View source for Company:23andMe

{{Short description|American personal genomics company}}
{{Infobox company
| name = 23andMe Holding Co.
| logo = 23andMe logo.svg
| logo_alt = 23andMe Logo
| image = 23andmeheadquarters.jpg
| image_caption = Former headquarters in Sunnyvale, California
| type = [[Finance:Public company|Public]]
| traded_as = {{NASDAQ|ME}}
| website = {{url|23andme.com}}
| foundation = {{start date and age|2006|04}}
| founders = {{Unbulleted list|Linda Avey|Paul Cusenza| Anne Wojcicki}}
| location_city = South San Francisco, California
| location_country = United States
| key_people = Anne Wojcicki (CEO)<br>Esther Dyson (board member)
| industry = {{Unbulleted list|[[Engineering:Biotechnology|Biotechnology]] | [[Biology:Genetic genealogy|Genetic genealogy]]}}
| products = [[Medicine:Direct-to-consumer advertising|Direct-to-consumer]] [[Biology:Human genome#Personal genomes|personal genome]] testing <br> Mobile application
| services = [[Medicine:Genetic testing|Genetic testing]], genealogical DNA testing, medical research
| owner = 
| num_employees = 816 (2023)
| revenue = {{Increase}} {{US$|299 million|link=yes}} (2023)
| operating_income = {{Decrease}} {{US$|-324 million}} (2023)
| net_income = {{Decrease}} {{US$|-312 million}} (2023)
| assets = {{Decrease}} {{US$|943 million}} (2023)
| equity = {{Decrease}} {{US$|714 million}} (2023)
| footnotes = Financials {{asof|2023|03|31|lc=y|df=US}}<ref name=AR>{{cite web |url=https://www.sec.gov/ix?doc=/Archives/edgar/data/1804591/000095017023024232/me-20230331.htm |title=23andMe Holding Co. Fiscal 2022 Annual Report (Form 10-K) |date=May 25, 2023 |publisher=U.S. Securities and Exchange Commission}}</ref>
}}
'''23andMe Holding Co.''' is a publicly held [[Biology:Personal genomics|personal genomics]] and [[Engineering:Biotechnology|biotechnology]] company based in South San Francisco, California.<ref name=AR /><ref>{{cite web |url=https://www.bizjournals.com/sanjose/news/2022/06/08/23andme-moves-downsizes-hq.html |title=23andMe has officially moved and downsized its HQ |date=June 8, 2022 |work={{wipe|American City Business Journals}} |last=Nguyen-Fleige |first=Chelsea |archive-url=http://archive.today/2022.06.09-153912/https://www.bizjournals.com/sanjose/news/2022/06/08/23andme-moves-downsizes-hq.html |archive-date=June 9, 2022 |url-status=live}}</ref> It is best known for providing a direct-to-consumer genetic testing service in which customers provide a [[Medicine:Saliva testing|saliva sample]] that is laboratory analysed, using [[Biology:SNP genotyping|single nucleotide polymorphism genotyping]],<ref name=Wired2007/> 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 [[Biology:Chromosome|chromosome]]s in a diploid human [[Biology:Cell|cell]].<ref name="Facts">{{cite web|title=Fact Sheet|url=http://mediacenter.23andme.com/fact-sheet/|archive-url=https://web.archive.org/web/20130119085732/http://mediacenter.23andme.com/fact-sheet/|url-status=dead|archive-date=January 19, 2013|publisher=23andMe|access-date=November 27, 2013}}</ref>

The company had a previously fraught relationship with the United States [[Organization:Food and Drug Administration|Food and Drug Administration]] (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.<ref name="Herper">{{cite news|last=Herper|first=Matthew|title=23andMe Stops Offering Genetic Tests Related to Health|url=https://www.forbes.com/sites/matthewherper/2013/12/05/23andme-stops-offering-genetic-tests-related-to-health/|access-date=December 6, 2013|newspaper=Forbes|date=December 5, 2013|archive-url=https://web.archive.org/web/20140209053629/http://www.forbes.com/sites/matthewherper/2013/12/05/23andme-stops-offering-genetic-tests-related-to-health/|archive-date=February 9, 2014|url-status=live}}</ref><ref name="Pollack">{{Cite news|title=23andMe Will Resume Giving Users Health Data |url=https://www.nytimes.com/2015/10/21/business/23andme-will-resume-giving-users-health-data.html |newspaper=The New York Times |date=October 21, 2015 |access-date=October 21, 2015 |issn=0362-4331 |first=Andrew |last=Pollack |archive-url=https://web.archive.org/web/20160304162116/http://www.nytimes.com/2015/10/21/business/23andme-will-resume-giving-users-health-data.html?_r=1 |archive-date=March 4, 2016 |url-status=live }}</ref> 23andMe has been selling a product with both ancestry and health-related components in Canada since October 2014,<ref name="Ubelacker">{{cite news|last1=Ubelacker|first1=Sheryl|title=U.S. company launches genetic health and ancestry info service in Canada|url=http://www.winnipegfreepress.com/arts-and-life/life/health/us-company-launches-genetic-health-and-ancestry-info-service-in-canada-277718411.html|access-date=October 7, 2014|work=Winnipeg Free Press|agency=The Canadian Press|date=October 1, 2014}}</ref><ref name="Hansen">{{cite news|last1=Hansen|first1=Darah|title=5Q: Anne Wojcicki, CEO 23andMe on knowing your DNA data (and being married to the boss of Google)|url=https://ca.finance.yahoo.com/news/5q--anne-wojcicki--ceo-23andme-on-knowing-your-dna-data--and-being-married-to-the-boss-of-google-203324408.html|access-date=October 7, 2014|work=Yahoo Finance Canada|date=October 2, 2014}}</ref><ref name="CBCNews">{{cite news|title=23andme genetic testing service raises ethical questions|url=http://www.cbc.ca/news/business/23andme-genetic-testing-service-raises-ethical-questions-1.2785522|access-date=October 7, 2014|work=CBC News|date=October 2, 2014}}</ref> and in the UK since December 2014.<ref name="Roberts">{{cite news|last1=Roberts|first1=Michelle|last2=Rincon|first2=Paul|title=Controversial DNA test comes to UK|url=https://www.bbc.com/news/science-environment-30285581|access-date=December 2, 2014|work=BBC News|date=December 2, 2014}}</ref>

In 2007, 23andMe became the first company to begin offering autosomal DNA testing for ancestry, which all other major companies now use.<ref>{{Cite web |title=Autosomal SNP comparison chart - ISOGG Wiki |url=https://isogg.org/wiki/Autosomal_SNP_comparison_chart |access-date=2022-09-04 |website=isogg.org |language=en}}</ref> Its saliva-based direct-to-consumer genetic testing business was named "Invention of the Year" by ''{{wipe|Time (magazine)}}'' in 2008.<ref name = Time/><ref>{{cite web |url=https://mediacenter.23andme.com/company/about-us/ |title=About Us |website=23andMe |access-date=February 11, 2018 |archive-date=February 14, 2018 |archive-url=https://web.archive.org/web/20180214073640/https://mediacenter.23andme.com/company/about-us/ |url-status=dead }}</ref><ref>{{cite book |chapter-url=https://isogg.org/wiki/Autosomal_DNA_testing_comparison_chart |title=Autosomal DNA testing comparison chart |last1=Janzen |first1=Tim |display-authors=et al. |chapter=Family Tree DNA Learning Center |publisher=Gene by Gene }}</ref>

