Marketing Of Genetic Tests Research Articles

Trading In Our Lederhosen for Kilts

The popularity of direct-to-consumer genetic ancestry services has exploded over the past five years, with as many as 250 direct-to-consumer genetic ancestry testing companies currently operating and estimates that 1 in 5 Americans are customers of one or more of those companies. Marketing of genetic ancestry testing has consistently linked the results of DNA testing to a consumer’s racial and ethnic identity, and, because of that, can help consumers find out “who they really are.” We argue that the “biologization” of race and ethnicity promoted in such marketing violates norms of marketing ethics. In particular, we show that this marketing technique violates a number of the core commitments and values of the American Marketing Association Statement of Ethics.

Strange Affinities in the Search for Personalized Health: New Age Practices and Genetic Testing

AbstractA prominent focus of New Age beliefs and practices has always been health and healing—including the use of holistic healing, power crystals, homeopathy, and complementary and alternative medicine. Given its association with modern science and medicine, genetic testing would seem to run counter to New Age alternative medical practices. On the other hand, the use of at‐home genetic health tests and the use of such New Age alternative medical practices could both be motivated by a desire for personalized healthcare. Using data generated from a survey fielded on a probability sample of U.S. adults, we examine associations between individuals’ use of at‐home genetic health tests and their use of power crystals and acupuncture or other homeopathic medicine. Logistic regression models find that those who use power crystals or homeopathic medicine have significantly greater odds of having used an at‐home genetic health test. We discuss the implications of these findings for our understanding of the direct‐to‐consumer genetic testing market and the relationship between science, religion, and spirituality more broadly.

GRAPE: genomic relatedness detection pipeline.

Classifying the degree of relatedness between pairs of individuals has both scientific and commercial applications. As an example, genome-wide association studies (GWAS) may suffer from high rates of false positive results due to unrecognized population structure. This problem becomes especially relevant with recent increases in large-cohort studies. Accurate relationship classification is also required for genetic linkage analysis to identify disease-associated loci. Additionally, DNA relatives matching service is one of the leading drivers for the direct-to-consumer genetic testing market. Despite the availability of scientific and research information on the methods for determining kinship and the accessibility of relevant tools, the assembly of the pipeline, which stably operates on a real-world genotypic data, requires significant research and development resources. Currently, there is no open source end-to-end solution for relatedness detection in genomic data, that is fast, reliable and accurate for both close and distant degrees of kinship, combines all the necessary processing steps to work on a real data, and is ready for production integration. To address this, we developed GRAPE: Genomic RelAtedness detection PipelinE. It combines data preprocessing, identity-by-descent (IBD) segments detection, and accurate relationship estimation. The project uses software development best practices, as well as Global Alliance for Genomics and Health (GA4GH) standards and tools. Pipeline efficiency is demonstrated on both simulated and real-world datasets. GRAPE is available from: https://github.com/genxnetwork/grape.

Perceived fairness of direct-to-consumer genetic testing business models

Although consumers and experts often express concerns regarding the questionable business practices of direct-to-consumer (DTC) genetic testing services (e.g., reselling of consumers’ genetic data), the DTC genetic testing market keeps expanding rapidly. We employ retail fairness as our theoretical lens to address this seeming paradox and conduct a discrete choice experiment with 16 attributes to better understand consumers’ fairness perceptions of DTC genetic testing business models. Our results suggest that, while consumers perceive privacy-preserving DTC genetic testing services fairer, price is the main driver for fairness perception. We contribute to research on consumer perceptions of DTC genetic testing by investigating consumer preferences of DTC genetic testing business models and respective attributes. Further, this research contributes to knowledge about disruptive business models in healthcare and retail fairness by contextualizing the concept of retail fairness in the DTC genetic testing market. We also demonstrate how to utilize discrete choice experiments to elicit perceived fairness.

