments, and collaborations in medical research. Executive leadership has concentrated on regulatory compliance, international expansion, and managing financial performance amid intense industry competition.

History

23andMe was launched in 2006 by Linda Avey, Paul Cusenza, and Anne Wojcicki to offer genetic testing paired with interpretive services. Early investor materials revealed intentions to create a genetic database for research purposes. In 2007, Google led a $3.9 million funding round alongside Genentech, New Enterprise Associates, and Mohr Davidow Ventures; notably, Wojcicki was married to Google co-founder Sergey Brin at that time. Cusenza departed the company in 2007, followed by Avey in 2009.

By 2012, the firm had secured $50 million during its Series D financing round, nearly doubling total capital raised to $52.6 million. A subsequent Series E round in 2015 generated $115 million, bringing cumulative funding to $241 million. In 2017, it raised an additional $250 million at a valuation of $1.75 billion; prior to this round, total capital raised amounted to $230 million.

In July 2018, 23andMe entered into a strategic partnership with pharmaceutical leader GlaxoSmithKline (GSK), granting GSK access to data from five million customers for drug discovery efforts; GSK invested $300 million initially and extended the collaboration in 2022 with an added $50 million commitment.

Originally headquartered in Mountain View, California, the company relocated to larger facilities in Sunnyvale in 2019. In January 2020, it reduced its workforce by approximately 100 employees amid declining sales of consumer genetic tests.

The collaboration with GSK culminated in a joint clinical trial for cancer therapies announced in July 2020. Later that year, 23andMe raised roughly $82.5 million during its Series F funding round, pushing total funding beyond $850 million.

In February 2021, the company agreed to merge with Sir Richard Branson's SPAC VG Acquisition Corp in a transaction valued at $3.5 billion and subsequently debuted on Nasdaq under ticker "ME" in June 2021.

October 2021 saw the acquisition of telehealth provider Lemonaid Health for $400 million, marking an expansion into virtual healthcare services.

Following its initial public offering peak valuation of $6 billion, the company’s value sharply declined by 2024 due to ongoing unprofitability and reliance on one-time DNA kit purchases rather than recurring revenue streams. CEO Wojcicki attempted multiple times between 2024 and early 2025 to privatize the business but was rebuffed by the board.

In September 2024 all seven independent board members resigned amid strategic disagreements. The company declared it would no longer entertain acquisition proposals from third parties. Data privacy concerns emerged as users requested deletion of their genetic information; however, policies mandate data retention for three years before removal can occur.

After layoffs in November 2024 and announcements of liquidity constraints in January 2025, management explored strategic alternatives including potential sale options. On March 23, 2025, Chapter 11 bankruptcy protection was filed while plans were made for asset disposition. CEO Wojcicki resigned and CFO Joe Selsavage assumed interim CEO duties. Trading was halted and shares were delisted from Nasdaq by the end of March.

During bankruptcy proceedings, California’s Attorney General issued alerts regarding consumer privacy protections related to genetic information. Regeneron Pharmaceuticals won the bankruptcy auction with a bid of $256 million to acquire most assets excluding Lemonaid Health; this acquisition was anticipated to finalize in Q3 2025. The company also intended to deregister as a publicly traded entity by June.

In June 2025 Anne Wojcicki’s nonprofit TTAM Research Institute outbid Regeneron with a $305 million offer to regain control of 23andMe along with its data assets.

Direct-to-consumer genetic testing

23andMe introduced its direct-to-consumer genetic testing service in November 2007, providing customers with a saliva collection kit for partial single nucleotide polymorphism (SNP) analysis, with results accessible online. By 2008, the company was delivering risk estimates for more than 90 traits and conditions, earning the distinction of Time magazine's "Invention of the Year."

The testing procedure entails extracting and amplifying DNA from saliva samples, which are then applied to a microarray chip containing gene probes designed to identify variants associated with diseases such as Parkinson's, celiac disease, and Alzheimer's. Customers receive detailed reports outlining these genetic variants. Additionally, users can download their raw genetic information to examine specific chromosomes and mitochondrial DNA. Tests related to ancestry provide genealogical tools and access to databases for identifying genetic relatives. In the United States, customers who purchased health-related tests before November 2013 could access assessments of inherited traits and disease risks; however, health report offerings were paused for regulatory review until late 2015. In Canada and the UK, access to health-related results remains limited.

By February 2018, over three million people had been genotyped through the service, though FDA-imposed marketing limitations slowed user growth. As of February 2024, the company reported having genotyped in excess of 14 million individuals.

The platform has become a popular resource among donor-conceived individuals searching for biological siblings or donors, underscoring its significant role in personal genomics and family connections.

Product changes

Towards the end of 2009, 23andMe divided its genotyping services into three distinct products—Ancestry Edition, Health Edition, and Complete Edition—each with different pricing structures. This segmentation was reversed approximately a year later when the products were recombined into a single offering. In late 2010, the company introduced a monthly subscription model to provide ongoing updates reflecting new medical research findings; however, this approach was met with limited acceptance and was discontinued by mid-2012.

