23andMe

23andMe, Inc.
Private
Industry Biotechnology
Founded April 2006 (2006-04)
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 genetic testing business 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. That resulted 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]

Company history

The company was founded by Linda Avey, Paul Cusenza and Anne Wojcicki, ex-wife of Google founder Sergey Brin, 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.[5]

Products and services

Direct to consumer genetic testing

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 reduced customer growth rates[30] but by 2017 they had tested 2,000,000 individuals.[31]

As of April 2017, FDA allowed marketing of 23andMe Personal Genome Service Genetic Health Risk (GHR) tests for 10 diseases or conditions. These are the first direct-to-consumer (DTC) tests authorized by the FDA that provide information on an individual’s genetic predisposition to certain medical diseases or conditions, which may help to make decisions about lifestyle choices or to inform discussions with a health care professional.[32]

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.[33] This decision was reversed a year later when the different products were recombined.[34] In late 2010 the company introduced a monthly subscription fee for updates based on new medical research findings.[34][35] The subscription model proved unpopular with customers and was eliminated in mid-2012.[36]

23andMe sold only 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.[37] 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][38][39] In October 2015, the US price was raised to $199.[37] 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.[40] The price for international customers was lowered from $199 to $149. To date this kit offers only ancestry information.[41]

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.[42]

Instrument and chip versions

Up until 2010 Illumina sold only 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.[43][44]

Chip version Introduced[45] 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

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][46] In July 2012, 23andMe acquired the startup CureTogether, a crowdsourced treatment ratings website with data on over 600 medical conditions.[47]

23andMe provides services related to some specific medical research initiatives,[48] 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.[49] 23andMe has launched research initiatives enrolling patients into study populations for inflammatory bowel disease, myeloproliferative neoplasms, and lupus.[50][51] Papers on various genetic traits by 23andMe scientists were presented at the 2014 American Society of Human Genetics.[52]

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][53]

Relationship with government regulators

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.[34][54][55]

State regulators

In 2008 the states of New York and 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.[2][56][57] By August 2008, 23andMe had received licenses that allow them to continue to do business in California.[58]

FDA

According to Anne Wojcicki, 23andMe had been in dialogue with the FDA since 2008.[55] 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; a similar letter was sent to Illumina, which makes the instruments and chips used by 23andMe in providing its service.[34][59][60] 23andMe first submitted applications for FDA clearance in July and September 2012.[3]

In November 2013, the FDA published a 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.[61]

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 the "FDA is concerned about the public health consequences of inaccurate results from the PGS device".[3][62][63] As of December 2, 2013, 23andMe had stopped all advertisements for its PGS test but is still selling the product.[64][65] As of December 5, 2013, 23andMe was selling only raw genetic data and ancestry-related results.[4][26][27]

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."[66][67][68] 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."[55]

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.[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.[69] 23andMe had 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]

In 2014 23andMe submitted a 510(k) application to the FDA to market a carrier test for 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 would affect the tests, and included citations to the scientific literature showing that the associations between the specific tests that 23andMe were relevant to Blooms.[70][71] 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.[70][72] The FDA sent further clarification about regulation of the test to 23andMe on October 1, 2015.[73]

On October 21, 2015, 23andMe announced that it would begin marketing carrier tests in the US again.[5] CEO Anne 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 CMS.[74]

23andMe submitted de novo 510(k) applications to the FDA to market tests that provide people with information about whether they have gene mutations or alleles that put them at risk for getting or having certain diseases; the applications 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 would affect the tests, and included with citations to the scientific literature showing that the associations between the specific tests that 23andMe were relevant to the diseases. In April 2017, the FDA approved the applications for ten tests: Late-Onset Alzheimer’s Disease, Parkinson’s Disease, Celiac disease, Hereditary Thrombophilia, Alpha-1 Antitrypsin Deficiency, Glucose-6-Phosphate Dehydrogenase deficiency, Early onset of Dystonia, Factor XI deficiency and Gaucher’s Disease.[75][76] The FDA also said that it intended to exempt further 23andMe genetic risk tests from the needing 501(k) applications, and it clarified that it was only approving genetic risk tests, not diagnostic tests.[75]