GRAPE: genomic relatedness detection pipeline

Classifying the degree of relatedness between pairs of individuals has both scientific and commercial applications. As an example, genome-wide association studies (GWAS) may suffer from high rates of false positive results due to unrecognized population structure. This problem becomes especially relevant with recent increases in large-cohort studies. Accurate relationship classification is also required for genetic linkage analysis to identify disease-associated loci. Additionally, DNA relatives matching service is one of the leading drivers for the direct-to-consumer genetic testing market. Despite the availability of scientific and research information on the methods for determining kinship and the accessibility of relevant tools, the assembly of the pipeline, that stably operates on a real-world genotypic data, requires significant research and development resources. Currently, there is no open source end-to-end solution for relatedness detection in genomic data, that is fast, reliable and accurate for both close and distant degrees of kinship, combines all the necessary processing steps to work on real data, and is ready for production integration. To address this, we developed GRAPE: Genomic RelAtedness detection PipelinE. It combines data preprocessing, identity-by-descent (IBD) segments detection, and accurate relationship estimation. The project uses software development best practices, as well as Global Alliance for Genomics and Health (GA4GH) standards and tools. Pipeline efficiency is demonstrated on both simulated and real-world datasets. GRAPE is available from: https://github.com/genxnetwork/grape.

Genomics update 2022: Clinician and patient hot topics.

Advances in genomics research and clinical applications continue to accelerate. Coupled with the availability of direct-to-consumer (DTC) marketing of genetic testing and new discoveries, patients are increasingly coming into primary care with genomic questions. This article offers a snapshot of the kinds of questions patients are asking and that providers should be prepared to discuss such as what to do with DTC results or whether pharmacogenetics testing would help make sure "the right" medication is prescribed. Clinicians should understand the value of clinical guidelines (and where to find them), how to find a genetic specialist, what's happening with gene editing (to include gene sequencing), what's on the horizon in cancer care, and what the future might hold.

Knowledge and Attitudes about Privacy and Secondary Data Use among African-Americans Using Direct-to-Consumer Genetic Testing

Introduction: The rapidly expanding direct-to-consumer genetic testing (DTC GT) market is one area where narratives of underrepresented populations have not been explored extensively. This study describes African-American consumers’ personal experiences with and perceptions about DTC GT and explores similarities and differences between African-Americans and an earlier cohort of mostly European American consumers. Methods: Twenty semi-structured, qualitative interviews were held with individuals who self-identified as Black/African-American and completed DTC GT between February 2017 and February 2020. Interviews were transcribed and consensus-coded, using inductive content analysis. Results: Participants generally had positive regard for DTC GT. When considering secondary uses of their results or samples, most participants were aware this was a possibility but had little concrete knowledge about company practices. When prompted about potential uses, participants were generally comfortable with research uses but had mixed outlooks on other nonresearch uses such as law enforcement, cloning, and product development. Most participants expressed that consent should be required for any secondary use, with the option to opt out. The most common suggestion for companies was to improve transparency. Compared to European American participants, African-American participants expressed more trust in DTC GT companies compared to healthcare providers, more concerns about law enforcement uses of data, and a stronger expression of community considerations. Discussion/Conclusion: This study found that African-American consumers of DTC GT had a positive outlook about genetic testing and were open to research and some nonresearch uses, provided that they were able to give informed consent. Participants in this study had little knowledge of company practices regarding secondary uses. Compared to an earlier cohort of European American participants, African-American participants expressed more concerns about medical and law enforcement communities’ use of data and more reference to community engagement.

DTC genetic test for customized cosmetics in COVID-19 pandemic: Focused on women in their 40s and 60s in Seoul, Republic of Korea.

