Personal Genomics in Greece: An Overview of Available Direct-to-Consumer Genomic Services and the Relevant Legal Framework

Kechagia, Sotiria; Mai, Yuan; Vidalis, Takis; Patrinos, George P.; Vayena, Effy

doi:10.1159/000366175

Cited by 10 publications

(5 citation statements)

References 18 publications

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“…Both studies emphasized a lack of exhaustive information on the privacy policy regarding minors, which is a deviation from the professional guidelines on this issue. Also, in a recent systematic Internet search for DTC genomic services, limited information on privacy policies was found [ 120 ]. This evidence contrasts with other studies that found the majority of sites selected provided this information [ 115 - 117 , 121 , 122 ].…”

Section: Resultsmentioning

confidence: 99%

See 1 more Smart Citation

Internet-Based Direct-to-Consumer Genetic Testing: A Systematic Review

Covolo¹,

Rubinelli²,

Ceretti³

et al. 2015

J Med Internet Res

115

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BackgroundDirect-to-consumer genetic tests (DTC-GT) are easily purchased through the Internet, independent of a physician referral or approval for testing, allowing the retrieval of genetic information outside the clinical context. There is a broad debate about the testing validity, their impact on individuals, and what people know and perceive about them.ObjectiveThe aim of this review was to collect evidence on DTC-GT from a comprehensive perspective that unravels the complexity of the phenomenon.MethodsA systematic search was carried out through PubMed, Web of Knowledge, and Embase, in addition to Google Scholar according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist with the key term “Direct-to-consumer genetic test.”ResultsIn the final sample, 118 articles were identified. Articles were summarized in five categories according to their focus on (1) knowledge of, attitude toward use of, and perception of DTC-GT (n=37), (2) the impact of genetic risk information on users (n=37), (3) the opinion of health professionals (n=20), (4) the content of websites selling DTC-GT (n=16), and (5) the scientific evidence and clinical utility of the tests (n=14). Most of the articles analyzed the attitude, knowledge, and perception of DTC-GT, highlighting an interest in using DTC-GT, along with the need for a health care professional to help interpret the results. The articles investigating the content analysis of the websites selling these tests are in agreement that the information provided by the companies about genetic testing is not completely comprehensive for the consumer. Given that risk information can modify consumers’ health behavior, there are surprisingly few studies carried out on actual consumers and they do not confirm the overall concerns on the possible impact of DTC-GT. Data from studies that investigate the quality of the tests offered confirm that they are not informative, have little predictive power, and do not measure genetic risk appropriately.ConclusionsThe impact of DTC-GT on consumers’ health perceptions and behaviors is an emerging concern. However, negative effects on consumers or health benefits have yet to be observed. Nevertheless, since the online market of DTC-GT is expected to grow, it is important to remain aware of a possible impact.

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Section: Resultsmentioning

confidence: 99%

“…Very little information or scientific evidence was provided on the clinical validity of tests [ 114 - 117 , 121 - 123 , 128 ]. Some websites referred to a laboratory certification, such as Clinical Laboratory Improvement Amendments (CLIA) standards, to indicate legitimacy [ 114 , 115 , 117 , 120 - 122 , 124 , 128 ].…”

Section: Resultsmentioning

confidence: 99%

Internet-Based Direct-to-Consumer Genetic Testing: A Systematic Review

Covolo¹,

Rubinelli²,

Ceretti³

et al. 2015

J Med Internet Res

115

View full text Add to dashboard Cite

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“…Although stringent standards apply to genetic testing conducted in Australia, the TGA and other regulators are not empowered to prevent access to or regulate the quality of Internet-based DTC genetic tests conducted overseas. Similar issues are faced by other international regulators ( 9 ), with issues reported such as difficulties determining whether DTC samples were being processed locally or sent overseas ( 11 ). Given the challenges of genomic literacy in the general population ( 19 , 20 ), many consumers may not be aware of the quality of online genetic tests.…”

Section: Concerns With Unaccredited Internet-based Dtc Genetic Testsmentioning

confidence: 89%

Regulation of Internet-based Genetic Testing: Challenges for Australia and Other Jurisdictions

Tiller

Lacaze

2018

Front. Public Health

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The Internet currently enables unprecedented ease of access for direct-to-consumer (DTC) genetic testing, with saliva collection kits posted directly to consumer homes from anywhere in the world. This poses new challenges for local jurisdictions in regulating genetic testing, traditionally a tightly-regulated industry. Some Internet-based genetic tests have the capacity to cause significant confusion or harm to consumers who are unaware of the risks or potential variability in quality. The emergence of some online products of questionable content, unsupported by adequate scientific evidence, is a cause for concern. Proliferation of such products in the absence of regulation has the potential to damage public trust in accredited and established clinical genetic testing during a critical period of evidence generation for genomics. Here, we explore the challenges arising from the emergence of Internet-based DTC genetic testing. In particular, there are challenges in regulating unaccredited or potentially harmful Internet-based DTC genetic testing products. In Australia, challenges exist for the Therapeutic Goods Administration, which oversees regulation of the genetic testing sector. Concerns and challenges faced in Australia are likely to reflect those of other comparable non-US jurisdictions. Here, we summarize current Australian regulation, highlight concerns, and offer recommendations on how Australia and other comparable jurisdictions might be more proactive in addressing this emerging public health issue.

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“…15 Also, we used structured questionnaires, face-to-face interviews, and surveys to assess the opinion and standpoint of the various stakeholders in Greece, such as the Ministry of Health, National Medicines Organization, payers and insurance companies, and others. 16 Lastly, we have documented the existing genetic laboratories in Greece 17,18 and currently, this information is being compiled into a data repository to be directly assessible from the general public and clinicians. Through the use of questionnaires and structured surveys, we have assessed the level of genomics awareness and genetic education of the general public and of healthcare professionals, respectively, [19][20][21] and evaluated the academic educational environment in Greece as far as pharmacogenomics is concerned, both at the under-and post-graduate levels 22 and we have developed elearning courses in the field of genomic medicine ensuring continuous medical education of interested healthcare professionals and biomedical scientists.…”

Section: Key Componentsmentioning

confidence: 99%

Roadmap for Establishing Large-Scale Genomic Medicine Initiatives in Low- and Middle-Income Countries

Patrinos

Pasparakis²,

Koiliari³

et al. 2020

The American Journal of Human Genetics

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In the post-genomic era, genomic medicine interventions as a key component of personalized medicine and tailored-made health care are greatly anticipated following recent scientific and technological advances. Indeed, large-scale sequencing efforts that explore human genomic variation have been initiated in several, mostly developed, countries across the globe, such as the United States, the United Kingdom, and a few others. Here, we highlight the successful implementation of large-scale national genomic initiatives, namely the Genome of Greece (GoGreece) and the DNA do Brasil (DNABr), aiming to emphasize the importance of implementing such initiatives in developing countries. Based on this experience, we also provide a roadmap for replicating these projects in other low-resource settings, thereby bringing genomic medicine in these countries closer to clinical fruition.

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Personal Genomics in Greece: An Overview of Available Direct-to-Consumer Genomic Services and the Relevant Legal Framework

Cited by 10 publications

References 18 publications

Internet-Based Direct-to-Consumer Genetic Testing: A Systematic Review

Internet-Based Direct-to-Consumer Genetic Testing: A Systematic Review

Regulation of Internet-based Genetic Testing: Challenges for Australia and Other Jurisdictions

Roadmap for Establishing Large-Scale Genomic Medicine Initiatives in Low- and Middle-Income Countries

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