23andme business plan

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23andMe: a new two-sided data-banking market model

Metrics details. However, on November 22, , the Food and Drug Administration FDA halted the sale of genetic health testing, on the grounds that 23andMe was not acting in accordance with federal law, by selling tests of undemonstrated reliability as predictive tests for medical risk factors. Consumers could still obtain the genetic ancestry report, but they no longer had access to the genetic health report in the United States US.

However, this did not prevent the company from continuing its health research, with previously obtained and future samples, provided that consent had been obtained from the consumers concerned, or with health reports for individuals from other countries. We describe here the profound ethical issues raised by this setup. Peer Review reports. This specialist company operates in the biotechnology sector and was founded in by Linda Avey and Anne Wojcicki.

The approach used can be summarized in five steps, as follows Fig. However, DTC health genetic testing was being carried out in the absence of a medical prescription or information from a whole-genome analysis WGA based on genome-wide association GWA studies. The use of such an approach raised questions about the reliability of the 23andMe test in terms of the rates of true and false negatives and positives as this test had not been validated as a health test , and of the information delivered to consumers.

Beyond the legal issues, we focus here on the original nature of the service provided to consumers and its probable consequences in the near future.

The interface between patients and research remains complex and potentially conflictual, due to ethical issues relating to the ownership of the body and of any data pertaining to it, which are still under debate.

In this context, a simple but innovative way of proceeding may have emerged. Given how difficult it is to obtain biological samples from a large cohort with the consent and full history of the patients in a short space of time by the standard route, the idea of creating an interface between individuals and researchers has emerged.

Indeed, information about human genomes, in addition to being a personal source of useful information for treating the sick or for healthy people that might become sick, could be exploited and used as a source of profit for companies. This vision raises profound ethical issues about the way in which subjects are included in research and about how information about them is gained and used.

An analysis of the 23andMe website and the scientific literature highlights how this and other American biotech companies have specialized in medical genetics so as to become essential intermediaries between researchers and their research subjects, through the generation of DNA banks and biobanks containing hundreds of thousands of different samples provided for DTC genetic testing. The DTC genetic testing service is the service most highlighted and best understood on the website and on social networks mostly Facebook and Twitter.

As explained above, DTC genetic testing is based on the use of SNPs to identify genetic markers associated with specific diseases and conditions and a few specific causal variants.

This test is a type of whole-genome analysis WGA carried out with a microarray, based on a technique different from whole-genome sequencing WGS or whole-exome sequencing WES , in which all the nucleotide sequences of the genome WGS or exome WES, the exome being the sum of all the exons present are determined.

The genetic information obtained by testing is made available to the consumers via their own protected personal 23andMe web accounts. This law, in its current state, protects Americans against discrimination on the basis of genetic information. The third parties are the other side to the 23andMe Research offer. Indeed, in exchange for information about their genes, the consumers supply not only money, but also web behavior information and self-reported information. All of this information is shared with or sold to third parties for the purposes of scientific research and commercial applications, patents or operating licenses.

Ethically, 23andMe seems to be at the center of a flow of information between people and research. Can 23andMe be considered to constitute a two-sided market strategy? This set-up makes possible exchanges that would not otherwise have occurred, creating value for both sides.

Both sides in this case, the people seeking DNA analyses and the structures seeking to obtain information about them can be considered to be consumers.

Two-sided markets exist in many different types of industry, occupying the same economic space as traditional offers of products or services, such as those provided by Facebook, Sony or Google Alphabet , for example. Such a market may exist in the case of 23andMe, and may, indeed, always have been planned as a business strategy. This company may effectively constitute a two-sided platform, with two kinds of consumers: people who want information about their own genes for multiple reasons , and researchers and others who want access to genetic, web behavior and self-reported information for a large number of people Fig.

Three separate events have favored this approach: growing financial investment, falling prices of genetic testing and an exponential increase in the number of consumers over a very short period of time Fig.

Biological saliva sample flows and to and from the biobank are shown in green. Decrease in kit price over time.

