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23andMe is a privately held personal genomics and biotechnology company based in Sunnyvale, California. It is best known for providing a direct-to-consumer genetic testing service in which customers provide a saliva sample that is laboratory analysed, using single nucleotide polymorphism genotyping,[2] to generate reports relating to the customer's ancestry and genetic predispositions to health-related topics. The company's name is derived from the fact that there are 23 pairs of chromosomes in a normal human cell.[3]

The company had a previously fraught relationship with the United States Food and Drug Administration (FDA) due to its genetic health tests, but as of October 2015, DNA tests ordered in the US i

23andMe is a privately held personal genomics and biotechnology company based in Sunnyvale, California. It is best known for providing a direct-to-consumer genetic testing service in which customers provide a saliva sample that is laboratory analysed, using single nucleotide polymorphism genotyping,[2] to generate reports relating to the customer's ancestry and genetic predispositions to health-related topics. The company's name is derived from the fact that there are 23 pairs of chromosomes in a normal human cell.[3]

The company had a previously fraught relationship with the United States Food and Drug Administration (FDA) due to its genetic health tests, but as of October 2015, DNA tests ordered in the US include a revised health component, per 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 UK since December 2014.[9]

In 2007, 23andMe became the first company to begin offering autosomal DNA testing for ancestry, which all other major companies now use. Its saliva-based direct-to-consumer genetic testing business was named "Invention of the Year" by Time magazine in 2008.[10][11][12]

The The 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.

Effective as of 25 May 2018, 23andMe must abide by the General Data Protection Regulation (GDPR).[98][99] 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.[99] The regulation also applies to companies who offer products/services outside of the EU.[99]

Medical research

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 pharmaceutical and biotechnology companies for use in their research.[5][26][100] The company also collaborates with academic and government scientists.[101][61] In July 2012, 23andMe acquired the startup CureTogether, a crowdsourced treatment ratings website with data on over 600 medical conditions.[102] 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.[88][92]

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 glucocerebrosidase as a risk factor for Parkinson's disease.glucocerebrosidase as a risk factor for Parkinson's disease.[101]

In 2015, 23andMe made a business decision to pursue drug discovery themselves, under the direction of former Genentech executive Richard Scheller.[5][103] 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 Pfizer to explore the genetic causes of inflammatory bowel disease, namely ulcerative colitis and Crohn's disease.[104][105]

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.[106] Also in 2016, 23andMe used self-reported data from customers to locate 17 genetic loci that seem to be associated with depression.[107]

In 2017, 23andMe, the Lundbeck pharmaceutical company, and the Milken Institute think tank started collaborations to focus on psychiatric disorders, such as 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.[108]

23andMe does not have a history of allowing its genetic profiles to be used by law enforcement to solve crimes, believing that it violates users' privacy.[109][110] As of February 15, 2019, 23andMe has denied data requests by law enforcement on six separate occasions.[110] However, according to section 8 of the terms of service, "23andMe is free to preserve and disclose any and all Personal Information to law enforcement agencies or others if required to do so by law or in the good faith belief that such preservation or disclosure is reasonably necessary." [111]

See also