Public reactions to direct-to-consumer genetic health tests: A comparison across the US, UK, Japan and Australia.

While direct to consumer health-related genetic testing (DTCGT) has potential to provide accessible genetic information and empower individuals to make informed healthcare decisions, it attracts concern associated with regulatory gaps, clinical utility and potential for harm. Understanding public reactions to DTCGT is vital to facilitate considered regulatory, health care and consumer protection strategies. Yet little is known, particularly outside the dominant US market, about how the general public view and might engage with DTCGT outside traditional health care systems. This paper addresses this knowledge gap with the first empirical study to investigate general public views across four countries, each at different stages of market development. US (n = 1000), UK (n = 1014), Japanese (n = 1018) and Australian (n = 1000) respondents completed an online experimental survey assessing comprehension, risk perceptions, and potential psychological and behavioural outcomes by type of test (disease pre-disposition and drug sensitivity), severity, lifestyle factors, and family history. Results showed generally low awareness and intention to purchase across countries, highest in the US and lowest in Japan. Results also showed clear preference for within-country purchases (less in Japan), with reports returned via doctors far more important in Japan. All respondents were more likely to act on test results, where there was higher genetic or lifestyle risk of developing a disease. Statistical comparisons of demographic and health-related variables across countries point to the need for further analyses designed to explain much needed cross-cultural, cross-health care system and developed versus developing market differences.

All your data (effectively) belong to us: data practices among direct-to-consumer genetic testing firms.

PURPOSE: Direct-to-consumer genetic testing (DTC-GT) has become a convenient method to help people to understand their genetic makeup. Owing in part to concerns regarding confidentiality, privacy, and secondary use of data, professional and government bodies created guidelines to promote transparency among these companies. Using a comprehensive and systematic approach, this study assessed DTC-GT company compliance with international transparency guidelines. METHODS: A framework analysis was performed on 30 DTC-GT health and/or ancestry websites identified using a US-based online search strategy during the summer of 2015. A codebook was developed from a synthesis of relevant guidelines from seven DTC-GT guideline documents and applied to each website. RESULTS: Although most companies met guidelines related to transparency regarding security protocols, storage procedures, and third-party disclosures, few met guidelines regarding sharing risks from data disclosures. Additionally, few companies disclosed how long data would be kept for services or research. Use of data for research was frequently mentioned only in privacy policies and terms of service documents, and only two-thirds of companies required an additional consent to use consumer data for health-related research. CONCLUSION: Our analysis shows that DTC-GT companies do not consistently meet international transparency guidelines related to confidentiality, privacy, and secondary use of data.Genet Med advance online publication 22 September 2016.

A survey of direct-to-consumer teledermatology services available to US patients: Explosive growth, opportunities and controversy.

Introduction Direct-to-consumer (DTC) teledermatology is radically changing the way patients obtain dermatological care. Now, with a few clicks, patients can obtain dermatological consultations and prescription medications without a prior physician-patient relationship. To analyse all DTC teledermatology services available to US patients. Methods We performed Internet searches to identify DTC teledermatology services available through Internet webpages or through smartphone applications. For each service, the scope of care provided, cost, wait times, prescription policies and other relevant information were recorded. Results Twenty-two DTC teledermatology services are available to US patients in 45 states. Six (27%) services offer care from international physicians. Sixteen (73%) services allow patients to seek care for any reason, while six (27%) limit care to acne or anti-aging. The median reported response time for DTC teledermatology services is 48 hours from the time of patient request. The median consultation fee for companies providing care from US board-certified physicians is US$59. Across all services, consultation fees range from US$1.59 to US$250. Conclusions DTC teledermatology services are readily available to patients in most states. These services may reduce the cost of patient visits, expand access to care and increase patient convenience. However, the presence of services staffed by physicians who are not US board-certified, as well as the use of incautious language regarding prescription medications, is concerning.

Direct-to-consumer teledermatology services for pediatric patients: Room for improvement.

Direct-to-consumer teledermatology is radically changing the way some patients obtain dermatologic care. Many direct-to-consumer teledermatology services offer care to patients younger than 18 years, but policies and standards are nonuniform. For pediatric patients, direct-to-consumer teledermatology is a substantial departure from in-person care. More consensus, standards, and guidelines are necessary.

Content Analysis of Informed Consent for Whole Genome Sequencing Offered by Direct-to-Consumer Genetic Testing Companies.

Whole exome sequencing (WES) and whole genome sequencing (WGS) have become increasingly available in the research and clinical settings and are now also being offered by direct-to-consumer (DTC) genetic testing (GT) companies. This offer can be perceived as amplifying the already identified concerns regarding adequacy of informed consent (IC) for both WES/WGS and the DTC GT context. We performed a qualitative content analysis of Websites of four companies offering WES/WGS DTC regarding the following elements of IC: pre-test counseling, benefits and risks, and incidental findings (IFs). The analysis revealed concerns, including the potential lack of pre-test counseling in three of the companies studied, missing relevant information in the risks and benefits sections, and potentially misleading information for consumers. Regarding IFs, only one company, which provides opportunistic screening, provides basic information about their management. In conclusion, some of the information (and related practices) present on the companies' Web pages salient to the consent process are not adequate in reference to recommendations for IC for WGS or WES in the clinical context. Requisite resources should be allocated to ensure that commercial companies are offering high-throughput sequencing under responsible conditions, including an adequate consent process.

Current landscape of direct-to-consumer genetic testing and its role in ophthalmology: a review.

The sequencing of the human genome has seen the emergence of the direct-to-consumer (DTC) genetic-testing market, which allows individuals to obtain information about their genetic profile and its many health and lifestyle implications. Genetics play an important role in the development of many eye diseases, however, little information is available describing the influence of the DTC industry in ophthalmology. In this review, we examined DTC companies providing genetic test products for eye disease. Of all eye conditions, the majority of DTC companies provided susceptibility testing or risk assessment for age-related macular degeneration (AMD). For the 15 companies noted to offer products, we found considerable variation in the cost, scope and clarity of informational content of DTC genetic testing for ophthalmic conditions. The clinical utility of these tests remains in question, and the American Academy of Ophthalmology recommendations against routine testing for many conditions probably still apply.