23andMe became a publicly traded company in 2021 and soon had a market capitalization of US$6 billion.<ref name="Winkler 2024">{{cite web |last1=Winkler |first1=Rolfe |title=23andMe’s Fall From $6 Billion to Nearly $0 |url=https://www.wsj.com/health/healthcare/23andme-anne-wojcicki-healthcare-stock-913468f4 |website=Wall Street Journal |date=31 January 2024}}</ref> By 2024, its valuation had fallen to 2% of that peak.<ref name="Winkler 2024"/>

==History==
Linda Avey, Paul Cusenza and Anne Wojcicki founded 23andMe in 2006 to offer [[Medicine:Genetic testing|genetic testing]] and interpretation to individuals.<ref name="Wired2007">{{cite magazine|url=https://www.wired.com/medtech/genetics/magazine/15-12/ff_genomics?currentPage=all|title=23AndMe Will Decode Your DNA for $1,000. Welcome to the Age of Genomics|last=Goetz|first=Thomas|access-date=April 5, 2012|date=November 17, 2007|magazine=Wired|archive-url=https://web.archive.org/web/20140312001152/http://www.wired.com/medtech/genetics/magazine/15-12/ff_genomics?currentPage=all|archive-date=March 12, 2014|url-status=live}}</ref> Investment documents from 2007 also suggest that 23andMe hoped to develop a database to pursue research efforts.<ref>{{cite news|title=All those 23andMe spit tests were part of a bigger plan firm|url=https://www.bloomberg.com/news/features/2021-11-04/23andme-to-use-dna-tests-to-make-cancer-drugs}}</ref> In 2007, [[Company:Google|Google]] invested $3.9 million in the company, along with [[Company:Genentech|Genentech]], New Enterprise Associates, and Mohr Davidow Ventures.<ref>{{cite news|title=Google invests in genetics firm|url=http://news.bbc.co.uk/2/hi/business/6682451.stm|work=BBC News|date=May 22, 2007|access-date=June 28, 2007}}</ref> Wojcicki and Google co-founder [[Biography:Sergey Brin|Sergey Brin]] were married at the time.<ref name=Hansen/>

In 2007, Cusenza left to join Nodal Exchange as CEO the following year.<ref>{{cite web|url=http://www.nodalexchange.com/about_nodal/corporate_governance/board.php|title=Board Of Directors|publisher=Nodal Exchange|access-date=November 27, 2013|archive-url=https://web.archive.org/web/20131203001050/http://www.nodalexchange.com/about_nodal/corporate_governance/board.php|archive-date=December 3, 2013|url-status=dead|df=mdy-all}}</ref> Avey left in 2009 and co-founded Curious, Inc. in 2011.<ref>{{Cite web |url=http://www.wearecurio.us/ |title=Curious: We've got questions<!-- Bot generated title --> |access-date=April 7, 2014 |archive-url=https://web.archive.org/web/20140225074754/http://wearecurio.us/ |archive-date=February 25, 2014 |url-status=dead }}</ref>

In 2012, 23andMe raised $50 million in a Series D [[Finance:Venture round|venture round]], almost doubling its capital of $52.6 million.<ref name="Tsotsis" /> In 2015, 23andMe raised $115 million in a Series E offering, increasing capital to $241 million.<ref name="Pollack" /><ref>{{cite news|last1=Chen|first1=Caroline|title=23andMe Funding Values Genetics Startup at $1.1 Billion|url=https://www.bloomberg.com/news/articles/2015-10-14/23andme-funding-said-to-value-genetics-startup-at-1-1-billion|access-date=October 25, 2015|work=Bloomberg Business|date=October 14, 2015}}</ref><ref>{{cite web|title=Notice of Exempt Offering of Securities|url=https://www.sec.gov/Archives/edgar/data/1414053/000141405315000002/xslFormDX01/primary_doc.xml|publisher=U.S. Securities and Exchange Commission|access-date=July 11, 2015}}</ref>

In June 2017, 23andMe created a brand marketing advertisement featuring Gru from ''Despicable Me''.<ref>Luttner, Kathryn. [https://www.campaignlive.com/article/23andme-partners-despicable-3-first-movie-partnership/1435366 "23andMe partners with 'Despicable Me 3' for first movie partnership"] ''Campaign'', June 2, 2017. Retrieved April 22, 2018</ref> In 2018, the company launched advertisements narrated by Warren Buffett.<ref>{{cite web|url=https://www.omaha.com/money/buffett/warren-buffett-narrates-andme-commercial/article_09d847de-9cb0-5381-8ecd-5f1ce01d6302.html|title=Warren Buffett narrates 23andMe commercial|first=Steve|last=Jordon|website=Omaha.com|date=January 28, 2018 }}</ref>

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.<ref>{{cite news |last1=Lynley |first1=Matthew |last2=Roof |first2=Katie |title=23andMe hits $1.5B pre-money valuation in latest huge funding round |url=https://techcrunch.com/2017/09/06/23andme-hits-1-5b-pre-money-valuation-in-latest-huge-funding-round/ |work=Techcrunch |date=September 6, 2017}}</ref> Afterwards, it was reported the company raised $250 million, at a $1.75 billion valuation.<ref>{{cite news |last1=Prashad |first1=Spencer |last2=Srikanthan |first2=Shan |title=23andMe: Building a Genetically-Sound Company |url=http://iveybusinessreview.ca/cms/6346/23andme-building-genetically-sound-company/ |work=Ivey Business Review |date=April 9, 2018}}</ref>

On July 25, 2018, 23andMe announced it a partnership with [[Company:GlaxoSmithKline|GlaxoSmithKline]] to allow the pharmaceutical company to use test results from 5 million customers to design new drugs. GlaxoSmithKline invested $300 million in the company.<ref>{{cite news |last=Fox |first=Maggie |url=https://www.nbcnews.com/health/health-news/drug-giant-glaxo-teams-dna-testing-company-23andme-n894531 |title=Drug giant Glaxo teams up with DNA testing company 23andMe |work=NBC News |date=July 25, 2018 |access-date=July 26, 2018 }}</ref> In January 2022, this partnership was extended until July 2023 with an additional $50 million payment from GlaxoSmithKline.<ref>{{Cite web |title=23andMe is getting $50M from GSK to extend their research partnership |url=https://www.bizjournals.com/sanjose/news/2022/01/18/23andme-gets-50m-from-gsk-to-extend-research-deal.html |access-date=2022-05-08 |website=www.bizjournals.com}}</ref>

In January 2020, 23andMe announced it would lay off about 100 of its employees.<ref>{{Cite web|url=https://www.cnbc.com/2020/01/23/23andme-lays-off-100-people-ceo-anne-wojcicki-explains-why.html|title=23andMe lays off 100 people as DNA test sales decline, CEO says she was 'surprised' to see market turn|last=Farr|first=Christina|date=2020-01-23|website=CNBC|language=en|access-date=2020-01-26}}</ref>

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.<ref name="PRJuly29">{{cite press release|title=23andMe and GSK Begin First Clinical Trial with Cancer Therapy|url=https://blog.23andme.com/news/23andme-and-gsk-clinical-trial/|publisher=23andMe|date=2020-07-29|access-date=2020-08-03}}</ref>

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.<ref>{{cite news |last1=Etherington |first1=Darrell |title=23andMe raises $82.5 million in new funding |url=https://techcrunch.com/2020/12/29/23andme-raises-82-5-million-in-new-funding/ |work=Techcrunch |date=December 29, 2020}}</ref>

