Awareness, Attitudes and Perspectives of Direct-To-Consumer Genetic Testing in Greece: a Survey of Potential Consumers

Journal of Human Genetics (2015) 60, 515–523 & 2015 The Japan Society of Human Genetics All rights reserved 1434-5161/15 www.nature.com/jhg ORIGINAL ARTICLE Awareness, attitudes and perspectives of direct-to-consumer genetic testing in Greece: a survey of potential consumers Vasiliki Mavroidopoulou1, Ellie Xera1 and Vasiliki Mollaki1,2 Direct-to-consumer genetic testing (DTCGT) is now offered by numerous companies. The present survey aimed to explore awareness, interest, reasons to take and refuse DTCGT, and understanding of results amongst 725 higher education students in Greece. A third of the responders were aware of DTCGT and interest was dependent on cost. More than 60% of the participants would undergo DTCGT to learn more about their health, to warn their children, so that their doctor can monitor their health and change their lifestyle. Nevertheless, they would prefer to consult their doctor first and expressed concerned about their personal data. After receiving results from a hypothetical DTC genetic test predicting higher risk for colon cancer, 59.5% of the responders thought that they could understand the results but 46.1% believed that the results have diagnostic value. In total, 83.6% of the participants would ask their doctor to explain the results and 70.4% would discuss results with their family. In conclusion, the majority of higher education students in Greece appreciate the benefits of genetic testing but with the involvement of their doctor. A physician’s participation in the process and informing the public about the true value of genetic testing, are crucial to avoid misinterpretation of DTCGT results. Journal of Human Genetics (2015) 60, 515–523; doi:10.1038/jhg.2015.58; published online 4 June 2015 INTRODUCTION test for health-related purposes.4 In 2013, the US Food and Drug The impact of genetic information on disease diagnosis and preven- Administration (FDA) sent a letter to 23andMe (Mountain View, CA, tion, the promises of personalized medicine, the public’sincreasing USA), one of the biggest companies offering DTCGT services, interest in genetic information, along with the increasing number of ordering the company to discontinue marketing of the Personal companies offering genetic services and the promotion and marketing Genome Service until it receives FDA marketing authorization for the campaigns, are some of the main reasons that lead to the advent of device.5 The FDA’s warning further contributed to the discussion direct-to-consumer genetic testing (DTCGT).1 During the last decade, about whether DTCGT can be used without professional supervision. the market of DTCGT has been growing1,althoughsomestudies However, this is not the case for companies offering DTCGT outside suggest that the market specifically for DTC genetic susceptibility tests the USA borders, such as Europe, and especially for smaller companies for complex diseases is much smaller than previously suggested.2 offering these services. However, the number of private companies offering DTCGT Regulation of DTCGT services received attention in the USA since increases, with a wide variation in the provided tests including 2010, but only four European countries (France, Germany, Portugal genome-wide analysis, single-gene disorders, predisposition to com- and Switzerland) have specific legislation that requires a medical plex diseases, paternity tests, pharmacogenomics, nutrigenomics and doctor to carry out genetic tests and two countries (Belgium and UK) genealogy tests, which are all purchased directly by the consumer allow DTCGT.6 The rapid growth of the DTCGT market7 triggered through the internet.3 As the cost of genetic testing decreases, the cost increasing attention from the scientific community, Ethics Commit- of DTCGT is expected to fall dramatically and therefore, become more tees or Advisory Boards from European countries including Greece8, accessible to consumers. Italy9, Portugal10, Belgium11,Austria12,Denmark13, Finland14,the At the advent of DTCGT services, the main difference between Netherlands15,UK16, as well as non-European such as Australia,17 by conventional genetic testing and DTCGT was that the latter was issuing opinions or position papers that emphasized the ethical issues offered without prior or subsequent involvement of a healthcare raised by DTCGT and suggested a closer regulatory oversight. professional. More recently, and only after great legal battles, the According to a 2012 Report for the Hellenic National Bioethics biggest companies offering DTCGT services in the USA adhered to the Commission, 15 private companies offered DTCGT services in Greece, requirement to have a physician involved in the process of ordering a which is a relatively small country with a