In the past, biological samples were stored in a single laboratory [ 8 ], but large collections of DNA samples are becoming increasingly common in human genetics. With the publication of the first draft sequence of the human genome in Nature [ 9 ] and Science [ 10 ], and its completion by the Human Genome Project, the strategic importance of DNA banking and data collection has increased.

DNA can be obtained from a number of potential sources, including the blood, cell and tissue banks of hospital and academic research centers, and it has been estimated that there are already several hundred million biological samples stored in such repositories [ 11 ].

Indeed, their collection may be one of the largest available and it is driven not only by scientific or medical aims, but also by business imperatives [ 12 ]. DNA banking is becoming a business and there is a rush to acquire DNA sequencing data, which may prove to be the organic and molecular equivalent of a gold mine. Devices for NGS first appeared in and owe their success to a synchronous sequence analysis, resulting in faster, more sensitive analyses at a lower overall cost [ 17 ].

These methods, based on a sequencing-by-synthesis approach, have increased sequence output per run and read length, and have decreased costs and improved the accuracy of base-calling [ 14 ].

This system could sequence the genomes of 18, humans per year. However, even if DNA sequencing costs are declining, questions still remain about the generation, storage, analysis and interpretation standards for genetic data.

For DNA sequencing, a DNA source is required, and interpretation of the genetic data generated requires information about the source, such as clinical data or private data for the patient. Obtaining more information about the source improves the quality of interpretation for genetic data and, thus, their scientific and medical value. However, these new approaches require even faster technology, as previously reported.

Nevertheless, this technology may, in the near future, provide real new opportunities for DTC testing services. Indeed, in medicine and industry, the key issue is the relationship between specific genetic sequences, not necessarily restricted to SNPs or potential causal mutations, and particular diseases, with a view to guiding treatment and developing new drugs.

This relationship is the key to the financial value of DNA data and may be the premise underlying the development of two-sided platforms, such as that of 23andMe, for obtaining large numbers of samples and considerable amounts of information for research and industry through a DTC genetic testing service.

These approaches are based on DNA banking, but DNA sample collections may differ considerably in several critical ways: storage, confidentiality, requests, security and quality [ 19 ]. These aspects and the differences in them between collections raise ethical issues. The two-sided market model of 23andMe can be considered a case study. This model raises important ethical questions about genetic testing, DNA banking and research relating to autonomy, ownership of the body, data obtained from the body, and informed consent Fig.

The people sending samples are not considered to be patients. They are instead considered to be consumers, and the majority are healthy. They are given the opportunity to give informed consent for participation in scientific research, but they primarily sign a commercial contract and pay for the purchase of a service, offering genetic testing. The clients give their consent alone, via their computer, at home. This set-up raises a major ethical issue: that of the autonomy of the individual, in particular, and the right to access to his or her own genetic information [ 20 ].

In France, oral information explaining the goal of testing is considered necessary. According to French civil law, the individual does not own his or her body and cannot ask directly for genetic health tests to be directly. Furthermore, it remains a matter of debate whether individuals really have the right to access their own genetic information, their own DNA [ 21 , 22 ].

A medical diagnosis must be based on the sequencing of specific genes to be considered accurate. The need to protect privacy is illustrated by the family imbalances, preventive and curative surgery following diagnosis and discrimination by insurance companies that may result from poor regulation [ 23 ].

Ethical aspects of the 23andMe model and connections with Google. Ethical issues are shown in red. Several studies have focused on genetic tests and raised the issue of the apparent ethical conflict between two concepts of autonomy: some specialists from different countries prefer to maximize autonomy, whereas others support the notion that autonomy is only effective if accompanied by protective measures [ 24 , 25 ].

Some authors have suggested that one of the prerequisites for autonomous choice is that the person is able to understand the information provided and to provide a rational argument for his or her choice [ 26 — 28 ]. The degree of autonomy of the customers of companies such as 23andMe is highly variable, depending on genetic competence [ 29 ]. Two major problems relating to autonomy are immediately apparent here: the problem of scientific literacy [ 30 ] and the lack of training of physicians in genetics [ 31 , 32 ].