References

  1. ↑ "Fact Sheet". 23andMe. Retrieved November 27, 2013.
  2. 1 2 3 4 Hamilton, Anita (October 29, 2008). "Best Inventions of 2008". Time. Retrieved April 5, 2012.
  3. 1 2 3 "Inspections, Compliance, Enforcement, and Criminal Investigations – 23andMe, Inc. 11/22/13". FDA. November 22, 2013. Retrieved November 25, 2013.
  4. 1 2 3 4 5 Herper, Matthew (December 5, 2013). "23andMe Stops Offering Genetic Tests Related to Health". Forbes. Archived from the original on February 9, 2014. Retrieved December 6, 2013.
  5. 1 2 3 4 5 6 7 Pollack, Andrew (2015-10-21). "23andMe Will Resume Giving Users Health Data". The New York Times. ISSN 0362-4331. Archived from the original on October 25, 2015. Retrieved 2015-10-21.
  6. 1 2 3 4 Ubelacker, Sheryl (October 1, 2014). "U.S. company launches genetic health and ancestry info service in Canada". Winnipeg Free Press. The Canadian Press. Retrieved October 7, 2014.
  7. 1 2 3 Hansen, Darah (October 2, 2014). "5Q: Anne Wojcicki, CEO 23andMe on knowing your DNA data (and being married to the boss of Google)". Yahoo Finance Canada. Retrieved October 7, 2014.
  8. 1 2 "23andme genetic testing service raises ethical questions". CBC News. October 2, 2014. Retrieved October 7, 2014.
  9. 1 2 3 Roberts, Michelle; Rincon, Paul (2 December 2014). "Controversial DNA test comes to UK". BBC News. Retrieved 2 December 2014.
  10. 1 2 3 Goetz, Thomas (November 17, 2007). "23AndMe Will Decode Your DNA for $1,000. Welcome to the Age of Genomics". Wired. Archived from the original on March 12, 2014. Retrieved April 5, 2012.
  11. ↑ "Corporate Info". 23andMe. Retrieved November 27, 2013.
  12. ↑ "Google invests in genetics firm". BBC News. May 22, 2007. Retrieved June 28, 2007.
  13. ↑ "Board Of Directors". Nodal Exchange. Retrieved November 27, 2013.
  14. ↑ Curious: We've got questions
  15. 1 2 Tsotsis, Alexia (December 11, 2012). "Another $50M Richer, 23andMe Drops Its Price To $99 Permanently. But Will The Average Dude Buy In?". TechCrunch. AOL. Retrieved December 12, 2012.
  16. ↑ "Press Release: 23andMe Raises More Than $50 Million in New Financing". 23andMe. December 11, 2012. Retrieved November 27, 2013.
  17. ↑ "23andMe". CrunchBase. AOL. Retrieved December 12, 2012.
  18. ↑ Chen, Caroline (October 14, 2015). "23andMe Funding Values Genetics Startup at $1.1 Billion". Bloomberg Business. Retrieved October 25, 2015.
  19. ↑ "Notice of Exempt Offering of Securities". U.S. Securities and Exchange Commission. Retrieved 11 July 2015.
  20. ↑ "9 Months That Made You". PBS. Retrieved July 14, 2016.
  21. ↑ "Our Service: Genotyping Technology". 23andMe. Retrieved November 27, 2013.
  22. ↑ Hadly, Scott (November 18, 2013). "23andMe's New Custom Chip". 23andMe. Retrieved November 27, 2013.
  23. 1 2 3 4 Jeffries, Adrianne (December 12, 2012). "Genes, patents, and big business: at 23andMe, are you the customer or the product?". The Verge. Archived from the original on January 2, 2014. Retrieved July 17, 2014.
  24. ↑ Baertlein, Lisa (November 20, 2007). "Google-backed 23andMe offers $999 DNA test". USA Today. Archived from the original on July 17, 2014. Retrieved April 5, 2012.
  25. ↑ Swarns, Rachel L (23 January 2012). "With DNA Testing, Suddenly They Are Family". The New York Times. Archived from the original on July 17, 2014. Retrieved July 17, 2014.
  26. 1 2 3 4 "23andMe, Inc. provides update on FDA regulatory review" (Press release). 23andMe. December 5, 2013. Retrieved December 6, 2013.
  27. 1 2 3 4 Fung, Brian (December 6, 2013). "Bowing again to the FDA, 23andMe stops issuing health-related genetic reports". The Washington Post. Retrieved December 6, 2013.
