2006 founders linda avey paul cusenza and anne wojcicki headquarters mountain view california united states number of locations 3 key people anne wojcicki ceo esther dyson board member products direct to consumer personal genome testing services genetic testing medical research website www.23andme.com 23andme is a privately held personal genomics and biotechnology company based in mountain view california . the company is named for the 23 pairs of chromosomes in a normal human cell . 1 its saliva based direct to consumer personal genome test was named invention of the year by time magazine in 2008 . 2 in 2013 the us food and drug administration fda ordered 23andme to discontinue marketing its personal genome service pgs as the company had not obtained the legally required regulatory approval resulting in concerns about the potential consequences of customers receiving inaccurate health results . 3 the company continued to sell a personal genome test without health related results in the united states until october 21 2015 when it announced that it would be including a revised health component with fda approval . 4 5 23andme has been selling a product with both ancestry and health related components in canada since october 2014 6 7 8 and in the united kingdom since december 2014 . 9 contents 1 company history 2 products and services 2.1 direct to consumer genetic testing 2.1.1 product changes 2.1.1.1 chip versions 2.2 medical research 3 relationship with government regulators 3.1 state regulators 3.2 fda 4 class action lawsuits 5 references 6 further reading company history edit the company was founded by linda avey paul cusenza and anne wojcicki in 2006 to provide genetic testing and interpretation to individual consumers . 10 11 in 2007 google invested 3 900 000 in the company along with genentech new enterprise associates and mohr davidow ventures . 12 cusenza left the company in 2007 and was appointed ceo of nodal exchange in 2008 . 13 avey left the company in 2009 and co founded curious inc. in 2011 . 14 in 2012 23andme raised 50 million in a series d venture round almost doubling its existing capital of 52.6 million . 15 16 17 in 2015 23andme raised 115 million in a series e offering increasing its total capital to 241 million . 5 18 19 the company sponsored the pbs tv series 9 months that made you . 20 the company had not turned a profit as of october 2015 update . 5 products and services edit direct to consumer genetic testing edit 23andme began offering direct to consumer genetic testing in november 2007 . customers provide a saliva testing sample that is partially snp genotyped and results are posted online . 10 21 22 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 . 2 uninterpreted raw genetic data is posted online and may be downloaded by customers . 23 customers who bought tests with an ancestry related component have online access to genealogical dna test results and tools including a relative matching database . us customers who bought tests with a health related component and received health related results before november 22 2013 have online access to an assessment of inherited traits and genetic disorder risks . 4 24 25 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 . 5 26 27 customers who bought tests from 23andme s canadian and uk locations have access to some health related results . 6 9 as of june 2015 23andme has genotyped over 1 000 000 individuals . 28 29 fda marketing restrictions have reduced customer growth . 30 product changes edit in late 2009 23andme split its genotyping service into three products with different prices an ancestry edition a health edition and a complete edition . 31 this decision was reversed a year later when the different products were recombined . 32 in late 2010 the company introduced a monthly subscription fee for updates based on new medical research findings . 32 33 the subscription model proved unpopular with customers and was eliminated in mid 2012 . 34 23andme only sold raw genetic data and ancestry related results in the united states due to fda restrictions from november 22 2013 until october 21 2015 4 26 27 when it announced that it would resume providing health information in the form of carrier status and wellness reports with fda approval . 35 wojcicki said they still plan to report on disease risk subject to future fda approval . 5 the price of the full direct to consumer testing service in the united states reduced from 999 in 2007 to 99 in 2012 15 and was effectively being sold as a loss leader in order to build a valuable customer database . 23 36 37 in october 2015 the us price was raised to 199 . 35 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 . 38 the price for international customers was lowered from 199 to 149 . to date this kit offers only ancestry information 39 the initial price of the product sold in canada from october 2014 which includes health related results was c 199 . 6 7 the initial price of the product sold in the uk from december 2014 which includes health related results was 125 . 40 chip versions edit chip version introduced 41 illumina beadchip platform used snps genotyped approximate v1 november 2007 illumina 4 sample humanhap550 plus 576 000 v2 september 2008 illumina 4 sample humanhap550 plus 597 000 v3 november 2010 illumina 12 sample humanomniexpress plus 992 000 v4 november 2013 illumina 24 sample hts iselect hd 611 000 medical research edit aggregated customer data is studied by scientific researchers employed by 23andme for research on inherited disorders . the large pool of data in its customer database has also attracted the interest of academics and other partners 30 including pharmaceutical and biotechnology companies . 23 42 in july 2012 23andme acquired the startup curetogether a crowdsourced treatment ratings website with data on over 600 medical conditions . 43 23andme provides services related to some specific medical research initiatives 44 providing confidential customer datasets to and partnering with researchers to establish genetic associations with specific illnesses and disorders . 10 one analysis comparing 23andme s parkinson s disease research with a national institutes of health initiative suggested that the company s use of large amounts of computational power and datasets might offer comparable results in much less time . 45 23andme has launched research initiatives enrolling patients into study populations for inflammatory bowel disease myeloproliferative neoplasms and lupus . 46 47 papers on various genetic traits by 23andme scientists were presented at the 2014 american society of human genetics . 48 in 2015 23andme made a business decision to pursue drug development themselves under the direction of former genentech executive richard scheller as opposed to supplying pharmaceutical companies with raw data . 5 49 relationship with government regulators edit the new genetic testing service and ability to map significant portions of the genome has raised controversial questions including whether the results can be interpreted meaningfully and whether they will lead to genetic discrimination . 2 23 the regulatory environment for testing companies has been uncertain and anticipated risk based regulation catering for different types of genetic tests has not yet materialized . 32 50 51 state regulators edit in 2008 it was reported that the states of new york and california unsuccessfully attempted to block such tests provided by 23andme as well as other companies under the grounds that they were not properly licensed and attempted to require tests to be conducted only when ordered by a physician . 2 52 53 by august 2008 23andme had received licenses that allow them to continue to do business in california . 54 fda edit according to anne wojcicki 23andme has been in dialogue with the fda since 2008 . 51 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 . 32 55 23andme first submitted applications for fda clearance in july and september 2012 . 3 on november 22 2013 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 the fda is concerned about the public health consequences of inaccurate results from the pgs device . 3 56 57 as of december 2 2013 23andme has stopped all advertisements for its pgs test but is still selling the product . 58 59 as of december 5 2013 23andme is only selling raw genetic data and ancestry related results . 4 26 27 according to science writer razib khan this development ultimately will not matter as raw genetic results can be obtained cheaply from international genome sequencing firms and open source tools to analyse such data using published scientific research are freely available . 60 ronald bailey writes in reason magazine the fda bureaucrats think that they know better than you how to handle your genetic information . this is outrageous . 61 technology writer timothy b. lee argues in the washington post against the fda preventing consumer access to personal health information provided by 23andme stating that any risky medical decisions patients made based on 23andme s services would require the involvement of licensed medical professionals . 62 techfreedom promoted a petition asking the fda not to ban 23andme s home genome testing kits . 61 science and medicine writer matthew herper was more critical of 23andme writing in forbes magazine the fda probably felt it had little choice . this is not the story of a big regulator choosing to squash a small company but of a company that decided that it didn t have to follow the rules . 63 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 . 60 64 65 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 . 51 on december 5 2013 23andme announced that it has 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 . 4 26 27 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 . 66 23andme has been selling a product with both ancestry and health related components in canada since october 2014 6 7 8 and in the united kingdom since december 2014 . 9 on february 19 2015 the fda announced that it had approved a 23andme test for bloom syndrome . 67 on october 21 2015 23andme announced that it would