BackgroundSevere acute respiratory syndrome coronavirus disease 19 (COVID‐19) is attracting worldwide attention and has been declared an infectious disease by the World Health Organization (WHO), and accordingly, interest and meaning in health and well‐being are expanding in recent years.AimsThis paper attempted to investigate the recognition and development potential of customized cosmetics focusing on inner beauty products through DTC (Direct to Customer) genetic testing in the era of COVID‐19 pandemic.Patients/MethodsThe number of women included in the survey of consumers living in Seoul metropolitan city ranged from 40 to 60, and 380 women in Republic of Korea. Statistical processing of the data collected by the data analysis method is analyzed using the Statistical Package for Social Science (SPSS) WIN25.0 statistical package program through the process of data coding and data cleansing.ResultsIn this study, the DTC genetic test, single, and/or combination treatment for customized inner beauty products and customized cosmetics were compared and analyzed, respectively. Accordingly, in keeping with the rapidly changing market conditions, we sought to study customized inner beauty and customized cosmetics recognition and purchasing behavior through DTC genetic testing in the unexplored era after COVID‐19 pandemic. As a result, it was significantly more effective to use customized inner beauty and customized cosmetics after DTC genetic test (p < 0.001).ConclusionThis study emphasizes that after the global COVID‐19 pandemic worldwide that occurred after January 2020, the definition of health persistence, wellness, and well‐dying associated with beauty and cosmetology is also evolving from the DTC genetic test. In our results, it was found for the first time that the intake of customized inner beauty preparations and the use of customized cosmetics would be more effective. In the above significant research results, it is believed that research on the combinational effect of customized inner beauty products and customized cosmetics is required in the global DTC genetic testing market.

Sales, Acquisitions, and Mergers of Direct-to-Consumer Genetic Testing Companies

Direct-to-consumer genetic tests have become increasingly popular in the United States within the last few years. However, these tests pose many risks to the consumer, most notably privacy risks. A subset of these privacy risks involves the issue of company mergers, acquisitions, and sales. Many companies in the direct-to-consumer genetic testing market have privacy policies that contain a variation of a “business transfer” clause. These clauses specify that in the event the company goes through a business transition such as a sale, merger, or acquisition, the consumer’s personal information—including the consumer’s DNA—will be among the assets transferred. This Article explores the risks associated with these business transfer clauses as they relate to the consumer, and presents a solution to mitigate said risks. The solution lies in FTC v. Toysmart, wherein a toy company that filed for bankruptcy was restricted in selling its assets—which included its customers’ personal data— only to entities with the same interests as the toy company. This Article urges that the default interpretation standard of business transfer clauses track similarly such that a direct-to-consumer genetic testing company may only be sold to, merged with, or acquired by a company with the same or like interests.

Genetic Variant Reinterpretation: Economic and Population Health Management Challenges.

Genetic Variant Reinterpretation: Economic and Population Health Management Challenges.

Direct-to-consumer genetic testing: a regulation by the market, or a medical regulation?

The direct-to-consumer genetic testing (DTC-GT) market has been developing for about twenty years now, raising various debates, even controversies. But what about the regulation of these so-called "innovative" devices, but whose medical status is ambiguous? A first regulatory aspect is depending on the market itself, since the latter is currently subjected to a strong structuring process. A second regulatory aspect, more classical, is the legal one. While the DTC-GT status has long been unclear on European scale, a new text (a Regulation, not a Directive) is modifying the situation. It encourages regulation "by the market" rather than "by the medical profession", which does not imply that the latter will have no (indirect) impact on the DTC-GT market.

Valuable Genomes: Taxonomy and Archetypes of Business Models in Direct-to-Consumer Genetic Testing.