  28. ↑ Wojcicki, Anne (June 18, 2015). "Power of One Million". Retrieved June 19, 2015.
  29. ↑ Ramsey, Lydia (July 7, 2015). "23andMe CEO defends practice of sharing genetic info with pharma companies". Business Insider. Archived from the original on July 8, 2015. Retrieved July 8, 2015.
  30. 1 2 Kiss, Jemima (March 9, 2014). "23andMe admits FDA order 'significantly slowed up' new customers". The Guardian. Archived from the original on March 16, 2014. Retrieved March 10, 2014.
  31. ↑ "23andMe Breaks Two Million!". The DNA Geek. 2017-04-19. Retrieved 2017-04-24.
  32. ↑ "FDA allows marketing of first direct-to-consumer tests that provide genetic risk information for certain conditions". FDA.
  33. ↑ Wu, Shirley (November 13, 2009). "Get Just the Information You Want: 23andMe To Offer Separate Health and Ancestry Editions". 23andMe. Retrieved November 29, 2013.
  34. 1 2 3 4 Vorhaus, Dan (November 23, 2010). "A Thanksgiving Tradition: 23andMe Repackages Product, Raises Prices". Genomics Law Report. Robinson Bradshaw & Hinson. Archived from the original on December 3, 2013. Retrieved November 29, 2013.
  35. ↑ MacArthur, Daniel (November 24, 2010). "News from 23andMe: a bigger chip, a new subscription model and another discount drive". Wired. Archived from the original on June 29, 2013. Retrieved November 27, 2013.
  36. ↑ "23andMe Eliminates Subscription Model". GenomeWeb Daily News. May 10, 2012. Retrieved November 27, 2013.
  37. 1 2 "23andMe reboots genetic health testing, now with FDA approval". Ars Technica. Retrieved 2015-10-21.
  38. ↑ Hamilton, David (September 10, 2008). "23andMe's Price Cut: The End of Personal Genomics?". CBSNews.com. Archived from the original on July 17, 2014. Retrieved July 17, 2014.
  39. ↑ Krol, Aaron (March 24, 2014). "23andMe Pursues Health Research in the Shadow of the FDA". Bio-IT World. Archived from the original on July 17, 2014. Retrieved July 17, 2014.
  40. ↑ Ramsey, Lydia (September 22, 2016). "23andMe is now offering a $99 genetics test again – but it's very different from the original". Business Insider. Retrieved September 26, 2016.
  41. ↑ https://www.23andme.com/en-int/
  42. ↑ Gibbs, Samuel (December 2, 2014). "DNA-screening test 23andMe launches in UK after US ban". The Guardian. Retrieved October 26, 2015.
  43. ↑ Petrone, Justin (May 4, 2010). "FDA Clears Illumina's BeadXpress System for Clinical Use". GenomeWeb.
  44. ↑ "510(k) Premarket Notification K093128". FDA. Retrieved 7 April 2017.
  45. ↑ "23andMe". isogg.org. Retrieved 9 September 2015.
  46. ↑ McBride, Ryan (November 29, 2012). "23andMe sets stage for stronger ties with pharma". FierceBiotech. Archived from the original on August 8, 2013. Retrieved July 17, 2014.
  47. ↑ "23andMe Makes First Acquisition, Nabs CureTogether To Double Down On Crowdsourced Genetic Research = Jul 11, 2012". TechCrunch. Retrieved Feb 18, 2015.
  48. ↑ "23andWe Research". 23andMe. Retrieved April 5, 2012.
  49. ↑ Goetz, Thomas (June 22, 2010). "Sergey Brin's Search for a Parkinson's Cure". Wired. Archived from the original on July 17, 2014. Retrieved April 5, 2012.
  50. ↑ "People Powered IBD Research". 23andMe blog. 23andMe. October 28, 2014. Retrieved 2014-12-21.
  51. ↑ "23andMe Launches Myeloproliferative Neoplasms Research Initiative". August 3, 2011. Retrieved Dec 21, 2014.
  52. ↑ "Science On the Beach". 23andMe Blog. September 26, 2014. Retrieved Dec 21, 2014.
  53. ↑ Herper, Matthew (March 12, 2015). "In Big Shift, 23andMe Will Invent Drugs Using Customer Data". Forbes. Retrieved 28 October 2015.
