23andMe Holding Co., based in South San Francisco, California, is a personal genomics and biotechnology company known for its direct-to-consumer genetic testing service. Customers submit saliva samples for single nucleotide polymorphism genotyping, which generates reports on their ancestry and health predispositions. The name '23andMe' reflects the 23 chromosome pairs in human cells.
Founded in 2006 by Linda Avey, Paul Cusenza, and Anne Wojcicki, 23andMe aimed to offer genetic testing and interpretation to individuals.
In 2006, 23andMe was founded and soon became the first company to offer autosomal DNA testing for ancestry, a method now used by all major companies.
In November 2007, 23andMe began offering direct-to-consumer genetic testing, allowing customers to provide a saliva sample for SNP genotyping.
In 2007, Google invested $3.9 million in 23andMe, along with other investors.
In 2007, Paul Cusenza left 23andMe to join Nodal Exchange as CEO.
In 2007, the full direct-to-consumer testing service in the US was priced at $999.
By August 2008, 23andMe had received licenses that allowed them to continue to do business in California after New York and California provided notice to 23andMe that they needed to obtain a CLIA license.
In 2008, Time named 23andMe's product "Invention of the Year" as it offered estimates for predisposition to over 90 traits and conditions.
23andMe has been in dialogue with the FDA since 2008.
In 2008, 23andMe's saliva-based genetic testing business was named "Invention of the Year" by Time.
In 2008, the price of 23andMe's full direct-to-consumer testing service in the US was reduced to $399.
In late 2009, 23andMe split its genotyping service into three products with different prices but reversed this decision a year later.
In 2009, Linda Avey left 23andMe and later co-founded Curious, Inc. in 2011.
In 2010, 23andMe leveraged its extensive database to independently verify research conducted by the National Institutes of Health (NIH). The study confirmed that mutations in the gene responsible for producing glucocerebrosidase were linked to an increased risk of developing Parkinson's disease.
In 2010, the FDA notified several genetic testing companies, including 23andMe, that their genetic tests are considered medical devices and federal approval is required to market them.
In early 2010, Illumina obtained FDA approval for its BeadXpress system to be used in clinical tests. Before 2010, Illumina only sold instruments labeled "for research use only".
In late 2010, 23andMe introduced a monthly subscription fee for updates based on new medical research findings, but it was unpopular and eliminated in mid-2012.
In 2011, Linda Avey co-founded Curious, Inc. after leaving 23andMe.
In July 2012, 23andMe acquired CureTogether, a crowdsourced platform for treatment ratings with data on over 600 medical conditions. This acquisition enhanced 23andMe's research capabilities and data pool. 23andMe allows customers to consent to the use of their genetic information for medical research, potentially leading to publication in scientific journals.
23andMe first submitted applications for FDA clearance in July and September 2012.
In mid-2012, 23andMe eliminated the unpopular monthly subscription fee introduced in 2010.
In 2012, the price of 23andMe's full direct-to-consumer testing service in the US was reduced to $99 as a loss leader strategy.
In 2012, 23andMe raised $50 million in a Series D venture round, nearly doubling its capital.
In November 2013, the FDA published guidance on how it classified genetic analysis and testing services offered by companies using instruments and chips labeled for "research use only" and those approved for clinical use.
On November 22, 2013, health-related results for US customers who purchased 23andMe tests were suspended while undergoing an FDA regulatory review.
23andMe publicly responded to media reports on November 25, 2013, stating that they recognized that they had not met the FDA's expectations regarding timeline and communication regarding their submission and that their relationship with the FDA is extremely important to them.
After not hearing from 23andMe for six months, the FDA ordered the company to stop marketing its saliva collection kit and personal genome service (PGS) on December 2, 2013, as 23andMe had not demonstrated that they have "analytically or clinically validated the PGS for its intended uses". As of this date, 23andMe stopped all advertisements for its PGS test but was still selling the product.