BackgroundRecent progress in genome data collection and analysis technologies has led to a surge of direct-to-consumer (DTC) genetic testing services. Owing to the clinical value and sensitivity of genomic data, as well as uncertainty and hearsay surrounding business practices of DTC genetic testing service providers, DTC genetic testing has faced significant criticism by researchers and practitioners. Research in this area has centered on ethical and legal implications of providing genetic tests directly to consumers, but we still lack a more profound understanding of how businesses in the DTC genetic testing markets work and provide value to different stakeholders.ObjectiveThe aim of this study was to address the lack of knowledge concerning business models of DTC genetic testing services by systematically identifying the salient properties of various DTC genetic testing service business models as well as discerning dominant business models in the market.MethodsWe employed a 3-phased research approach. In phase 1, we set up a database of 277 DTC genetic testing services. In phase 2, we drew on these data as well as conceptual models of DTC genetic testing services and iteratively developed a taxonomy of DTC genetic testing service business models. In phase 3, we used a 2-stage clustering method to cluster the 277 services that we identified during phase 1 and derived 6 dominant archetypes of DTC genetic testing service business models.ResultsThe contributions of this research are 2-fold. First, we provided a first of its kind, systematically developed taxonomy of DTC genetic testing service business models consisting of 15 dimensions in 4 categories. Each dimension comprises 2 to 5 characteristics and captures relevant aspects of DTC genetic testing service business models. Second, we derived 6 archetypes of DTC genetic testing service business models named as follows: (1) low-cost DTC genomics for enthusiasts, (2) high-privacy DTC genomics for enthusiasts, (3) specific information tests, (4) simple health tests, (5) basic low-value DTC genomics, and (6) comprehensive tests and low data processing.ConclusionsOur analysis paints a much more complex business landscape in the DTC genetic testing market than previously anticipated. This calls for further research on business models and their effects that underlie DTC genetic testing services and invites specific regulatory interventions to protect consumers and level the playing field.

Study on the differences of opinions and choices of high-risk breast cancer populations in China before and after genetic testing.

BackgroundIn recent years, genetic testing (GT) has developed rapidly in China. However, the cancer genetic service system is still immature in China. Little is known about the opinions around genetic counseling (GC) and GT in Chinese individuals at high risk of breast cancer. This work aims to understand the changes in awareness, attitudes, and willingness of high-risk populations before and after GT, as well as the possible barriers to GC/GT.MethodsSeveral questionnaires for the high-risk populations of breast cancer were completed. Then, some patients were selected for free single/multi-gene testing as well as further survey and statistical analysis.ResultsDespite low levels of awareness, Chinese high-risk breast cancer groups hold positive attitudes about GC/GT. There were differences in the willingness of different groups of high-risk people. After GT, different testing results led to different views and choices for the patients than before GT. Lack of genetic knowledge of breast cancer, misunderstanding, cost, fear of adverse effects, and policy market factors are obstacles to accepting GC/GT for the participants.ConclusionsChinese doctors need to communicate according to the specific situation of high-risk individuals in pre-test counseling and post-test counseling. The national policy and GT market also need to be improved to support the hereditary breast cancer families’ follow-up service system.

5 Years of Steady Progress: DTC Genetic Testing Service MYCODE

Abstract In the United States, companies like 23andme and Ancestry.com have driven the establishment and growth of the direct-to-consumer (DTC) genetic testing market. However, in Japan the DTC genetic testing market is only just getting off the ground. In 2014, DeNA Life Science launched the DTC genetic testing service MYCODE, which predicts disease risk associated with SNPs, based on collaborative research with The Institute of Medical Science at the University of Tokyo. MYCODE leads the industry with its high level of service quality, emphasizing test quality, scientific evidence, providing information to consumers, security, and due consideration to ethics. The social significance of MYCODE is not only the opportunity to inspire consumers to form healthier behavioral habits, but also that this service worked to create a DTC genetic testing market. There is also a mechanism in place for individuals in the MYCODE community to participate voluntarily in research (Community-Derived Science). Going forward, through MYCODE we hope to contribute to the healthy spread and growth of the DTC genetic testing market in Japan.

Genetic Data Privacy Solutions in the GDPR

The intersection of healthcare and technology is a rapidly growing area. One thriving field at this intersection involves obtaining, processing, and storing genetic data. While the benefits have been great, genetic information can reveal a great deal about individuals and their families. And the information that can be conveyed from genetic data appears limitless and is constantly growing and changing. Many entities have begun storing, processing, and sharing genetic data on a very large scale. This creates many privacy concerns that the current regulatory framework does not account for. The line between patient data and consumer data is blurred; many entities are interested in obtaining genetic data with varied interests. In the direct-to-consumer genetic testing market, consumers pay to send private companies their DNA samples in exchange for a trivial amount of information about their ancestry and health risks. But health data obtained and processed by a company are subjected to far less stringent privacy regulations than health data obtained and processed at a doctor’s office or hospital. This Comment summarizes some of the current genetic privacy problems in United States laws and examines the EU’s recently adopted GDPR for a possible solution. A GDPR-style regulation could provide more consistency, give individuals more control, and protect against future unknown uses.