In February 2021, the company announced that it had entered into a definitive agreement to merge with Sir [[Biography:Richard Branson|Richard Branson]]'s [[Finance:Special-purpose acquisition company|special-purpose acquisition company]], VG Acquisition Corp, in a $3.5 billion transaction.<ref>{{Cite web|url=https://www.bloomberg.com/news/articles/2021-02-04/23andme-to-go-public-as-3-5-billion-company-via-branson-merger|title=23andMe Goes Public as $3.5 Billion Company With Branson Aid|date=2021-02-04|website=[[Company:Bloomberg L.P.|Bloomberg]]|language=en-US|access-date=2021-02-04}}</ref>

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 [[Finance:Nasdaq|Nasdaq]] stock exchange on June 17, 2021 under the ticker symbol “ME”.<ref>{{Cite web|url=https://23andme.gcs-web.com/news-releases/news-release-details/23andme-successfully-closes-its-business-combination-vg|title=23andMe Successfully Closes its Business Combination with VG Acquisition Corp.|date=2021-06-17|website=23andMe}}</ref>

In October 2021, 23andMe announced that it would acquire Lemonaid Health, a [[Social:Telehealth|telehealth]] company, for $400 million with the deal closing in November.<ref>{{Cite news|url=https://www.healthleadersmedia.com/telehealth/23andme-will-spend-400m-acquire-lemonaid-health|author=John Commins|title=23andME Will Spend $400M To Acquire Lemonaid Health|date=October 26, 2021|work=Health Leaders Media}}</ref><ref>{{cite press release |url=https://apnews.com/press-release/globe-newswire/technology-science-health-2740786c803b0c219daa538a951f64d8 |title=23andMe Reports FY2022 Fourth Quarter and Full Year Financial Results |via=AP News |date=26 May 2022}}</ref>

==Government regulation in the United States==
The new genetic testing service and ability to map significant portions of the [[Biology:Genome|genome]] has raised controversial questions, including whether the results can be interpreted meaningfully and whether they will lead to [[Social:Genetic discrimination|genetic discrimination]].<ref name = Time/><ref name=Jeffries/> The regulatory environment for genetic testing companies has been uncertain, and anticipated risk-based regulation catering for different types of genetic tests has not yet materialized.<ref name=Vorhaus2010/><ref>{{cite web|last=Greely|first=Hank|title=The FDA drops an anvil on 23andMe – now what?|url=http://blogs.law.stanford.edu/lawandbiosciences/2013/11/25/the-fda-drops-an-anvil-on-23andme-%E2%80%93-now-what/|publisher=Stanford University|date=November 25, 2013|access-date=November 29, 2013|quote=FDA had promised a risk-based regulatory scheme, but we don’t know what it is.|archive-url=https://web.archive.org/web/20131129144904/http://blogs.law.stanford.edu/lawandbiosciences/2013/11/25/the-fda-drops-an-anvil-on-23andme-%E2%80%93-now-what/|archive-date=November 29, 2013|url-status=dead|df=mdy-all}}</ref><ref name=23andMeUpdate/>

=== State regulators ===
In 2008, the states of New York and {{wipe|California}} each provided notice to 23andMe and similar companies, that they needed to obtain a CLIA license in order to sell tests in those states.<ref name="Time">{{Cite magazine|last=Hamilton|first=Anita|url=http://www.time.com/time/specials/packages/article/0,28804,1852747_1854493,00.html |archive-url=https://web.archive.org/web/20081102044918/http://www.time.com/time/specials/packages/article/0,28804,1852747_1854493,00.html |url-status=dead |archive-date=November 2, 2008 | title = Best Inventions of 2008 | magazine = {{wipe|Time (magazine)}} | date=October 29, 2008 | access-date = April 5, 2012}}</ref><ref>{{Cite news|url=https://www.forbes.com/2008/04/17/genes-regulation-testing-biz-cx_mh_bl_0418genes.html |title=States Crack Down On Online Gene Tests |first1=Robert |last1=Langreth |first2=Matthew |last2=Herper |work=Forbes |date=April 18, 2008 }}</ref><ref>{{Cite news|url=https://www.washingtonpost.com/wp-dyn/content/article/2008/06/17/AR2008061702720.html |title=Cease And Desist: California Tries to Unravel 23andMe's Genetic Testing |first=Jason |last=Kincaid |work=TechCrunch.com |via=The Washington Post |date=June 18, 2008 }}</ref> By August 2008, 23andMe had received licenses that allow them to continue to do business in California.<ref>{{cite news | url = https://www.nytimes.com/2008/08/20/business/20gene.html?_r=4&ref=health&oref=slogin&oref=slogin&oref=slogin&oref=slogin | work=The New York Times | first=Andrew | last=Pollack | title=California Licenses 2 Companies to Offer Gene Services | date=August 20, 2008}}</ref>

=== FDA ===
According to Anne Wojcicki, 23andMe has been in dialogue with the FDA since 2008.<ref name="23andMeUpdate">{{cite web|last=Wojcicki|first=Anne|title=An Update Regarding The FDA's Letter to 23andMe|url=http://blog.23andme.com/news/an-update-regarding-the-fdas-letter-to-23andme/|date=November 26, 2013|publisher=23andMe|access-date=November 27, 2013}}</ref> In 2010, the FDA notified several genetic testing companies, including 23andMe, that their genetic tests are considered [[Medicine:Medical device|medical device]]s and federal approval is required to market them; a similar letter was sent to [[Company:Illumina|Illumina]], which makes the instruments and chips used by 23andMe in providing its service.<ref name=Vorhaus2010/><ref>{{cite news|title=FDA cracking down on genetic tests|url=http://www.nbcnews.com/id/37638671/#.UpWQiNIwrIy|access-date=November 27, 2013|newspaper=NBC|date=June 11, 2010}}</ref><ref>{{cite news|last1=Pollack|first1=Andrew|title=F.D.A. Faults 5 Companies on Genetic Tests|url=https://www.nytimes.com/2010/06/12/health/12genome.html|work=The New York Times|date=June 11, 2010}}</ref> 23andMe first submitted applications for FDA clearance in July and September 2012.<ref name="FDAWarning">{{cite web|url=https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm376296.htm|title = Inspections, Compliance, Enforcement, and Criminal Investigations – 23andMe, Inc.|publisher=FDA|date=November 22, 2013|access-date=November 25, 2013}}</ref>

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.<ref>{{cite news|last1=Malone|first1=Bill|title=A New Chapter in FDA Regulation|url=https://www.aacc.org/publications/cln/articles/2014/february/fda-regulation|work=AACC.org – Clinical Laboratory News|date=February 1, 2014}}</ref>

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".<ref name=FDAWarning/><ref>{{cite web|url=https://abcnews.go.com/Business/wireStory/fda-tells-23andme-halt-sales-genetic-test-21004582|title = FDA Tells 23andMe to Halt Sales of Genetic Test|last = Perrone|first = Matthew|date = November 25, 2013|access-date = November 25, 2013|work = ABC News}}</ref><ref>{{cite magazine|url=http://www.fastcompany.com/3022208/fda-tells-23andme-founder-anne-wojcicki-to-stop-marketing-99-genetic-test-or-face-penalties|title = FDA To 23andMe Founder Anne Wojcicki: Stop Marketing $99 DNA Test Or Face Penalties |last= Gray|first = Tyler|date = November 25, 2013|access-date = November 25, 2013|magazine = Fast Company}}</ref> {{As of|2013|12|2|df=US}}, 23andMe had stopped all advertisements for its PGS test but is still selling the product.<ref>{{cite web|url=http://www.fiercemedicaldevices.com/story/23andme-pulls-ads-after-fda-warning-sales-roll/2013-12-03|title=23andMe pulls ads after FDA warning, but sales roll on|last=Garde|first=Damian|work=FierceMedicalDevices|publisher=FierceMarkets|date=December 3, 2013|access-date=December 4, 2013}}</ref><ref>{{cite news|last=del Castillo|first=Michael|title=Calm down about 23andMe, the media is getting it wrong|url=http://upstart.bizjournals.com/news/technology/2013/12/03/23andme-website-after-fda-warning.html|access-date=December 5, 2013|newspaper=Upstart Business Journal|date=December 3, 2013}}</ref> {{As of|2013|12|5|df=US}}, 23andMe was selling only raw genetic data and ancestry-related results.<ref name=Herper/><ref name=PRDec5/><ref name=Fung/>

