23andme
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23andme

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.[3]

The company had a previously fraught relationship with the U.S. Food and Drug Administration 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 United Kingdom 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]

History

The company was founded by Linda Avey, Paul Cusenza and Anne Wojcicki in 2006 to provide genetic testing and interpretation to individual consumers.[13][14] In 2007, Google invested $3,900,000 in the company, along with Genentech, New Enterprise Associates, and Mohr Davidow Ventures.[15] Wojcicki was married to Google co-founder Sergey Brin at the time.[7]

Cusenza left the company in 2007 and was appointed CEO of Nodal Exchange in 2008.[16] Avey left the company in 2009 and co-founded Curious, Inc. in 2011.[17]

In 2012, 23andMe raised $50 million in a Series D venture round, almost doubling its existing capital of $52.6 million.[18][19][20] In 2015, 23andMe raised $115 million in a Series E offering, increasing its total capital to $241 million.[5][21][22]

In June 2017, 23andMe created a brand marketing advertisement featuring Gru from the movie Despicable Me.[23] In 2018, the company further marketed its brand in advertisements narrated by Warren Buffett.[24]

In September 2017, the company was rumored to be raising another $200M in venture funding with a valuation of $1.5 billion, as of that the time (prior to the raise) the company had raised $230 million since it was founded.[25] Afterwards, it was reported that the company raised $250M at a valuation $1.75B.[26]

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.[10][27] 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.[28][29][30]

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.[10][31][32] By August 2008, 23andMe had received licenses that allow them to continue to do business in California.[33]

FDA

According to Anne Wojcicki, 23andMe had been in dialogue with the FDA since 2008.[30] 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.[28][34][35] 23andMe first submitted applications for FDA clearance in July and September 2012.[36]

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.[37]

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".[36][38][39] As of December 2, 2013, 23andMe had stopped all advertisements for its PGS test but is still selling the product.[40][41] As of December 5, 2013, 23andMe was selling only raw genetic data and ancestry-related results.[4][42][43]

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."[44][45][46] 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."[30]

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][42][43]

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.[47] 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.[48][49] 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.[48][50] The FDA sent further clarification about regulation of the test to 23andMe on October 1, 2015.[51]

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.[52]

23andMe submitted a "de novo" application 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.[53][54] 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.[53]

In March 2018, the FDA approved another de novo application from the company, this one for a DTC test for three specific BRCA mutations that are the most common BRCA mutations in people of Ashkenazi descent; they are not the most common BRCA mutations in the general population, and the test is only for three of the approximately 1,000 known mutations. These mutations increase the risk of breast and ovarian cancer in women, and the risk of breast and prostate cancer in men.[55]

Products and services

Direct to consumer genetic testing

Test kit by 23andMe

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.[13][56][57] 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.[10]

After the sample is received by the lab, the DNA is extracted from the saliva and amplified so that there is enough to be genotyped. The DNA is then cut into small pieces, and applied to a glass microarray chip, which has many microscopic beads applied to its surface. Each bead has a probe on it that matches the DNA of one of the many variants the company test for. If the sample has a match in the microarray, the sequences will hybridize, or bind together, letting researchers know that this variant is present in the customer's genome by a fluorescent label located on the probes. Tens of thousands of variants are tested out of the 10 to 30 million located in the entire genome. These matches are then compiled into a report that is supplied to the customer, allowing them to know if the variants associated with certain diseases, such as Parkinson's, Celiac's and Alzheimer's, are present in their own genome.[58]

Uninterpreted raw genetic data may be downloaded by customers.[27] This provides customers with the ability to chose one of the 23 chromosomes, as well as mitochondrial DNA, and see which base is located in certain positions in genes, and see how these compare to other common variants. 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 can also view their mitochondrial haplogroup (maternal) and Y chromosome (paternal) haplogroup only if they are male or a relative shared a patriline has also been tested. 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][59][60] 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][42][43] 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.[61][62] FDA marketing restrictions reduced customer growth rates[63] but by 2018 they had tested five million individuals.[1][64]

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.[65] This decision was reversed a year later when the different products were recombined.[28] In late 2010 the company introduced a monthly subscription fee for updates based on new medical research findings.[28][66] The subscription model proved unpopular with customers and was eliminated in mid-2012.[67]

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][42][43] when it announced that it would resume providing health information in the form of carrier status and wellness reports with FDA approval.[68] 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 $399 in 2008[69] and to $99 in 2012,[18] and was effectively being sold as a loss leader in order to build a valuable customer database.[27][70][71] In October 2015, the US price was raised to $199.[68] 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.[72]

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.[73]

In February 2018, 23andMe announced that its ancestry reporting would tell people what country they were from, not just what region, and increased the number of regions by 120. Like other companies, it still lacked data about Asia and Africa, which the African Genetics Program (launched in October 2016 with a grant from the US National Institutes of Health) will rectify by recruiting sub-Saharan Africans to increase the genomic data on racial and ethnic minorities.[74][75] Building off of the African Genetics Program, the Global Genetics Program was also announced in February 2018. This program aims to increase the genomic data of 61 underrepresented countries in their database by providing free tests to individuals that have all 4 grandparents from one of the countries. In April 2018, 23andMe announced the Populations Collaboration Program, which sets up formal collaborations between the company and researchers that are investigating underrepresented countries.[76]

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.[77][78]

Accuracy concerns

Customers comparing 23andMe results to other genomic and ancestry testing companies have received highly differing results, possibly due to human error, or the analysis of the DNA extraction due to overrepresentation of one country/region over another in the database.[79] Ancestry results are based on the amount of confidence the company has that the DNA is from a specific region, leading to both specific countries when the confidence is high, and broad regions when the confidence is low. This can lead to surprising results due to specific countries getting masked by low confidence in the DNA.[80] The possibility of false positives also adds to customer confusion and unnecessary concerns when interpreting results.[81]

Informed consent and privacy concerns

Questions have been raised since at least 2013 as to whether the company can obtain informed consent through its web-based interactions with people who want to submit samples for sequencing.[82][83]

The company collects not only genetic information from people who order DNA tests and personal information that such customers actively disclose on the 23andme website, but also data about other behavior that 23andMe captures through the use of cookies and through its smartphone app. Many companies from pharmaceutical companies to insurance companies as well as law enforcement have an interest in such datasets.[84] People may not actually be aware of how the company uses the data, and there are always risks of data breaches.[85]

Medical research

Aggregated customer data is studied by scientific researchers employed by 23andMe for research on inherited disorders; rights to use customers's data is also sold to pharmaceutical and biotechnology companies for use in their research.[5][27][86] The company also collaborates with academic and government scientists.[87][63] In July 2012, 23andMe acquired the startup CureTogether, a crowdsourced treatment ratings website with data on over 600 medical conditions.[88] In 2010, 23andMe said that it was able use its database to validate work published by the NIH identifying mutations in glucocerebrosidase as a risk factor for Parkinson's disease.[87]

In 2015, 23andMe made a business decision to pursue drug discovery themselves, under the direction of former Genentech executive Richard Scheller.[5][89] 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 colitis and Crohn's disease.[90][91]

In 2016, a project the company was developing that would 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 directly to consumers, both quickly and precisely, according to CEO Anne Wojcicki.[92] Also in 2016, 23andMe used self-reported data from customers to locate 17 genetic locations that seem to be associated with depression.[93]

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 depression. Their goals are to determine the genetic roots of such disorders, as well as pursue drug discovery in those areas.[94]

See also

References

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Further reading

External links


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