Between November 2013 and October 2015, due to FDA restrictions, 23andMe in the US offered only raw genetic data and ancestry information without health-related interpretations. Following FDA approval in October 2015, health-related reports were reinstated.

The price for full direct-to-consumer testing in the US decreased from $999 at launch in 2007 to $399 in 2008, then further dropped to $99 by 2012—effectively serving as a loss leader aimed at expanding the customer database. In October 2015, pricing increased to $199. By September 2016, an ancestry-only test was available for $99 with an option to upgrade for an additional $125 to include health reports.

Internationally, the service launched in Canada in October 2014 at CAD 99 and in the UK in December 2014 at £125; both versions included health-related results.

In February 2018, the company enhanced its ancestry reports by increasing geographic resolution from broad regions to specific countries, adding coverage of 120 new regions. To improve representation of Asian and African populations in its database, it initiated programs such as the African Genetics Program (2016) and Global Genetics Program (2018), which offer complimentary testing to individuals with heritage from targeted countries. The Populations Collaboration Program also formed partnerships with researchers focusing on underrepresented regions to broaden genomic data diversity.

Supplementary offerings

Beginning October 1, 2020, the company introduced "23andMe+," a subscription priced at $29 annually, available to "Health + Ancestry" users utilizing the fifth generation microarray chip. This subscription delivers enhanced health and pharmacogenetic insights, along with continuous updates and added functionalities.

Acquisition of Lemonaid Health

Towards the end of 2021, 23andMe expanded its digital healthcare capabilities by acquiring Lemonaid Health for $400 million. This strategic move aimed to improve access for both patients and healthcare providers to vital health risk assessments and treatment data. Following the acquisition, Paul Johnson, Lemonaid’s CEO and co-founder, assumed the role of COO for 23andMe’s consumer division.

Versions of instruments and chips

Prior to 2010, instruments produced by Illumina were marketed solely "for research use only." Early in that year, Illumina obtained FDA authorization for its BeadXpress platform to be utilized in clinical diagnostics.

Regulatory environment in the United States

The growth of genetic testing services has prompted concerns regarding the interpretation of results and the potential for genetic discrimination. Regulatory frameworks remain in development, with risk-based oversight models for genetic tests still pending full implementation.

State-level regulation

In 2008, regulatory authorities in New York and California informed 23andMe and similar firms that possessing a Clinical Laboratory Improvement Amendments (CLIA) certification was mandatory to offer testing services within those states. By August of that year, 23andMe had secured the necessary CLIA licenses to operate legally in California.

FDA involvement

Since 2008, 23andMe has been in ongoing discussions with the FDA about regulatory compliance. In 2010, the FDA designated genetic tests as medical devices requiring federal approval, affecting companies such as 23andMe and Illumina. Subsequently, 23andMe submitted applications seeking FDA clearance in 2012.

In November 2013, after a six-month period without communication from 23andMe, the FDA directed the company to stop marketing its personal genome service (PGS), citing insufficient analytical and clinical validation and public health risks due to potentially inaccurate results. As a result, 23andMe halted promotion of PGS but continued to sell it, restricting offerings to raw genetic data and ancestry information by December 2013.

CEO Anne Wojcicki recognized these regulatory obstacles and stressed collaboration with the FDA to develop industry standards. By the end of 2013, health-related genetic testing was suspended for new customers pending further regulatory review.

In 2014, aiming to expand internationally, 23andMe pursued market entry into Canada, Australia, and the UK. Full genetic testing services were launched in Canada and the UK by late that year.

During that same year, the company filed a 510(k) submission for a Bloom syndrome carrier test that demonstrated accuracy and ease of sample collection. The FDA approved this test in February 2015 and indicated no additional submissions would be necessary for comparable carrier tests. Further regulatory clarifications were provided in October 2015.

On October 21, 2015, 23andMe recommenced marketing carrier screening tests within the United States. Wojcicki noted previous misunderstandings regarding FDA and CMS regulatory requirements.

Following this, 23andMe submitted a de novo application covering tests assessing genetic predisposition for various diseases. In April 2017, the FDA authorized ten such tests addressing conditions including late-onset Alzheimer’s disease, Parkinson’s disease, celiac disease, hereditary thrombophilia, among others. The FDA emphasized these approvals relate solely to genetic risk information rather than diagnostic purposes and suggested future exemptions might apply to similar tests.

In March 2018, the FDA granted approval for a direct-to-consumer test targeting three specific BRCA mutations common among Ashkenazi Jewish populations. Although this test does not cover all BRCA mutations comprehensively, it provides valuable information regarding elevated risks for breast, ovarian, and prostate cancers.