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."<ref name="Khan">{{cite magazine|url=http://www.slate.com/blogs/future_tense/2013/11/25/fda_letter_to_23andme_won_t_mean_anything_in_the_long_run.html|title = The FDA's Battle With 23andMe Won't Mean Anything in the Long Run|last = Khan|first = Razib|date = November 25, 2013|magazine = Slate Magazine|access-date = November 25, 2013}}</ref><ref>{{cite news|url=https://techcrunch.com/2013/11/25/23andme-fda-block/|title = DNA Testing Startup 23andMe Hits A Snag As FDA Shuts Down Sales Of Home Testing Kit|last = Etherington|first = Darrell|date = November 25, 2013|access-date = November 25, 2013|work = TechCrunch}}</ref><ref>{{cite magazine|url=http://www.technologyreview.com/view/522001/updated-fda-orders-23andme-to-stop-genetic-tests/|title = Updated: FDA Orders 23andMe to Stop Genetic Tests|last = Young|first = Susan|date = November 25, 2013|access-date = November 25, 2013|magazine = Technology Review}}</ref> 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."<ref name=23andMeUpdate/>

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.<ref name=Herper/><ref name=PRDec5/><ref name=Fung/>

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.<ref>{{cite news|last1=Farr|first1=Christina|title=Gene startup 23andme casts eyes abroad after U.S. regulatory hurdle|url=https://www.reuters.com/article/23andme-genetictesting-idUSL2N0NS0Y820140506|access-date=July 17, 2014|work=Reuters|date=May 6, 2014|archive-url=https://web.archive.org/web/20140527154237/https://www.reuters.com/article/2014/05/06/23andme-genetictesting-idUSL2N0NS0Y820140506|archive-date=May 27, 2014|url-status=live}}</ref> 23andMe had been selling a product with both ancestry and health-related components in Canada since October 2014,<ref name=Ubelacker/><ref name=Hansen/><ref name=CBCNews/> and in the UK since December 2014.<ref name=Roberts/>

In 2014, 23andMe submitted a 510(k) application to the FDA to market a [[Medicine:Carrier testing|carrier test]] for [[Medicine:Bloom syndrome|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]] showing that the specific tests that 23andMe offered were associated with Blooms.<ref name=FDAbloom/><ref>{{cite web|title=Device Classification under Section 513(f)(2)(de novo)|url=https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=den140044|website=accessdata.fda.gov|publisher=FDA|access-date=April 7, 2017}}.  23andMe's [https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=4679 Autosomal Recessive Carrier Screening Gene Mutation Detection System] in FDA database</ref> 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.<ref name="FDAbloom">{{Cite news|url = https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm435003.htm|title = FDA permits marketing of first direct-to-consumer genetic carrier test for Bloom syndrome|date = February 19, 2015|work = FDA News Release}}</ref><ref>{{cite news|title=23andMe Gets FDA Clearance to Market Bloom Syndrome Carrier Test Directly to Consumers|url=https://www.genomeweb.com/molecular-diagnostics/23andme-gets-fda-clearance-market-bloom-syndrome-carrier-test-directly|work=GenomeWeb|date=February 19, 2015|language=en}}</ref> The FDA sent further clarification about regulation of the test to 23andMe on October 1, 2015.<ref>{{cite web|title=Letter re DEN140044|url=https://www.accessdata.fda.gov/cdrh_docs/pdf14/den140044.pdf|publisher=FDA|date=October 1, 2015}}.  [https://www.accessdata.fda.gov/cdrh_docs/reviews/den140044.pdf Decision Summary: Evaluation of DEN140044] revising February 2015 evaluation.</ref>

On October 21, 2015, 23andMe announced that it would begin marketing carrier tests in the US again.<ref name=Pollack/> 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).<ref>{{Cite news|url=https://www.wsj.com/articles/disconnect-between-silicon-valley-and-regulators-over-health-technologies-23andme-ceo-says-1477522539|title=Disconnect Between Silicon Valley and Regulators Over Health Technologies, 23andMe CEO Says|last=Bensinger|first=Greg|date=October 26, 2016|newspaper=Wall Street Journal|issn=0099-9660|access-date=November 23, 2016}}</ref>

23andMe submitted a "[[Medicine:Federal Food, Drug, and Cosmetic Act#Automatic Class III Designation (De Novo classification)|de novo]]" application to the FDA to market tests that provide people with information about whether they have gene mutations or [[Biology:Allele|allele]]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 [[Medicine:Alzheimer's disease|Alzheimer's disease]], [[Medicine:Parkinson's disease|Parkinson's disease]], [[Medicine:Coeliac disease|celiac disease]], hereditary thrombophilia, [[Medicine:Alpha 1-antitrypsin deficiency|alpha-1 antitrypsin deficiency]], [[Medicine:Glucose-6-phosphate dehydrogenase deficiency|glucose-6-phosphate dehydrogenase deficiency]], early-onset of [[Medicine:Dystonia|dystonia]], factor XI deficiency, and [[Medicine:Gaucher's disease|Gaucher's disease]].<ref name="FDA10">{{cite web|title= FDA allows marketing of first direct-to-consumer tests that provide genetic risk information for certain conditions|url=https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm551185.htm|publisher=FDA|language=en|date=April 6, 2017}}</ref><ref>{{cite news|last1=Kolata|first1=Gina|title=F.D.A. Will Allow 23andMe to Sell Genetic Tests for Disease Risk to Consumers|url=https://www.nytimes.com/2017/04/06/health/fda-genetic-tests-23andme.html|work=The New York Times|date=April 6, 2017}}</ref> 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.<ref name=FDA10/>

In March 2018, the FDA approved another ''de novo'' application from the company, this one for a DTC test for three specific [[Medicine:BRCA mutation|''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.<ref>{{Cite web|last=Stallings|first=Erika|date=2018-03-30|title=Opinion {{!}} Allowing 23andMe To Test For BRCA May Do More Harm Than Good|url=https://www.huffpost.com/entry/opinion-stallings-23andme-brca_n_5ab90fe4e4b008c9e5f9b8cd|access-date=2021-02-11|website=HuffPost|language=en}}</ref> These mutations increase the risk of [[Medicine:Breast cancer|breast]] and [[Medicine:Ovarian cancer|ovarian cancer]] in women, and the risk of breast and [[Medicine:Prostate cancer|prostate cancer]] in men.<ref>{{cite news|title=FDA authorizes, with special controls, direct-to-consumer test that reports three mutations in the BRCA breast cancer genes|url=https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm599560.htm|work=FDA|date=March 6, 2018|language=en}}</ref>