Is health-care data the new blood?

Is health-care data the new blood?

Direct to Consumer Fitness DNA Testing.

The direct to consumer (DTC)2 genetic testing market was initiated in 2007 with the introduction of 23andMe. Since then, there has been marked expansion and, at the same time, considerable efforts to scrutinize the potential benefits and harms of such testing (1). The various tests are heterogeneous, with output ranging from medical data to ancestry to lifestyle. Along the way, fitness-centered DTC genetic tests have cropped up, encouraging consumers to pay, as we will briefly describe here, high costs for what we feel to be low value information. These tests promise insights about nutrition, healthy aging, weight loss, and athletic aptitude (even for specific sports). They market faux scientific authority, engendering confusion and the potential for harm, no less diminishing consumer confidence in validated, actionable, genetic tests. The genetic testing market is currently divided into 2 main categories with a couple of exceptions that operate in both arenas. Clinical tests require that a physician order each test, are subject to regulatory oversight, and are aimed at diagnosing or screening for mutations related to specific medical conditions. In contrast, DTC tests are purchased without any need for physician involvement. Current surveys identify approximately 40 companies offering DTC fitness genetic tests (2) and several companies that serve as a marketplace for purchasing a variety of such tests interpreted by third parties. Although registries exist to provide some assistance for medical genetics professionals to choose between the approximately 75000 clinical genetic tests available (3), there is no such resource for consumers. DTC genetic test prices range from under $30 to well over $1000. The less expensive tests are generally for individual single nucleotide variants, and marketing by some DTC companies drives sales of multiple tests per customer. The DTC genetic testing market is estimated to total about $100 million in 2017, with …

Direct-to-Consumer Genetic Testing: Finding a Clear Path Forward.

Regulatory compliance in the direct-to-consumer genetic testing market is highly sophisticated as there are numerous federal, state, and ethical barriers to entry. In 2010, amid an underregulated market, 23andMe sought to do what few companies in the medical industry had attempted before-disregard the guidance and requests of the US Food and Drug Administration. This regulatory strategy effectively destined the company's Personal Genome Service for failure; however, the company changed course and has been granted several regulatory clearances. This exemplifies the importance of a healthy relationship with regulatory agencies, although challenges remain. The DTC industry continues to have a perplexing regulatory framework at both the federal and state level. There are also ethical concerns with the monetization of deidentified genetic health information, as genetic data have an inherent level of identifiability and are not fully protected by the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule in these scenarios. Although some DTC tests are now cleared in the United States, the concern that a learned intermediary is needed for interpretation of results remains. The regulatory oversight of this market will need to continue to develop to ensure the protection of consumer health and privacy.

Patients Armed With Their Own Genetic Data Raise Tough Questions.

With the market for direct-to-consumer genetic testing expanding rapidly, clinicians are playing catch-up.

Potential Benefits and Drawbacks to Direct-to-Consumer Genetic Testing

With the advent of the genomic age we are now able to sequence individual genomes and determine the likelihood of developing a disease state. Due to the lower cost of sequencing DNA at a large scale there has been a plethora of DNA kits for the consumer market. This opens opportunities for direct contact to the consumer about their individual ancestry and potential diseases. These opportunities on the surface seem useful for the consumer, but we must consider the validity of the pathological or non-pathological claims. This direct-to-consumer genetic testing market might need to have better regulatory oversight to maintain validity and quality of the genetic claims. In addition to collecting DNA information on individuals, it is possible to correlate genetic linkage maps on larger population sets to see patterns of disease and potential therapies. With any personal information security is of the upmost importance, especially with individual DNA sequences.