COVID-19

In June 2020, 23andMe released research suggesting that individuals with type O blood might experience a 9–18% reduced likelihood of contracting COVID-19, based on information gathered from more than 750,000 participants. Additionally, those exposed to the virus were found to be 13–26% less likely to receive a positive test result. This study was formally published in April 2021 within Nature Genetics. Later investigations by the company explored genetic associations with COVID-19 symptoms, vaccine responses, ethnic disparities, and factors contributing to long COVID, with results shared at the 2023 ASHG meeting.

Informed consent and privacy concerns

Since 2013, scrutiny has arisen over whether 23andMe secures adequate informed consent through its online DNA testing platform. The firm collects not only genetic and personal data from users but also behavioral information via its website, software applications, cookies, and mobile app. Its privacy policy permits the utilization of this information for aggregated data analysis and targeted marketing efforts, making it an asset for external entities such as health insurers, pharmaceutical companies, biotechnology firms, and advertisers.

Ongoing worries relate to how well customers understand the extent of data usage and the risks of potential data breaches. Under current policies, user data may be accessed, sold, or transferred, prompting significant privacy and ethical debates regarding the company's operational model.

United States

While 23andMe must adhere to various state privacy regulations, it is exempt from HIPAA since it does not function as a healthcare provider. Studies reveal that most consumers rarely read the terms and conditions thoroughly, raising questions about the adequacy of informed consent concerning data handling. Nonetheless, the company's consent process has received institutional review board approval. Its privacy policy authorizes sharing data with third parties under multiple provisions:

Section 4(b): Enables third-party advertising networks to gather web activity data for targeted advertising.

Section 4(c): Allows aggregated user data to be shared with research collaborators regardless of individual consent.

Section 4(d): Permits sharing personal information within subsidiaries or affiliated companies to improve services and user experience.

The Genetic Information Nondiscrimination Act (GINA) offers protection against genetic discrimination by employers and health insurers in most contexts but does not cover long-term care or disability insurance.

European Union

Starting on 25 May 2018, 23andMe complies with the General Data Protection Regulation (GDPR), which regulates the processing, use, and storage of personal data for EU residents. GDPR also applies to businesses providing goods or services to individuals in the EU, reinforcing stringent data protection standards and enhancing user control over their personal information.

Medical research

More than 80% of 23andMe users agree to have their data utilized for research purposes. The company examines aggregated customer datasets to investigate hereditary diseases and licenses access to pharmaceutical and biotech organizations. Collaborations also extend to academic institutions and government researchers. In July 2012, 23andMe acquired CureTogether—a crowdsourced platform for treatment ratings covering over 600 medical conditions—thereby broadening its research capabilities. Users may opt-in to allow their genetic data to be included in published studies; however, some genetic and self-reported information may still be shared with third-party service providers even without explicit consent.

In 2010, 23andMe confirmed NIH discoveries linking mutations in the glucocerebrosidase gene to Parkinson’s disease. By 2015, under leadership from former Genentech executive Richard Scheller, the company pivoted toward drug discovery efforts targeting Parkinson’s disease through its genetic database. Partnerships were also formed with Pfizer to investigate genetic factors behind inflammatory bowel diseases such as ulcerative colitis and Crohn’s disease.

In 2016, due to concerns that complex sequencing results conflicted with the company’s mission of providing straightforward consumer insights, 23andMe halted a next-generation sequencing project. That same year, using self-reported customer information, it identified seventeen genetic loci associated with depression.

By 2017, collaborations expanded with pharmaceutical firm Lundbeck and the Milken Institute focusing on psychiatric illnesses including bipolar disorder and major depression. These efforts aimed at uncovering genetic underpinnings and developing targeted therapeutics. This strategic move into drug development highlights 23andMe’s ongoing transformation toward leveraging its comprehensive genetic repository for pharmaceutical innovation.

Law Enforcement Usage

According to 23andMe's transparency report released in September 2024, the company has received requests from law enforcement authorities concerning data on 15 users within the United States since 2015. No such data requests have originated from other countries. Importantly, no user account information was disclosed in response to these inquiries. The company's Privacy Policy emphasizes that personal data is only shared with law enforcement when accompanied by a valid court order, subpoena, or search warrant.

Data Breach of 2023

In October 2023, 23andMe suffered a significant security breach impacting the sensitive details of around seven million users, roughly half of its total clientele. The compromised information encompassed users' names, addresses, and genetic data, which was subsequently offered for sale on the internet. The breach was attributed to a credential stuffing attack focusing on individuals who had activated the "DNA Relatives" feature, with particular impact on users of Ashkenazi Jewish and Chinese heritage.

In June 2025, the UK's Information Commissioner’s Office imposed a fine of £2.31 million on 23andMe due to insufficient security protocols and a delayed reaction to the incident. Regulatory authorities criticized the company for vulnerabilities including the absence of multi-factor authentication and inadequate threat detection systems that permitted unauthorized access to critical genetic and personal user information.

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