==Products==

===Direct-to-consumer genetic testing===
[[File:23andMe DNA test - 31 January 2021 - complete kit.jpg|thumb|A 23andMe 2021 genome testing kit]]
[[File:23andme-testkit.jpg|thumb|A 23andMe 2013 genome testing kit]]

23andMe began offering direct-to-consumer genetic testing in November 2007. Customers provide a [[Medicine:Saliva testing|saliva testing]] sample that is partially [[Biology:SNP genotyping|single nucleotide polymorphism (SNP) genotyped]] and results are posted online.<ref name="Wired2007" /><ref>{{cite web |title=Our Service: Genotyping Technology |url=https://www.23andme.com/more/genotyping/ |publisher=23andMe |access-date=November 27, 2013 |archive-url=https://web.archive.org/web/20131202222247/https://www.23andme.com/more/genotyping/ |archive-date=December 2, 2013 |url-status=dead |df=mdy-all}}</ref><ref>{{cite web |last=Hadly |first=Scott |title=23andMe's New Custom Chip |url=http://blog.23andme.com/news/23andmes-new-custom-chip/ |access-date=November 27, 2013 |publisher=23andMe |date=November 18, 2013}}</ref> 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".<ref name="Time" />

After the sample is received by the lab, the DNA is extracted from the saliva and amplified so that there is enough to be [[Biology:Genotype|genotype]]d. The DNA is then cut into small pieces, and applied to a glass [[Microarray analysis techniques|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 [[Biology:Nucleic acid hybridization|hybridize]], or bind together, letting researchers know that this variant is present in the customer's genome by a [[Biology:Fluorescent tag|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.<ref>Madara, Jason. [https://www.wired.co.uk/article/the-extraction-process "The extraction process: meet 23andme's Anne Wojcicki"], ''WIRED UK'', March 6, 2017. Retrieved April 17, 2018.</ref>

Uninterpreted raw genetic data may be downloaded by customers.<ref name="Jeffries">{{cite news |last1=Jeffries |first1=Adrianne |title=Genes, patents, and big business: at 23andMe, are you the customer or the product? |url=https://www.theverge.com/2012/12/12/3759198/23andme-genetics-testing-50-million-data-mining |access-date=July 17, 2014 |work=[[The Verge]] |date=December 12, 2012 |archive-url=https://web.archive.org/web/20140102093742/http://www.theverge.com/2012/12/12/3759198/23andme-genetics-testing-50-million-data-mining |archive-date=January 2, 2014 |url-status=live}}</ref> This provides customers with the ability to choose one of the 23 chromosomes, as well as [[Biology:Mitochondrial DNA|mitochondrial DNA]], and see which base is located in certain positions in [[Biology:Gene|gene]]s, and see how these compare to other common variants. Customers who bought tests with an ancestry-related component have online access to [[Biology:Genealogical DNA test|genealogical DNA test]] results and tools, including a relative-matching database. Customers can also view their [[Biology:Human mitochondrial DNA haplogroup|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 [[Biology:Heredity|inherited]] [[Biology:Phenotypic trait|traits]] and [[Medicine:Genetic disorder|genetic disorder]] risks.<ref name="Herper" /><ref>{{Cite news |url=https://www.usatoday.com/tech/webguide/internetlife/2007-11-20-23andme-launch_N.htm |title=Google-backed 23andMe offers $999 DNA test |access-date=April 5, 2012 |work=[[Software:USA Today|USA Today]] |first=Lisa |last=Baertlein |date=November 20, 2007 |archive-url=https://web.archive.org/web/20140526120927/http://usatoday30.usatoday.com/tech/webguide/internetlife/2007-11-20-23andme-launch_N.htm |archive-date=May 26, 2014 |url-status=live }}</ref><ref>{{cite news |last1=Swarns |first1=Rachel L. |title=With DNA Testing, Suddenly They Are Family |url=https://www.nytimes.com/2012/01/24/us/with-dna-testing-adoptees-find-a-way-to-connect-with-family.html?pagewanted=all&_r=0 |access-date=July 17, 2014 |work=The New York Times |date=January 23, 2012 |archive-url=https://web.archive.org/web/20140717080805/http://www.nytimes.com/2012/01/24/us/with-dna-testing-adoptees-find-a-way-to-connect-with-family.html?pagewanted=all&_r=0 |archive-date=July 17, 2014 |url-status=live}}</ref> 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.<ref name="Pollack" /><ref name="PRDec5">{{cite press release |title=23andMe, Inc. provides update on FDA regulatory review |url=http://mediacenter.23andme.com/press-releases/23andme-inc-provides-update-on-fda-regulatory-review/ |publisher=23andMe |date=December 5, 2013 |access-date=December 6, 2013}}</ref><ref name="Fung">{{cite news |last=Fung |first=Brian |title=Bowing again to the FDA, 23andMe stops issuing health-related genetic reports |url=https://www.washingtonpost.com/blogs/the-switch/wp/2013/12/06/bowing-again-to-the-fda-23andme-stops-issuing-health-related-genetic-reports/ |access-date=December 6, 2013 |newspaper=The Washington Post |date=December 6, 2013}}</ref> Customers who bought tests from 23andMe's Canadian and UK locations have access to some, but not all, health-related results.<ref name="Ubelacker" /><ref name="Roberts" />

As of February 2018, 23andMe has [[Biology:Genotyping|genotyped]] over 3,000,000 individuals.<ref name="MIT">{{Cite news |url=https://www.technologyreview.com/s/610233/2017-was-the-year-consumer-dna-testing-blew-up/ |title=2017 was the year consumer DNA testing blew up |last=Regalado |first=Antonio |date=February 12, 2018 |work=MIT Technology Review |access-date=February 20, 2018 |language=en}}</ref> FDA marketing restrictions reduced customer growth rates.<ref name="Kiss">{{cite news |last=Kiss |first=Jemima |title=23andMe admits FDA order 'significantly slowed up' new customers |url=https://www.theguardian.com/technology/2014/mar/09/google-23andme-anne-wojcicki-genetics-healthcare-dna |access-date=March 10, 2014 |newspaper=The Guardian |date=March 9, 2014 |archive-url=https://web.archive.org/web/20140316171535/http://www.theguardian.com/technology/2014/mar/09/google-23andme-anne-wojcicki-genetics-healthcare-dna |archive-date=March 16, 2014 |url-status=live}}</ref> As of December 2022, 23andMe has genotyped over 5,000,000 individuals.<ref>{{Cite web |last=23andMe |title=DNA Ancestry Test Kit: Find DNA Relatives - 23andMe International |url=https://www.23andme.com/en-int/dna-ancestry/ |access-date=2022-12-27 |website=www.23andme.com |language=en-int}}</ref>

23andMe is commonly used for [[Social:Donor conceived person|donor conceived people]] to find their biological siblings and in some cases their sperm or egg donor.<ref>{{cite web |url=https://www.cbc.ca/news/technology/sperm-donor-dna-testing-1.4500517 |title=No more Mr. Anonymous for sperm donors |first1=Emily |last1=Chung |first2=Melanie |last2=Glanz |first3=Vik |last3=Adhopia |date=January 25, 2018 |website=CBC News}}</ref>