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.
As of December 5, 2013, 23andMe was selling only raw genetic data and ancestry-related results.
Beginning in 2013, concerns were raised about 23andMe's method of obtaining informed consent from individuals who provided DNA samples for sequencing through their online platform.
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.
In October 2014, 23andMe launched its product, including health-related results, in Canada for CA$99.
Since October 2014, 23andMe has been selling a product with both ancestry and health-related components in Canada.
23andMe had been selling a product with both ancestry and health-related components in the UK since December 2014.
In December 2014, 23andMe began selling a product with both ancestry and health-related components in the UK.
In December 2014, 23andMe launched its product, including health-related results, in the UK for £125.
In 2014, 23andMe submitted a 510(k) application to the FDA to market a carrier test for Bloom syndrome.
The FDA cleared 23andMe's Bloom syndrome carrier test in February 2015.
The FDA sent further clarification about regulation of the test to 23andMe on October 1, 2015.
In October 2015, the price of 23andMe's full testing service in the US was raised to $199.
In October 2015, 23andMe received FDA approval to include a revised health component in its DNA tests ordered in the US.
On October 21, 2015, 23andMe announced it would resume providing health information in the form of carrier status and wellness reports with FDA approval.
In 2015, 23andMe, under the leadership of former Genentech executive Richard Scheller, made a strategic move into the field of drug discovery. The company prioritized research on Parkinson's disease, aiming to identify rare genetic variants associated with the condition using its vast database. Their ultimate goal was to develop effective treatments for Parkinson's disease. Additionally, 23andMe established research partnerships with pharmaceutical companies like Pfizer to investigate the genetic underpinnings of inflammatory bowel diseases such as ulcerative colitis and Crohn's disease.
Since 2015, 23andMe has received requests for user data from law enforcement agencies. However, the company's privacy policy explicitly states that they will not voluntarily share personal information with law enforcement unless legally compelled to do so through a valid court order, subpoena, or search warrant.
In 2015, 23andMe raised $115 million in a Series E offering, increasing its capital to $241 million.
In 2015, 23andMe resumed providing health information to US customers after completing an FDA regulatory review.
In September 2016, 23andMe offered an ancestry-only version at a lower price of $99 with an option to upgrade to include the health component for an additional $125.
The African Genetics Program was launched in October 2016 with a grant from the US National Institutes of Health to rectify the lack of data about Africa by recruiting sub-Saharan Africans to increase the genomic data on racial and ethnic minorities.
In 2016, 23andMe made the decision to discontinue its project aimed at offering customers next-generation sequencing services. According to Anne Wojcicki, the company's CEO, this decision was driven by concerns that the results generated from this advanced technology would be too complex or ambiguous to align with 23andMe's mission of delivering readily understandable and directly useful genetic information to consumers. However, the same year, 23andMe achieved a significant breakthrough by utilizing self-reported data from its customer base to pinpoint 17 genetic loci that appeared to be associated with an increased susceptibility to depression.
In April 2017, the FDA approved 23andMe's applications for ten genetic risk tests, including tests for late-onset Alzheimer's disease, Parkinson's disease, celiac disease, and others.
In June 2017, 23andMe launched a brand marketing advertisement featuring Gru from Despicable Me.
In September 2017, it was rumored that 23andMe was raising $200 million with a $1.5 billion valuation. The company later reported raising $250 million at a $1.75 billion valuation.
In 2017, 23andMe formed research alliances with the pharmaceutical company Lundbeck and the Milken Institute think tank to delve into the genetic basis of psychiatric disorders, particularly bipolar disorder and major depression. These collaborations aimed to unravel the genetic underpinnings of these conditions and accelerate the development of novel therapies.
As of February 2018, 23andMe had genotyped over 3,000,000 individuals, although FDA restrictions had reduced customer growth rates.
