23andMe Research Institute is an American personal genomics and biotechnology nonprofit public benefit company based in Palo Alto, California. It provides a direct-to-consumer genetic testing service in which customers submit a saliva sample that is laboratory analysed using single nucleotide polymorphism (SNP) genotyping to generate reports on the customer's ancestry and genetic predispositions to health-related conditions. The company's name is derived from the 23 pairs of chromosomes in a diploid human cell.[1]
Founded in 2006, 23andMe was the first company to offer autosomal DNA testing for ancestry, an approach now used across the industry.[2] Its saliva-based genetic testing service was named "Invention of the Year" by Time in 2008.[3] The company had an early confrontational relationship with the Food and Drug Administration (FDA) over its health-related tests, which were suspended in the US from late 2013 until October 2015, when the FDA began granting approvals for specific carrier status and genetic risk reports.[4][5] Products including both ancestry and health-related components have been available in Canada since October 2014[6][7][8] and in the UK since December 2014.[9]
23andMe went public in 2021 through a merger with a special-purpose acquisition company (SPAC), reaching a peak market capitalisation of approximately US$6 billion.[10] By 2024, its valuation had fallen to roughly 2% of that peak.[10] In March 2025, the company filed for Chapter 11 bankruptcy and CEO Anne Wojcicki resigned.[11] The attorney general of California issued a consumer alert due to privacy concerns surrounding the sensitive genetic data held by the company.[12][13]
Following a contested bankruptcy auction, TTAM Research Institute—a nonprofit public benefit corporation founded by Wojcicki—outbid Regeneron Pharmaceuticals and acquired substantially all of 23andMe's assets for $305 million.[14][15] TTAM completed the purchase on July 14, 2025, and the company continues to operate as a nonprofit under TTAM's ownership.[16]
As of February 2024, 23andMe had genotyped more than 14 million individuals,[17] and its research database has contributed to hundreds of peer-reviewed publications across areas including Parkinson's disease, depression, COVID-19, autoimmune diseases, and pharmacogenomics.
History
Founding and early growth (2006–2017)
Linda Avey, Paul Cusenza, and Anne Wojcicki founded 23andMe in 2006 to offer genetic testing and interpretation to individuals.[18] Investment documents from 2007 suggest that 23andMe also intended to develop a database for research purposes.[19] In 2007, Google invested $3.9 million in the company, along with Genentech, New Enterprise Associates, and Mohr Davidow Ventures.[20] Wojcicki and Google co-founder Sergey Brin were married at the time.[7]
Technology
23andMe began offering direct-to-consumer genetic testing in November 2007.[18][53] Customers submit a saliva sample from which DNA is extracted and amplified. The amplified DNA is applied to a glass microarray chip manufactured by Illumina, which contains microscopic beads, each bearing a gene probe complementary to a specific genetic variant. Where the customer's DNA matches a probe, the sequences hybridise and a fluorescent label indicates the variant is present. The platform tests hundreds of thousands of variants out of the approximately 10 to 30 million present in the human genome, and the results are compiled into reports informing the customer about variants associated with conditions such as Parkinson's disease, celiac disease, and Alzheimer's disease.[54] In 2008, when the company was offering estimates of predisposition for more than 90 traits and conditions, Time magazine named the product "Invention of the Year".
Customers can download their uninterpreted raw genetic data[55]
Product history and pricing
Product tiers
In late 2009, 23andMe briefly split its service into three products—an Ancestry Edition, a Health Edition, and a Complete Edition—but recombined them a year later.[62][63] A monthly subscription for research-based updates, introduced in late 2010, proved unpopular and was eliminated in mid-2012.[63][64][65]
From November 22, 2013, to October 21, 2015, 23andMe sold only raw genetic data and ancestry-related results in the US due to FDA restrictions,[4]
FDA regulation
The emergence of direct-to-consumer genetic testing raised questions about whether results could be meaningfully interpreted and whether they might lead to genetic discrimination.[55] The regulatory environment for genetic testing companies remained uncertain, with anticipated risk-based frameworks slow to materialise.[63][79]
Research
Overview
Over 80% of 23andMe customers have opted in to having their data used for research.[106][107] The company's research programme has produced hundreds of peer-reviewed publications using its large genotyped and phenotyped participant database. Aggregated customer data is studied by researchers employed by 23andMe and through collaborations with academic, government, and pharmaceutical partners;[5][55][108][109][110]
Informed consent and privacy concerns
Questions have been raised since at least 2013 about whether the company can adequately obtain informed consent through web-based interactions with people submitting samples for genotyping.[129][130]
Data collection and third-party sharing
The company collects not only genetic and personal information from customers but also web behaviour data through its website, apps, cookies, and software.[112][131] A combination of policies within its terms of service—covering cookies, aggregate data disclosure, and targeted advertising—has been described as making 23andMe a valuable data mine for third parties including health insurance companies, pharmaceutical companies
See also
- Genographic Project
- Biobank
- Personal genomics
- Direct-to-consumer genetic testing
- Genetic Information Nondiscrimination Act
Further reading
- 23andMe's New Formula: Patient Consent. Antonio Regalado, MIT Technology Review
External links
References
- Fact Sheet 23andMe, retrieved November 27, 2013^
- Autosomal SNP comparison chart - ISOGG Wiki isogg.org, retrieved 2022-09-04^
- Tim Janzen. Autosomal DNA testing comparison chart Gene by Gene^