====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.<ref>{{cite web |last=Wu |first=Shirley|title=Get Just the Information You Want: 23andMe To Offer Separate Health and Ancestry Editions |url=http://blog.23andme.com/news/get-just-the-information-you-want-23andme-to-offer-separate-health-and-ancestry-editions/ |publisher=23andMe |date=November 13, 2009 |access-date=November 29, 2013 |archive-url=https://web.archive.org/web/20131202233939/http://blog.23andme.com/news/get-just-the-information-you-want-23andme-to-offer-separate-health-and-ancestry-editions/ |archive-date=December 2, 2013 |url-status=dead |df=mdy-all}}</ref> This decision was reversed a year later, when the different products were recombined.<ref name="Vorhaus2010">{{cite web |last=Vorhaus |first=Dan |title=A Thanksgiving Tradition: 23andMe Repackages Product, Raises Prices |url=http://www.genomicslawreport.com/index.php/2010/11/23/a-thanksgiving-tradition-23andme-repackages-product-raises-prices/ |work=Genomics Law Report |publisher=Robinson Bradshaw & Hinson |date=November 23, 2010 |access-date=November 29, 2013 |archive-url=https://web.archive.org/web/20131203004925/http://www.genomicslawreport.com/index.php/2010/11/23/a-thanksgiving-tradition-23andme-repackages-product-raises-prices/ |archive-date=December 3, 2013 |url-status=live}}</ref> In late 2010, the company introduced a monthly subscription fee for updates based on new medical research findings.<ref name=Vorhaus2010/><ref>{{cite news |last=MacArthur |first=Daniel |title=News from 23andMe: a bigger chip, a new subscription model and another discount drive |url=https://www.wired.com/wiredscience/2010/11/news-from-23andme-a-bigger-chip-a-new-subscription-model-and-another-discount-drive/ |access-date=November 27, 2013 |newspaper=Wired |date=November 24, 2010 |archive-url=https://web.archive.org/web/20130629194059/http://www.wired.com/wiredscience/2010/11/news-from-23andme-a-bigger-chip-a-new-subscription-model-and-another-discount-drive |archive-date=June 29, 2013 |url-status=live}}</ref> The subscription model proved unpopular with customers and was eliminated in mid-2012.<ref>{{cite news |title=23andMe Eliminates Subscription Model |url=http://www.genomeweb.com/mdx/23andme-eliminates-subscription-model |access-date=November 27, 2013 |newspaper=GenomeWeb Daily News |date=May 10, 2012}}</ref>

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,<ref name=Herper/><ref name=PRDec5/><ref name=Fung/> when it announced that it would resume providing health information in the form of carrier status and wellness reports with FDA approval.<ref name="arstechnica">{{Cite web |title = 23andMe reboots genetic health testing, now with FDA approval |url = https://arstechnica.com/science/2015/10/23andme-reboots-genetic-health-testing-now-with-fda-approval/ |website = Ars Technica |access-date = October 21, 2015 |date = 2015-10-21}}</ref>

The price of the full direct-to-consumer testing service in the US reduced from $999 in 2007 to $399 in 2008<ref>{{cite news |url=https://www.nytimes.com/2008/09/09/business/09gene.html |last=Pollack |first=Andrew |title=DNA Profile Provider Is Cutting Its Prices |date=September 9, 2008 |work=The New York Times |access-date=December 27, 2017}}</ref> and to $99 in 2012,<ref name="Tsotsis">{{cite web |last=Tsotsis |first=Alexia |title=Another $50M Richer, 23andMe Drops Its Price To $99 Permanently. But Will The Average Dude Buy In? |date=December 11, 2012 |url=https://techcrunch.com/2012/12/11/23andnotme/ |work=TechCrunch |publisher=AOL |access-date=December 12, 2012}}</ref> and was effectively being sold as a [[Finance:Loss leader|loss leader]] in order to build a valuable customer database.<ref name=Jeffries/><ref>{{cite news |last1=Hamilton |first1=David |title=23andMe's Price Cut: The End of Personal Genomics? |url=http://www.cbsnews.com/news/23andmes-price-cut-the-end-of-personal-genomics/ |access-date=July 17, 2014 |work=CBSNews.com |date=September 10, 2008 |archive-url=https://web.archive.org/web/20140717122727/http://www.cbsnews.com/news/23andmes-price-cut-the-end-of-personal-genomics/ |archive-date=July 17, 2014 |url-status=live}}</ref><ref>{{cite news |last1=Krol |first1=Aaron |title=23andMe Pursues Health Research in the Shadow of the FDA |url=http://www.bio-itworld.com/BioIT_Article.aspx?id=136445 |access-date=July 17, 2014 |work=Bio-IT World |date=March 24, 2014 |archive-url=https://web.archive.org/web/20140806215135/http://www.bio-itworld.com/BioIT_Article.aspx?id=136445 |archive-date=August 6, 2014 |url-status=live }}</ref> In October 2015, the US price was raised to $199.<ref name=arstechnica/> 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.<ref>{{cite news |last1=Ramsey |first1=Lydia |title=23andMe is now offering a $99 genetics test again – but it's very different from the original |url=http://www.businessinsider.com/23andme-99-ancestry-test-2016-9 |access-date=September 26, 2016 |work=Business Insider |date=September 22, 2016}}</ref>

The initial price of the product sold in Canada from October 2014, which includes health-related results, was {{CAD|99}}.<ref name=Ubelacker/><ref name=Hansen/> The initial price of the product sold in the UK from December 2014, which includes health-related results, was £125.<ref>{{cite news |last1=Gibbs |first1=Samuel |title=DNA-screening test 23andMe launches in UK after US ban |url=https://www.theguardian.com/technology/2014/dec/02/google-genetic-testing-23andme-uk-launch |access-date=October 26, 2015 |work=The Guardian |date=December 2, 2014}}</ref>

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 [[Organization:National Institutes of Health|National Institutes of Health]]) will rectify by recruiting [[Place:Sub-Saharan Africa|sub-Saharan Africa]]ns to increase the genomic data on racial and ethnic minorities.<ref>{{Cite news |url=https://www.cnbc.com/2018/02/28/23andme-adds-120-new-regions-to-its-ancestry-test.html |title=23andMe is getting more specific with its DNA ancestry tests, adding 120 new regions |last=Farr |first=Christina |date=February 28, 2018 |work=CNBC |access-date=March 29, 2018}}</ref><ref>Hayden, Erika Check. [https://www.nature.com/news/the-rise-and-fall-and-rise-again-of-23andme-1.22801 "The rise and fall and rise again of 23andMe"], ''Nature'', October 11, 2017. Retrieved April 21, 2018.</ref> 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.<ref>Zhang, Sarah. [https://www.theatlantic.com/science/archive/2018/04/23andme-diversity-dna/558575/ "23andMe Wants Its DNA Data to Be Less White"], ''The Atlantic'', April 23, 2018.</ref>

====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 analysis techniques|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.<ref>{{cite web |url=https://blog.23andme.com/news/inside-23andme/23andmeplus/ |title=23andMe+: An ongoing approach to your genetics |date=October 1, 2020}}</ref>

====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.<ref>{{Cite news |date=2021-10-21 |title=23andMe to buy telehealth firm Lemonaid for $400 mln |language=en |work=Reuters |url=https://www.reuters.com/business/healthcare-pharmaceuticals/23andme-buy-telehealth-firm-lemonaid-400-mln-2021-10-22/ |access-date=2022-03-21}}</ref><ref>{{Cite web |date=2021-10-22 |title=23andMe snaps up prescription platform Lemonaid Health for $400M |url=https://www.mobihealthnews.com/news/23andme-snaps-prescription-platform-lemonaid-health-400m |access-date=2022-03-21 |website=MobiHealthNews |language=en}}</ref><ref>{{Cite web |last=HealthLeaders |title=23andMe Will Spend $400M to Acquire Lemonaid Health |url=https://www.healthleadersmedia.com/telehealth/23andme-will-spend-400m-acquire-lemonaid-health |access-date=2022-03-21 |website=www.healthleadersmedia.com |language=en}}</ref>