Indeed, it has been shown that more than half the individuals buying genetic tests online subsequently consult a physician to discuss the result [ 33 ]. Such a service would ensure that physicians were better trained in the interpretation and explanation of genetic tests and would ensure better counseling and follow-up for users, while providing users with greater autonomy. It would also make it possible for the test offered by 23andMe to be considered a real medical diagnosis test rather than as simply providing information.

This vision of autonomy differs from those prevailing in the UK and the US, in which all individuals wishing to have access to their genetic and medical data are free to do so, provided an agreement has been reached with the family in cases of clinical analysis, regardless of their level of genetic knowledge and the conditions of the service on offer [ 29 , 34 ].

For preventive surgery, the best known case is undoubtedly that of an American actress who underwent a prophylactic double mastectomy following positive results in a genetic test for the breast cancer 1 BRCA1 mutation [ 37 ].

In the wake of her decision, an increase was observed in the numbers of BRCA1 and 2 tests and of prophylactic double mastectomies carried out [ 38 ]. Over and above the principle of not doing harm, which is called into question by major, potentially traumatic surgery, this approach also raises questions about the principle of autonomy, because there may be a risk of abuse in the long term. Indeed, if such practices were to become systematic, insurers might have the right to oblige their clients to undergo testing if they have a family history of disease, particularly for genetic predispositions to cancer, due to the costly and debilitating nature of targeted treatments if the disease is diagnosed late.

Ethical issues also arise within the testing company. These issues include the dematerialization and digitization of data, the anonymization of genetic data, the confidentiality of self-reported information and the storage of data and samples Fig. Indeed, when informed consent forms and the commercial contract are signed digitally, the consumers provide the company with their names, together with a set of personal information about themselves and their families relating to health and ethnicity.

The company states on its website that names, addresses, e-mail addresses and bank data will not be disclosed or used. Nevertheless, such information Fig. It is therefore unsurprising that the contract stipulates that data, DNA and biological samples will be kept and may be re-used in other research if the consumer consents. With the multiplication of this transaction by hundreds of thousands of individuals, the company is well aware that its consumers have not only paid a few hundred dollars each, on average, for genetic testing services, but have actually sold their samples and information for inclusion in a major biobank and database for use by scientists and doctors.

But what are the consequences for the consumer? Can separate pieces of information about an individual be brought together? These issues have not been sufficiently explored by the company, which seems to safeguard its own interests more strongly than those of its consumers, although 23andMe received institutional review board approval for its research protocol and a revised consent document in 23andMe blog.

A client may therefore unknowingly carry a deleterious mutation that may be reported in the information delivered by the company or may knowingly carry such a mutation that is not identified in the results delivered by the company. The risk of false-positive or false-negative results for these tests is the principal concern of the FDA and its approval process [ 42 ]. However, in the context of a study of several thousand people carried out by GWA , missing a single SNP in an individual is not a problem because there are thousands of others.

At an individual level, missing a SNP may have much greater consequences. The previous economic model was based on low prices to attract more consumers, providing more data and biological samples to be valorized and sold.

The four rounds of investment in this company Fig. This second market has now been established through the collaboration between 23andMe and Genentech. In the United States, genetic tests for medical purposes are accessible without a medical prescription and are billed by the laboratories concerned. However, 24 American states have prohibited divulgation of the results of genetic tests in the absence of a physician. Nevertheless, companies selling genetic tests via the Internet, such as 23andMe, at least before they were prevented from doing so by the FDA, report the results of their tests directly to their clients.

Instead, it is seen as ordinary personal information, unless supplied by a genetic test governed by the FDA.

(Neither should GSK's $ million investment in the company). in the service of science has been 23andMe's business plan all along. 23andMe's Business Model. CEO Anne Wojcicki said the company's vision was, “​to help people access and learn from their genetic data, get the general public.