In February 2018, 23andMe announced more specific ancestry reporting, telling people what country they were from, not just what region, and increased the number of regions by 120. Also in February 2018, 23andMe announced the Global Genetics Program, which aims to increase the genomic data of 61 underrepresented countries in their database.
In March 2018, the FDA approved another de novo application from 23andMe, this one for a direct-to-consumer test for three specific BRCA mutations that are the most common in people of Ashkenazi descent.
In April 2018, 23andMe announced the Populations Collaboration Program to set up formal collaborations between the company and researchers that are investigating underrepresented countries.
As of May 25, 2018, 23andMe became subject to the General Data Protection Regulation (GDPR). The GDPR is a comprehensive set of regulations aimed at empowering individuals with greater control over their personal data collected, used, and stored digitally or physically. It also imposes restrictions on how companies, including those offering products or services outside the EU, can utilize personal data.
On July 25, 2018, 23andMe announced a partnership with GlaxoSmithKline to use test results from 5 million customers to design new drugs. GlaxoSmithKline invested $300 million in 23andMe.
In 2018, 23andMe released advertisements narrated by Warren Buffett.
In January 2020, 23andMe announced it would lay off about 100 employees.
In June 2020, 23andMe initiated a study involving over 750,000 participants to investigate the relationship between blood type and the likelihood of contracting COVID-19.
In July 2020, 23andMe and GlaxoSmithKline announced their partnership's first clinical trial for a joint asset being co-developed for cancer treatment.
On October 1, 2020, 23andMe started offering "23andMe+", priced at $29/year, for customers of the "Health + Ancestry" service, who completed genotyping on version 5 of the microarray chip. The new service makes available additional reports on health and pharmacogenetics.
In December 2020, 23andMe raised around $82.5 million in a Series F round, bringing the total capital raised over the years to over $850 million.
In February 2021, 23andMe announced a definitive agreement to merge with Sir Richard Branson's VG Acquisition Corp in a $3.5 billion transaction.
In April 2021, 23andMe published the results of their study, which suggested that individuals with type O blood might have a reduced risk of contracting COVID-19. The findings indicated that those with type O blood were 9-18% less likely to become infected and 13-26% less likely to test positive if exposed.
In June 2021, 23andMe completed the merger with VG Acquisition Corp and the combined company was renamed to 23andMe Holding Co.
On June 17, 2021, 23andMe began trading on the Nasdaq stock exchange under the ticker symbol “ME” after completing a merger with VG Acquisition Corp.
In October 2021, 23andMe announced it would acquire Lemonaid Health, a telehealth company, for $400 million.
In 2021, 23andMe became a publicly traded company with a market capitalization of US$6 billion.
In 2021, 23andMe became a publicly traded company with a market capitalization of US$6 billion.
At the end of 2021, 23andMe acquired leading digital healthcare company Lemonaid Health for $400 million to give patients and healthcare providers better information about health risks and treatment.
In January 2022, the partnership between 23andMe and GlaxoSmithKline was extended until July 2023 with an additional $50 million investment.
By July 2023, the partnership between 23andMe and GlaxoSmithKline had been extended with an additional $50 million investment.
In October 2023, 23andMe experienced a significant data breach that compromised the sensitive information of approximately 7 million users, representing roughly half of its customer base at the time. Hackers illicitly obtained personal data, including names, addresses, and genetic information, which was subsequently put up for sale online.
In November 2023, 23andMe published its annual transparency report, revealing that the company had received requests for user data from law enforcement agencies concerning 15 individuals since 2015. The report emphasized 23andMe's commitment to user privacy, stating that the company would not disclose personal information to law enforcement without a legally binding court order, subpoena, or search warrant.
By February 2024, 23andMe announced it had genotyped more than 14,000,000 individuals.
On September 17, 2024, all seven independent directors of 23andMe resigned.
By 2024, 23andMe's valuation had fallen to 2% of its peak, due to factors like lack of recurring revenue from its retail customers.