|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||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. 23andMe has been selling a product with both ancestry and health-related components in Canada since October 2014, and in the United Kingdom since December 2014.
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. 23andMe has launched research initiatives enrolling patients into study populations for inflammatory bowel disease and myeloproliferative neoplasms. Papers on various genetic traits by 23andMe scientists were presented at the 2014 American Society of Human Genetics.
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. 23andMe has been selling a product with both ancestry and health-related components in Canada since October 2014, and in the United Kingdom since December 2014.
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.
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