  54. ↑ Greely, Hank (November 25, 2013). "The FDA drops an anvil on 23andMe – now what?". Stanford University. Retrieved November 29, 2013. FDA had promised a risk-based regulatory scheme, but we don’t know what it is.
  55. 1 2 3 Wojcicki, Anne (November 26, 2013). "An Update Regarding The FDA's Letter to 23andMe". 23andMe. Retrieved November 27, 2013.
  56. ↑ Robert Langreth; Matthew Herper (April 18, 2008). "States Crack Down On Online Gene Tests". Forbes.
  57. ↑ Jason Kincaid (June 18, 2008). "Cease And Desist: California Tries to Unravel 23andMe's Genetic Testing". The Washington Post. TechCrunch.com.
  58. ↑ Pollack, Andrew (August 20, 2008). "California Licenses 2 Companies to Offer Gene Services". The New York Times.
  59. ↑ "FDA cracking down on genetic tests". NBC. June 11, 2010. Retrieved November 27, 2013.
  60. ↑ Pollack, Andrew (11 June 2010). "F.D.A. Faults 5 Companies on Genetic Tests". The New York Times.
  61. ↑ Malone, Bill (February 1, 2014). "A New Chapter in FDA Regulation - AACC.org". Clinical Laboratory News.
  62. ↑ Perrone, Matthew (November 25, 2013). "FDA Tells 23andMe to Halt Sales of Genetic Test". ABC News. Retrieved November 25, 2013.
  63. ↑ Gray, Tyler (November 25, 2013). "FDA To 23andMe Founder Anne Wojcicki: Stop Marketing $99 DNA Test Or Face Penalties". Fast Company (magazine). Retrieved November 25, 2013.
  64. ↑ Garde, Damian (December 3, 2013). "23andMe pulls ads after FDA warning, but sales roll on". FierceMedicalDevices. FierceMarkets. Retrieved December 4, 2013.
  65. ↑ del Castillo, Michael (December 3, 2013). "Calm down about 23andMe, the media is getting it wrong". Upstart Business Journal. Retrieved December 5, 2013.
  66. ↑ Khan, Razib (November 25, 2013). "The FDA's Battle With 23andMe Won't Mean Anything in the Long Run". Slate Magazine. Retrieved November 25, 2013.
  67. ↑ Etherington, Darrell (November 25, 2013). "DNA Testing Startup 23andMe Hits A Snag As FDA Shuts Down Sales Of Home Testing Kit". TechCrunch. Retrieved November 25, 2013.
  68. ↑ Young, Susan (November 25, 2013). "Updated: FDA Orders 23andMe to Stop Genetic Tests". Technology Review. Retrieved November 25, 2013.
  69. ↑ Farr, Christina (May 6, 2014). "Gene startup 23andme casts eyes abroad after U.S. regulatory hurdle". Reuters. Archived from the original on May 27, 2014. Retrieved July 17, 2014.
  70. 1 2 "FDA permits marketing of first direct-to-consumer genetic carrier test for Bloom syndrome". FDA News Release. February 19, 2015.
  71. ↑ "Device Classification under Section 513(f)(2)(de novo)". www.accessdata.fda.gov. FDA. Retrieved 7 April 2017.. 23andMe's Autosomal Recessive Carrier Screening Gene Mutation Detection System in FDA database
  72. ↑ "23andMe Gets FDA Clearance to Market Bloom Syndrome Carrier Test Directly to Consumers". GenomeWeb. February 19, 2015.
  73. ↑ "Letter re DEN140044" (PDF). FDA. October 1, 2015.. Decision Summary: Evaluation of DEN140044 revising February 2015 evaluation.
  74. ↑ Bensinger, Greg (2016-10-26). "Disconnect Between Silicon Valley and Regulators Over Health Technologies, 23andMe CEO Says". Wall Street Journal. ISSN 0099-9660. Retrieved 2016-11-23.
  75. 1 2 "Press Announcements - FDA allows marketing of first direct-to-consumer tests that provide genetic risk information for certain conditions". FDA. April 6, 2017.
  76. ↑ Kolata, Gina (6 April 2017). "F.D.A. Will Allow 23andMe to Sell Genetic Tests for Disease Risk to Consumers". The New York Times.

Further reading

This article is issued from Wikipedia. The text is licensed under Creative Commons - Attribution - Sharealike. Additional terms may apply for the media files.