Article
Business
Philipp A. Toussaint, Scott Thiebes, Manuel Schmidt-Kraepelin, Ali Sunyaev
Summary: This study examines consumers' fairness perceptions of direct-to-consumer genetic testing business models using the theoretical lens of retail fairness. The findings suggest that price is the main driver of fairness perception, although consumers also perceive privacy-preserving genetic testing services as fairer.
ELECTRONIC MARKETS
(2022)
Review
Medicine, Research & Experimental
Mary A. Majumder, Christi J. Guerrini, Amy L. McGuire
Summary: This review discusses the trends in direct-to-consumer genetic testing, including quality, psychosocial impact, integration with medical practice, effects on the healthcare system, privacy issues, and third-party interpretation services and non-health-related uses. It presents two possible futures for DTC genetic testing: merger with traditional healthcare delivery or continuation as an independent system.
ANNUAL REVIEW OF MEDICINE, VOL 72, 2021
(2021)
Review
Health Care Sciences & Services
Jin K. K. Park, Christine Y. Y. Lu
Summary: This article discusses the ethical, legal, and social implications of using polygenic scores (PGS) in direct-to-consumer (DTC) genetic tests, and synthesizes existing solutions to these concerns. The concerns mainly involve industry variation, privacy and commercialization, patient safety and risk.
JOURNAL OF PERSONALIZED MEDICINE
(2023)
Article
Business
Alexander Nill, Gene Laczniak
Summary: This paper provides an analysis of marketing ethics in the direct-to-consumer (DTC) selling of genetic tests (GT). It explores the ethical and social questions raised by this emerging sector and suggests possible policy adjustments. The paper calls for a public discourse to define the ethical guidelines and systemic adjustments necessary for fairness in DTC transactions between sellers and buyers/clients of genetic test services.
JOURNAL OF BUSINESS ETHICS
(2022)
Editorial Material
Ethics
Kyle van Oosterum
Summary: The response points out the potential harm to genetic privacy and discusses the need to balance it against the autonomy-related gains of DTC genomic services. By drawing on conceptual connections between privacy and autonomy, the response shows how DTC genetic testing can limit valuable options and impact individuals' exercise of autonomy.
JOURNAL OF MEDICAL ETHICS
(2022)
Article
Genetics & Heredity
Tessa Marzulla, J. Scott Roberts, Raymond DeVries, Diane R. Koeller, Robert C. Green, Wendy R. Uhlmann
Summary: This study interviewed individuals who sought genetic counseling after DTC GT results to explore their motivations, expectations, and experiences. Motivations for seeking genetic counseling included family and personal health histories, concern and confusion about results, and information-seeking. Participants generally viewed DTC GT results as valid and impactful for healthcare, and had high expectations for the counseling sessions. Key elements identified for a successful DTC GT genetic counseling session included effective contracting, managing expectations, explaining the differences between DTC GT and clinical genetic testing, and listening to patient concerns.
JOURNAL OF GENETIC COUNSELING
(2021)
Article
Genetics & Heredity
Vicky Hsieh, Tamara Braid, Erynn Gordon, Laura Hercher
Summary: Findings from the study indicate that while most respondents would be more accepting of DTC-GT if genetic counseling was incorporated into the process, the majority of genetic counselors do not feel comfortable providing this service.
JOURNAL OF GENETIC COUNSELING
(2021)
Review
Biotechnology & Applied Microbiology
Madej Malgorzata, Sasiadek Maria, Witt Michal
Summary: Direct-to-consumer tests offer individuals the opportunity to access genetic information freely without medical supervision, but they also carry the risk of false results and potential negative health and psychological consequences. European countries and organizations have implemented legal frameworks to regulate the DTC market, focusing on principles such as patient protection, informed consent, and medical information confidentiality.