The company was established with the goal of giving consumers the ability to order genetic tests and receive results. The name is a reference to the fact that human DNA is arranged into 23 pairs of chromosomes. The service launched in the U.

Metrics details. However, on November 22, , the Food and Drug Administration FDA halted the sale of genetic health testing, on the grounds that 23andMe was not acting in accordance with federal law, by selling tests of undemonstrated reliability as predictive tests for medical risk factors.

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[23andMe Valuation] – 23andMe Business Model & How it makes Money

That's helped consumer genetics companies like Ancestry and 23andMe grow to massive scales — with more than 15 million and 10 million users respectively who've shipped off their spit with the hopes of learning more about their family trees, genetic traits, or even some health information. Still, for years, it seemed like interest in genetic testing was only increasing. But this year, the companies are starting to run into a slowdown. The first warning was raised by Illumina, the genetics giant that makes all the tech these companies uses to read info about your genes. On an earnings call in July , the company noted "softness" in the market.

23andMe: Evolution of a genomics company

I have been lately too much involved in HealthCare startups, because I have a feeling that health is gonna be at the top of the priority list for every one, and this is one thing that people spend on without blinking an eye! At one side of the equation is Con StartUps like Theranos who duped investors of their money for something that did not exist and at the other side are some tech startups that call themselves as HealthCare startups but are Vanilla Software startups like Practo — 23andMe is actually between both! The reason I say that is because they started with Genetic Code Mapping Ancestry Testing for Individual customers like you and me but when they realized this is just a one time fun thing for many and they may not be able to pull off another Con story like Theranos they pivoted into a full blow research and services company along with drug discovery pipeline focusing on developing health tests like Theranos! It was founded in They then mine this big data for research related to medical drug discovery or other pharmaceutical applications. But these OTC kits were not really OTC, you had to send back the sample to them so that they can test it out and send you back the reports, this is how they collected data. Though they had plans of using this data later on, but they just recently started the research based practice. They today boast of having more than 2 million customers across gender, race and age the largest on the planet. What I think of their D2C business model is that it is a complete waste of investor money in the short run for the next 5 years or more, give or take 2 years and then they will just blast off creating immense value for the investors in the long run by actually making sense to a large technology company like Google or Tesla, either of which will eventually integrate this large pool of personal genetic code of billions of people into a chat bot which would then replace basic medicine practitioners.

As millions of Americans sat down to Thanksgiving dinner, the biomedical researcher James Hazel sent out a stark warning about the genetic-testing kits that he surmised would be a hot topic of conversation. Hazel reached this conclusion after reviewing the privacy policies and terms of service of nearly genetic-testing companies that offer their services directly to people.

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 , [1] to generate reports relating to the customer's ancestry and genetic predispositions to health-related topics. The company is named for the 23 pairs of chromosomes in a normal human cell.

Many of us would be delighted to contribute to medical advances. Earlier this year, 23andMe announced the first two of a number of deals with pharmaceutical and biotech corporations, including some of the largest in those sectors. And while a law prohibits health insurance companies and employers from discrimination based on genetic information, the law does not cover disability, life or long-term care Last night, I entered intimate personal health information into a database that can be accessed by anyone. This is not a decision that I made lightly. The genome was similar to that of the coronavirus that caused the SARS outbreak, yet it also had striking When Lisa DeAngelico found out she had Stage 4 breast cancer two years ago at age 47, she says one of the hardest parts about her diagnosis was telling her mother. Main navigation. Search Search Donate. Perspectives Movie Review: Human Nature. By Pete Shanks By CGS Staff Assisted Reproduction. Related Articles. Does it matter that traces of coronavirus have been found in semen?

Remember Me. As of October , 23andMe has yet to turn a profit [3]. However, the consumer is only one of the stakeholders to which 23andMe delivers value. Large pharmaceutical companies and biotechs have taken note. By leveraging its core asset—a robust genomic database supplemented by user-provided lifestyle information—23andMe has expanded its business model beyond the consumer and captured additional value generated through its operations. The power of partnerships.