Direct-to-Consumer Genetic Testing: A Systematic Review of European Guidelines, Recommendations, and Position Statements

Abstract

Professional societies and associations are currently more suggestive of potential disadvantages of DTC GT, recommending improved genetic literacy of both populations and health professionals, and implementation research on the genetic tests to integrate public health genomics into healthcare systems.

Transparency of genetic testing services for ‘health, wellness and lifestyle’: analysis of online prepurchase information for UK consumers

“…This fragmentation has also been described in a recent systematic review of European guidelines, recommendations and position statements. 12 Our assessment was based on a simple, actionable, yes/no checklist. We did not specifically examine the fitness-for-purpose of contract language relevant to the HGC principles and this would merit further study.…”

“…In this respect, it has been observed that numerous European policy reports on DTC-GT have been written but few have been implemented. 12 We recommend new efforts to agree minimum standards of transparency and quality, with appropriate mechanisms of review and certification of DTC-GT providers to increase the accountability of companies active in the DTC-GT market. Providing an independent trusted quality mark would benefit both consumers and health-care professionals dealing with questions from patients who have purchased or are thinking of purchasing DTC-GT services.…”

“…For example, concerns about such products and services can span in vitro medical device safety, consumer rights, fair advertising and data protection. [9][10][11][12] To compound this, services sold online in one country may be underpinned by operations located in other regions with different regulatory jurisdictions, making it difficult for consumers to easily judge their rights for protection and recourse. Mindful of liability risks, many DTC-GT companies are marketing their services as 'information products' rather than medical products, with the intent of them being 'for educational purposes only' and stipulate that the test results are not for diagnostic use.…”

Direct-to-consumer carrier screening for cystic fibrosis via a hospital website: a 6-year evaluation

“…DTC testing has been criticized by both professional and public bodies (Rafiq et al 2015; Skirton et al 2012). Concerns have been expressed about the pre- and post-test information and counseling; medical supervision; consumer’s privacy and confidentiality; the test’s quality; and the possible impact on regular healthcare (Borry et al 2011; Skirton et al 2012).…”

Health in exchange for privacy : the adoption of personalised nutrition advices

“…Although the use of genetic information for health purposes such as tailored dietary recommendations has been around for more than a decade (Rafiq, Ianuale, Ricciardi, & Boccia, 2015;Stover, 2004), this dissertation shows that the extent to which individuals know and understand the relevance of genetic information for the formation of meaningful dietary recommendation is limited. In addition, our findings show that personalised nutrition advice that is based on genotypic information significantly increases risk perceptions without enhancing perceptions of benefit.…”