|Founders||Linda Avey, Paul Cusenza and Anne Wojcicki|
|Headquarters||Mountain View, California, United States|
|Number of locations||2|
|Key people||Anne Wojcicki, CEO
Esther Dyson, board member
|Products||DTC personal genome test|
|Services||Genetic testing, medical research|
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. Its saliva-based direct-to-consumer (DTC) personal genome test was named Invention of the Year by Time magazine in 2008. In 2013 the US Food and Drug Administration (FDA) ordered 23andMe to discontinue marketing its personal genome service as the company had not obtained the legally required regulatory approval resulting in concerns about the potential consequences of customers receiving inaccurate health results. The company still sells a personal genome test without health-related results in the United States, and from October 2014 is selling a product with both ancestry and health-related components in Canada.
Products and services
DTC genetic testing
23andMe began offering DTC genetic testing in November 2007. Customers provide a saliva testing sample that is partially SNP genotyped and results are posted online. 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.
Uninterpreted raw genetic data is posted online and may be downloaded by customers. Customers who bought tests with an ancestry-related component have online access to genealogical DNA test results and tools including a relative matching database. Customers who bought tests with a health-related component and received health-related results before November 22, 2013, and Canadians who bought the product from November 22, 2013, have online access to an assessment of inherited traits and genetic disorder risks. Health-related results for non-Canadian customers who purchased the test from November 22, 2013 have been suspended while undergoing an FDA regulatory review.
In late 2009 23andMe split its genotyping service into three products with different prices, an Ancestry Edition, a Health edition, and a Complete Edition. This decision was reversed a year later when the different products were recombined. In late 2010 the company introduced a monthly subscription fee for updates based on new medical research findings. The subscription model proved unpopular with customers and was eliminated in mid-2012. As of December 5, 2013, 23andMe is only selling raw genetic data and ancestry-related results in the United States.
The price of the full DTC testing service in the United States has reduced from $999 in 2007 to $99 in 2012, and it is effectively being sold as a loss leader in order to build a valuable customer database.
Aggregated customer data is studied by scientific researchers employed by 23andMe in order to better understand inherited disorders. The large pool of data in its customer database has also attracted the interest of academics and other partners, including pharmaceutical and biotechnology companies.
23andMe provides services related to some specific medical research initiatives, providing confidential customer datasets to and partnering with researchers to establish genetic associations with specific illnesses and disorders. 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, although in much less time. They have begun enrolling patients into research communities to study the genetics of: African-Americans, Inflammatory Bowel Disease, myeloproliferative neoplasms (MPNs) and sarcoma. Research has been presented at American Society of Human Genetics meetings.
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. 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.
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. By August 2008, 23andMe had received licenses that allow them to continue to do business in California.
According to Anne Wojcicki, 23andMe has been in dialogue with the FDA since 2008. 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. 23andMe first submitted applications for FDA clearance in July and September 2012. 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". As of December 2, 2013, 23andMe has stopped all advertisements for its PGS test but is still selling the product. As of December 5, 2013, 23andMe is only selling raw genetic data and ancestry-related results.
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. 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." 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. TechFreedom promoted a petition asking the FDA not to ban 23andMe's home genome testing kits. 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."
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." 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."
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.
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. From October 2014, 23andMe is selling a product with both ancestry and health-related components in Canada.
Class action lawsuits
On November 27, 2013, 23andMe customer Lisa Casey filed a class action lawsuit against 23andMe in the Southern California federal district court for misleading advertising of its PGS test "when there is no analytical or clinical validation for the PGS for its intended uses". Casey is suing for at least $5 million in damages, representing the aggregate of the $99 PGS test purchase price paid by thousands of customers the plaintiff believes to be in the class.
- "Fact Sheet". 23andMe. Retrieved November 27, 2013.
- Hamilton, Anita (October 29, 2008). "Best Inventions of 2008". Time. Retrieved April 5, 2012.
- "Inspections, Compliance, Enforcement, and Criminal Investigations – 23andMe, Inc. 11/22/13". FDA. November 22, 2013. Retrieved November 25, 2013.
- 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.
- 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.
- 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.
- "23andme genetic testing service raises ethical questions". CBC News. October 2, 2014. Retrieved October 7, 2014.
- 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.