JOURNAL OF APPLIED GENETICS
(2022)
Article
Ethics
Jordan A. Parsons, Philip E. Baker
Summary: This article discusses the ethical issues in genetic testing and argues for a shift in responsibility from the proband to the provider. It proposes that providers should have a duty to share results with relatives in the event of actionable risks. Privacy concerns are addressed through a pre-emptive consent model that balances the rights of relatives and the privacy of the proband.
JOURNAL OF MEDICAL ETHICS
(2022)
Article
Genetics & Heredity
Janessa Mladucky, Bonnie Baty, Jeffrey Botkin, Rebecca Anderson
Summary: In direct-to-consumer genetic testing, customers have some understanding of the secondary uses of data, but when previously unconsidered uses of data were discussed, some customers expressed concerns about privacy protections.
PUBLIC HEALTH GENOMICS
(2021)
Article
Genetics & Heredity
Sarah Burke, Maureen Mork, Krista Qualmann, Ashley Woodson, Min Jin Ha, Banu Arun, Meagan Kaulfus
Summary: Most clinical cancer genetics experts recommend clinical-grade confirmatory testing for patients who have obtained positive results from direct-to-consumer genetic testing (DTC-GT) or third-party interpretation (TPI) services. However, there is strong variability in the type of recommended testing, with differences between single-site analysis, founder mutation testing, BRCA1/2 testing, and multi-gene panel testing among genetic counselors. This variability in testing strategies may impact counseling approaches and consensus for this expanding group of patients.
JOURNAL OF GENETIC COUNSELING
(2021)
Article
Obstetrics & Gynecology
Benjamin J. Peipert, Benjamin S. Harris, Jessica H. Selter, Khaila Ramey-Collier, Randa Blenden, Shakthi Unnithan, Alaattin Erkanli, Thomas M. Price
Summary: The study found that infertility patients commonly utilize various methods of ovulation prediction. However, there is significant discordance in the perceived utility of direct-to-consumer fertility tests between patients and reproductive endocrinologists. Patient education and guidelines are needed to better inform individuals considering direct-to-consumer fertility tests.
REPRODUCTIVE BIOMEDICINE ONLINE
(2023)
Article
Ethics
Louiza Kalokairinou, Patricia J. Zettler, Ashwini Nagappan, Moira A. Kyweluk, Anna Wexler
Summary: This article discusses the challenges and regulatory issues in the field of COVID-19 testing, emphasizing the impact of the emergence of the DTC testing market on the diagnostic and serological testing arena. It also highlights several key challenges such as test accuracy, privacy concerns, resource allocation, and provides recommendations for regulators and companies.
JOURNAL OF LAW AND THE BIOSCIENCES
(2021)
Article
Medical Laboratory Technology
Matthias Orth, Erik Vollebregt, Tomaso Trenti, Patti Shih, Mette Tollanes, Sverre Sandberg
Summary: In vitro diagnostics (IVD) testing is a powerful tool for medical diagnosis, but direct-to-consumer laboratory testing (DTCT) may pose risks to lay persons using and relying on it for healthcare decision-making. Without effective competent authority oversight, caution must be exercised when introducing new DTCTs. Laboratory medicine specialists should feel obligated to warn and educate patients and the public about the risks of inappropriate and harmful DTCTs.
CLINICAL CHEMISTRY AND LABORATORY MEDICINE
(2023)
Review
Medicine, General & Internal
Kirpal S. Panacer
Summary: Direct-to-consumer genetic testing (DTC-GT) is a profitable private enterprise that offers genetic testing kits directly to consumers. These companies claim to empower patients to take control of their health and explore their disease risk and ancestry. However, consumers may have limited understanding of the services and the testing methods used may have limitations, potentially causing harm. The utilization of data gathered may also reinforce negative stereotypes and raise ethical concerns. This review provides an overview of the services offered by DTC-GT companies and addresses important ethical issues associated with these services.
CUREUS JOURNAL OF MEDICAL SCIENCE
(2023)