population of 11 million.18 1Department of Medical Laboratories, Faculty of Health and Caring Professions, Technological Educational Institution of Athens, Athens, Greece and 2Hellenic National Bioethics Commission, Athens, Greece Correspondence: Dr V Mollaki, Hellenic National Bioethics Commission, Neofytou Vamva 6, Athens 10674, Greece. E-mail: [email protected] Received 20 January 2015; revised 16 March 2015; accepted 30 April 2015; published online 4 June 2015 Awareness and perspectives of DTCGT in Greece V Mavroidopoulou et al 516 These were private companies with Greek websites offering genetic participants summarized as follows: ‘Imagine that you see an advertisement on services via a kit for sample collection by the consumer. The services the internet about a genetic test that predicts risk to colon cancer. The test included tests for paternity, kinship, predisposition to complex includes a kit with a swab to collect a biological sample from the inside of the diseases, pharmacogenetics, athletic performance, predisposition to cheek, which is then sent back to the company by post. The company will study single-gene diseases, nutritional or metabolic tests, anti-ageing tests, whether there are genetic defects that confer an increased risk to develop colon cancer. Along with the biological sample, the company required that you genealogy tests and whole-genome analysis. Only 26.6% of these completed a short questionnaire about your lifestyle and family history. companies had laboratories accredited according to international Imagine that you already know that one of your close relatives developed 18 standards. According to their websites, the companies that were colon cancer, and you take the decision to do the genetic test. One week later included in the Report did not have a physician or healthcare you receive the genetic results by e-mail, according to which you have a twofold professional involved in the process of ordering a test for health- increased risk to develop colon cancer compared to the general population’. related purposes. To address the above issues, the Hellenic National The last 13 questions assessed understanding of the DTCGT results and their Bioethics Commission issued a Statement of Opinion on DTCGT impact on psychology and future actions of the participants. Some questions emphasizing the fact that there is no involvement of a healthcare remained the same prior to- and following the hypothetical scenario to explore provider before or after undertaking the test, which may lead to whether their views changed in the context of having a high risk for a serious disease, such as colon cancer. Approximately 7 min were needed to complete unnecessary testing and misinterpretation of the results.8 the questionnaire. Yet to date, there is limited information on the awareness and interest of consumers in DTCGT in Greece and generally in European 19 Statistical analysis countries. As the process of consultation and possible regulation of Statistical analysis was performed using the SPSS software (v17.0) (IBM, DTCGT evolves, it is vital to record awareness, interest and under- Armonk, NY, USA). Descriptive statistics were calculated to summarize the standing of DTCGT results in European countries. To our knowledge, characteristics and the answers of the responders. The Pearson’s χ2 test was this is the first survey in Greece that specifically investigates awareness, used to compare differences between answers at P ⩽ 0.05 level of significance. interest, motivations and understanding of DTCGT. The present study To facilitate comparisons, for the Pearson’s χ2 in the Likert questions the also aimed to compare the results from Greece with similar studies in response category ‘Very likely’ was merged with ‘Fairly likely’ and the response ‘ ’ ‘ ’ other European and non-European studies. category Not very likely was merged with Unlikely .Similarly,theresponse ‘ ’ ‘ ’ Higher education students have been previously used as the study category Strongly agree was merged with Agree and the response category ‘Disagree’ was merged with ‘Strongly disagree’. population to examine attitudes to DTCGT.20,21 Higher educational level, internet use and young age have been previously determined as RESULTS demographic characteristics which are likely to be shared by prospec- Demographic characteristics of participants tive users of DTCGT services.21,22 Therefore, we chose higher The demographic characteristics of the responders are shown in education students (university and college students) as the study Table 1. Most of the students were of Greek origin, o25 years of age, population for the following reasons: (i) because of their young age, females, not married, without children and in their undergraduate students are familiar with using internet services

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