- "Corporate Info". 23andMe. Retrieved November 27, 2013.
- "Board Of Directors". Nodal Exchange. Retrieved November 27, 2013.
- Curious: We've got questions
- "Our Service: Genotyping Technology". 23andMe. Retrieved November 27, 2013.
- Hadly, Scott (November 18, 2013). "23andMe's New Custom Chip". 23andMe. Retrieved November 27, 2013.
- 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.
- 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.
- 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.
- "23andMe, Inc. provides update on FDA regulatory review" (Press release). 23andMe. December 5, 2013. Retrieved December 6, 2013.
- Fung, Brian (December 6, 2013). "Bowing again to the FDA, 23andMe stops issuing health-related genetic reports". The Washington Post. Retrieved December 6, 2013.
- 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.
- Picard, André (October 2, 2014). "Controversial genetic self-testing kits coming to Canada". The Globe and Mail. Retrieved October 7, 2014.
- Wu, Shirley (November 13, 2009). "Get Just the Information You Want: 23andMe To Offer Separate Health and Ancestry Editions". 23andMe. Retrieved November 29, 2013.
- 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.
- 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.
- "23andMe Eliminates Subscription Model". GenomeWeb Daily News. May 10, 2012. Retrieved November 27, 2013.
- 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.
- 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.
- 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.
- 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.
- "23andWe Research". 23andMe. Retrieved April 5, 2012.
- 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.
- "Google invests in genetics firm". BBC News. May 22, 2007. Retrieved June 28, 2007.
- "Press Release: 23andMe Raises More Than $50 Million in New Financing". 23andMe. December 11, 2012. Retrieved November 27, 2013.
- "23andMe". CrunchBase. AOL. Retrieved December 12, 2012.
- 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."
- Wojcicki, Anne (November 26, 2013). "An Update Regarding The FDA's Letter to 23andMe". 23andMe. Retrieved November 27, 2013.
- Robert Langreth and Matthew Herper (April 18, 2008). "States Crack Down On Online Gene Tests". Forbes.
- Jason Kincaid (June 18, 2008). "Cease And Desist: California Tries to Unravel 23andMe's Genetic Testing". The Washington Post (TechCrunch.com).
- Pollack, Andrew (August 20, 2008). "California Licenses 2 Companies to Offer Gene Services". The New York Times.
- "FDA cracking down on genetic tests". NBC. June 11, 2010. Retrieved November 27, 2013.
- Perrone, Matthew (November 25, 2013). "FDA Tells 23andMe to Halt Sales of Genetic Test". ABC News. Retrieved November 25, 2013.
- 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.
- Garde, Damian (December 3, 2013). "23andMe pulls ads after FDA warning, but sales roll on". FierceMedicalDevices. FierceMarkets. Retrieved December 4, 2013.
- del Castillo, Michael (December 3, 2013). "Calm down about 23andMe, the media is getting it wrong". Upstart Business Journal. Retrieved December 5, 2013.
- 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.
- Bailey, Ronald (November 25, 2013). "FDA Shuts Down 23andMe: Outrageously Banning Consumer Access to Personal Genome Information". Reason Magazine. Retrieved November 25, 2013.
- Lee, Timothy B. (November 25, 2013). "The FDA should leave 23andMe alone". Washington Post. Retrieved November 25, 2013.
- Herper, Matthew (November 25, 2013). "23andStupid: Is 23andMe Self-Destructing?". Forbes. Retrieved November 26, 2013.
- 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.
- Young, Susan (November 25, 2013). "Updated: FDA Orders 23andMe to Stop Genetic Tests". Technology Review. Retrieved November 25, 2013.
- 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.
- Munro, Dan (December 2, 2013). "Class Action Law Suit Filed Against 23andMe". Forbes. Retrieved December 5, 2013.
- Garde, Damian (December 3, 2013). "23andMe hit with lawsuit over 'meaningless' gene tests". FierceMedicalDevices. FierceMarkets. Retrieved December 4, 2013.
- Perrone, Matthew (December 3, 2013). "23andMe faces class action lawsuit in California". The Associated Press. Retrieved December 5, 2013.
- Convey, Eric (December 19, 2013). "Women sue 23andMe over marketing claims". Boston Business Journal. American City Business Journals. Retrieved December 20, 2013.