===Instrument and chip versions===
Up until 2010, [[Company:Illumina|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.<ref>{{cite news|last1=Petrone|first1=Justin|title=FDA Clears Illumina's BeadXpress System for Clinical Use|url=https://www.genomeweb.com/arrays/fda-clears-illuminas-beadxpress-system-clinical-use|work=GenomeWeb|date=May 4, 2010|language=en}}</ref><ref>{{cite web|title=510(k) Premarket Notification K093128|url=https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K093128|publisher=FDA|access-date=April 7, 2017}}</ref>

== 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 is ongoing and has not been peer-review<nowiki/>ed.<ref>{{Cite web |first=Hannah |last=Kuchler |title=Study links blood type to lower risk of catching coronavirus |publisher=Financial Times |date=2020-06-08 |url=https://www.ft.com/content/587de199-add0-41d9-992e-8f329f8db047 |access-date=2020-06-09}}</ref><ref>{{Cite web |first=Kristen V |last=Brown |title=23andMe Provides More Evidence That Blood Type Plays Role in Virus |website=Bloomberg |date=2020-06-08 |url=https://www.bloomberg.com/news/articles/2020-06-08/23andme-provides-more-evidence-that-blood-type-plays-role-in-virus |access-date=2020-06-09}}</ref><ref>{{Cite news |title=23andMe provides more evidence that blood type plays role in COVID-19 virus |url=https://gulfnews.com/world/23andme-provides-more-evidence-that-blood-type-plays-role-in-covid-19-virus-1.1591635107796 |access-date=2020-06-09 |website=gulfnews.com |language=en}}</ref>

==Informed consent and privacy concerns==
Questions have been raised since at least 2013 as to whether the company can obtain [[Philosophy:Informed consent|informed consent]] through its web-based interactions with people who want to submit samples for [[Biology:Sequencing|sequencing]].<ref name="Stoekle2016">{{cite journal |last1=Stoeklé |first1=HC |last2=Mamzer-Bruneel |first2=MF |last3=Vogt |first3=G |last4=Hervé |first4=C |title=23andMe: a new two-sided data-banking market model. |journal=BMC Medical Ethics |date=March 31, 2016 |volume=17 |pages=19 |doi=10.1186/s12910-016-0101-9 |pmid=27059184 |pmc=4826522 |doi-access=free }}</ref><ref>{{cite journal |last1=Allyse |first1=M |title=23 and Me, We, and You: direct-to-consumer genetics, intellectual property, and informed consent|journal=Trends in Biotechnology |date=February 2013 |volume=31 |issue=2 |pages=68–69 |doi=10.1016/j.tibtech.2012.11.007 |pmid=23237855|pmc=6309979 }}</ref>

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, [[HTTP cookie|cookies]], and through its smartphone app.<ref name=":0">{{Cite web|url=https://www.23andme.com/about/privacy/|title=Privacy Policy|date=17 July 2018|website=23andMe}}</ref><ref>{{Cite news|url=https://www.cbsnews.com/news/dna-privacy-at-home-tests-23andme-ancestrydna-sell-data-to-third-parties/|title=Behind at-home DNA testing companies sharing genetic data with third parties|date=2 August 2018|work=CBS News}}</ref> 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, pharmaceutical companies, advertising companies, biotechnology companies, law enforcement, or other interested parties.<ref>{{Cite web|url=https://gizmodo.com/23andme-is-selling-your-data-but-not-how-you-think-1794340474|title=23andMe Is Selling Your Data, But Not How You Think|last=Brown|first=Kristen|date=17 April 2017|website=Gizmodo|access-date=1 May 2019}}</ref><ref>{{cite news |last1=Drabiak |first1=Katherine |title=Read the Fine Print Before Sending Your Spit to 23andMe |url=https://www.thehastingscenter.org/response-to-call-for-essays-read-the-fine-print-before-sending-your-spit-to-23andme-r/ |work=The Hastings Center |date=February 26, 2016}}</ref><ref name=":1">{{Cite web|url=https://www.businessinsider.com/dna-testing-ancestry-23andme-share-data-companies-2018-8|title=DNA-testing companies like 23andMe sell your genetic data to drugmakers and other Silicon Valley startups|last=Brodwin|first=Erin|date=3 August 2018|website=Business Insider}}</ref> People may not actually be aware of how the company uses the data, and there are always risks of [[Data breach|data breach]]es.<ref>{{cite news |last1=Schulson |first1=Michael |title=Spit and Take |url=http://www.slate.com/articles/technology/future_tense/2017/12/direct_to_consumer_genetic_testing_has_tons_of_privacy_issues_why_is_the.html |work=Slate |date=December 29, 2017}}</ref><ref name=":2">{{Cite web|url=https://www.forbes.com/sites/realspin/2017/02/15/the-privacy-delusions-of-genetic-testing/#5d0a7c431bba|title=The Privacy Delusions Of Genetic Testing|last=Pitts|first=Peter|date=15 February 2017|website=Forbes}}</ref>

===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 [[Medicine:Health Insurance Portability and Accountability Act|Health Insurance Portability and Accountability Act]] (HIPAA).<ref name=":2" /> 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.<ref>{{Cite news |url=https://dnatestingchoice.com/en-us/news/23andme-sell-your-data-should-you-be-worried |title=23andMe sell your data – should you be worried? |last=Wisgard |first=Alex |date=25 January 2019 |publisher=dnatestingchoice.com }}</ref> In addition, 23andMe's privacy policy can be confusing for consumers to understand.<ref>{{Cite news |url=https://www.nbcnews.com/health/health-news/what-you-re-giving-away-those-home-dna-tests-n824776 |title=What you're giving away with those home DNA tests |last=Fox |first=Maggie |date=29 November 2017 |publisher=NBC News }}</ref> Despite confusion, 23andMe’s informed consent practices are IRB-approved. Several sections of the privacy policy allows data to be disclosed to third parties, regardless whether the consent is signed:

<blockquote>
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."<ref name=":0" />
</blockquote>
<blockquote>
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."<ref>{{Cite web |url=https://customercare.23andme.com/hc/en-us/articles/202907870-Will-the-information-I-provide-be-shared-with-third-parties- |title=Will the information I provide be shared with third parties? |publisher=23andMe |access-date=1 May 2019}}</ref> </blockquote>
<blockquote>
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."<ref name=":0" />
</blockquote>

The [[Medicine:Genetic Information Nondiscrimination Act|Genetic Information Nondiscrimination Act]] (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 as of 25 May 2018, 23andMe must abide by the [[General Data Protection Regulation]] (GDPR).<ref>{{Cite web|url=https://www.23andme.com/gdpr/|title=Data Protection - GDPR|website=23andMe}}</ref><ref name=":3">{{Cite web|url=https://ec.europa.eu/commission/sites/beta-political/files/data-protection-overview-citizens_en.pdf|title=It's your Data - Take Control: Data Protection in the EU|date=2018|website=European Commission|access-date=1 May 2019}}</ref> 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.<ref name=":3" />  The regulation also applies to companies who offer products/services outside of the EU.<ref name=":3" />

===Medical research===
Over 80% of 23andMe customers have opted in to having their data used in research.<ref>{{Cite web|url=https://www.fastcompany.com/3040356/what-23andme-is-doing-with-all-that-dna|title=How 23andMe is Monetizing Your DNA|date=January 5, 2015}}</ref><ref>{{Cite web|url=https://www.theguardian.com/commentisfree/2020/feb/16/dna-hugely-valuable-health-tech-privacy|title = Your DNA is a valuable asset, so why give it to ancestry websites for free? &#124; Laura Spinney|website = TheGuardian.com|date = February 16, 2020}}</ref>
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 [[Medicine:Pharmaceutical industry|pharmaceutical]] and [[Engineering:Biotechnology|biotechnology]] companies for use in their research.<ref name="Pollack" /><ref name="Jeffries" /><ref>{{cite news|last1=McBride|first1=Ryan|title=23andMe sets stage for stronger ties with pharma|url=http://www.fiercebiotech.com/story/23andme-sets-stage-stronger-ties-pharma/2012-11-29|access-date=July 17, 2014|work=FierceBiotech|date=November 29, 2012|archive-url=https://web.archive.org/web/20130808172154/http://www.fiercebiotech.com/story/23andme-sets-stage-stronger-ties-pharma/2012-11-29|archive-date=August 8, 2013|url-status=live}}</ref> The company also collaborates with academic and government scientists.<ref name="Wired2010">{{cite magazine|url=https://www.wired.com/magazine/2010/06/ff_sergeys_search/all/1|title=Sergey Brin's Search for a Parkinson's Cure |issue=7 |last=Goetz|first=Thomas|date=June 22, 2010|access-date=April 5, 2012|magazine=Wired|volume=18 |archive-url=https://web.archive.org/web/20140717095539/http://www.wired.com/2010/06/ff_sergeys_search/all/1|archive-date=July 17, 2014|url-status=live}}</ref><ref name="Kiss" /> In July 2012, 23andMe acquired the startup CureTogether, a crowdsourced treatment ratings website with data on over 600 medical conditions.<ref>{{Cite web|url = https://techcrunch.com/2012/07/11/23andme-first-acquisition//|title = 23andMe Makes First Acquisition, Nabs CureTogether To Double Down On Crowdsourced Genetic Research = Jul 11, 2012|access-date = Feb 18, 2015|website = TechCrunch| date=July 11, 2012 }}</ref>  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.<ref name=":0" /><ref name=":1" />

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 [[Biology:Glucocerebrosidase|glucocerebrosidase]] as a risk factor for Parkinson's disease.<ref name="Wired2010" />

In 2015, 23andMe made a business decision to pursue [[Medicine:Drug discovery|drug discovery]] themselves, under the direction of former [[Company:Genentech|Genentech]] executive Richard Scheller.<ref name=Pollack/><ref>{{cite news|last1=Herper|first1=Matthew|title=In Big Shift, 23andMe Will Invent Drugs Using Customer Data|url=https://www.forbes.com/sites/matthewherper/2015/03/12/23andme-enters-the-drug-business-just-as-apple-changes-it/|access-date=October 28, 2015|work=Forbes|date=March 12, 2015}}</ref> 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 [[Company:Pfizer|Pfizer]] to explore the genetic causes of [[Medicine:Inflammatory bowel disease|inflammatory bowel disease]], namely [[Medicine:Ulcerative colitis|ulcerative colitis]] and [[Medicine:Crohn's disease|Crohn's disease]].<ref>{{cite news|last1=Herper|first1=Matthew|title=Surprise! With $60 Million Genentech Deal, 23andMe Has A Business Plan|url=https://www.forbes.com/sites/matthewherper/2015/01/06/surprise-with-60-million-genentech-deal-23andme-has-a-business-plan/#442bc3e52be9|work=Forbes|date=January 6, 2015|language=en}}</ref><ref>{{cite magazine|last1=Molten|first1=Megan|title=23andMe Is Digging Through Your Data for a Parkinson's Cure|url=https://www.wired.com/story/23andme-is-digging-through-your-data-for-a-parkinsons-cure|magazine=Wired|date=September 13, 2017}}</ref>

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.<ref>Pressman, Aaron. [http://fortune.com/2016/10/27/23andme-killed-next-generation-gene-sequencing/ "Why 23andme Killed Its Next Generation Gene Sequencing Project"], ''Fortune'', October 27, 2016. Retrieved April 17, 2018.</ref> Also in 2016, 23andMe used self-reported data from customers to locate 17 genetic [[Biology:Locus (genetics)|loci]] that seem to be associated with [[Medicine:Depression (mood)|depression]].<ref>{{cite journal|last1=Mullins|first1=N|last2=Lewis|first2=CM|title=Genetics of Depression: Progress at Last.|journal=Current Psychiatry Reports|date=August 2017|volume=19|issue=8|pages=43|doi=10.1007/s11920-017-0803-9|pmid=28608123|pmc=5486596}}</ref>

In 2017, 23andMe, the Lundbeck pharmaceutical company, and the Milken Institute think tank started collaborations to focus on psychiatric disorders, such as [[Medicine:Bipolar disorder|bipolar disorder]] and major depression. Their goals are to determine the genetic roots of such disorders, as well as pursue drug discovery in those areas.<ref name="Fortune2017">{{cite news|last1=Mukherjee|first1=Sy|title=23andMe Raises Another $250 Million – And Wants to Use Your Genetic Data to Make Drugs|url=http://fortune.com/2017/09/12/23andme-250-million-sequoia-drugs/?iid=sr-link9|work=Fortune|date=September 12, 2017|language=en}}</ref>

===Use by law enforcement===
23andMe reports in their annual transparency report that they have received requests from law enforcement for only 15 users' data since 2015 as of November 2023.<ref name=":4">{{Cite web |url=https://www.23andme.com/transparency-report/ |title=Transparency Report |date=November 10, 2023 |website=23andMe }}</ref> 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".<ref>{{Cite web |url=https://www.23andme.com/legal/privacy/full-version/|title=Privacy Statement |website=23andMe |access-date=1 Feb 2024}}</ref>

=== 2023 data leak ===

In October 2023, a data breach occurred and sensitive information of 23AndMe users was stolen. The company claimed that it was a [[Credential stuffing|credential stuffing]] incident rather than a breach into their systems. The hackers targeted Ashkenazi Jews 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.<ref>{{Cite web |title=Genetics firm 23andMe says user data stolen in credential stuffing attack |url=https://www.bleepingcomputer.com/news/security/genetics-firm-23andme-says-user-data-stolen-in-credential-stuffing-attack/ |access-date=2023-10-06 |website=BleepingComputer |language=en-us}}</ref><ref>{{Cite magazine |last=Newman |first=Lily Hay |date=October 6, 2023 |title=23andMe User Data Stolen in Targeted Attack on Ashkenazi Jews |url=https://www.wired.com/story/23andme-credential-stuffing-data-stolen/ |magazine=Wired}}</ref>

== See also ==
* [[Biology:Genographic Project|Genographic Project]]

== References ==
{{Reflist}}

==Further reading<!-- If these can be incorporated into the article as citations, that would be a good reason to remove from this listing. -->==
* [http://www.technologyreview.com/view/534006/23andmes-new-formula-patient-consent/ 23andMe’s New Formula: Patient Consent].  Antonio Regalado, ''MIT Technology Review''

==External links==
{{Finance links
| name = 23andMe Holding Co.
| symbol = ME
| reuters = ME.O
| bloomberg = ME:US
| sec_cik = 1414053
| yahoo = ME
| google = ME:NASDAQ
}}

{{Genealogical DNA test}}


{{DEFAULTSORT:23andme}}
[[Category:Applied genetics]]
[[Category:Biological databases]]
[[Category:Companies (Biology)]]
[[Category:Companies]]

{{Sourceattribution|23andMe}}