References
- Smart A , BolnickDA , TuttonR . Health and genetic ancestry testing: time to bridge the gap . BMC Med. Genomics10 ( 3 ), 1 – 9 ( 2017 ).
- Human Genetics Commission . A common framework of principles for genetic testing services ( 2010 ). www.cellmark.co.uk/pdfs/HGCprinciples.pdf .
- Howard HC , BorryP . Is there a doctor in the house?: the presence of physicians in the direct-to-consumer genetic testing context . J. Community Genet.3 ( 2 ), 105 – 112 ( 2012 ).
- Hogarth S , JavittG , MelzerD . The current landscape for direct-to-consumer genetic testing: legal, ethical, and policy issues . Annu. Rev. Genomics Hum. Genet.9 , 161 – 182 ( 2008 ).
- Williams-Jones B . Re-framing the discussion: commercial genetic testing in Canada . Heal. Law J.7 , 49 – 67 ( 1999 ).
- Gollust SE , WilfondBS , HullSC . Direct-to-consumer sales of genetic services on the Internet . Genet. Med.5 ( 4 ), 332 – 337 ( 2003 ).
- Phillips AM . Genomic privacy and direct-to-consumer genetics: big consumer genetic data – what’s in that contract? Presented at : IEEE Security and Privacy Workshop , 60 – 64 , CA, USA , 21–22 May 2015 .
- Graceful Earth . Alzheimer’s test ( 2017 ). http://gracefulearth.com/alzheimerstest.aspx .
- Invitae . Test catalogue – cardiology ( 2017 ). www.invitae.com/en/physician/category/CAT000001/#category-content-CAT000008 .
- 23andMe . “What you can expect?” ( 2017 ). www.23andme.com/en-gb/health/reports/ .
- Niemiec E , BorryP , PinxtenW , HowardHC . Content analysis of informed consent for whole genome sequencing offered by direct-to-consumer genetic testing companies . Hum. Mutat.37 ( 12 ), 1248 – 1256 ( 2016 ).
- Counsyl ( 2017 ). www.counsyl.com/services/family-prep-screen/ .
- Veritas Genetics . myPrenatal ( 2017 ). www.veritasgenetics.com/myprenatal .
- Illumina . Preconception and fertility ( 2017 ). www.illumina.com/clinical/reproductive-genetic-health/preconception-fertility.html .
- Baby Genes ( 2017 ). www.babygenes.net/ .
- Simplified Genetics ( 2017 ). www.simplifiedgenetics.com/simply-safe.html .
- 23andMe . Accessing your-raw data ( 2017 ). https://customercare.23andme.com/hc/en-us/articles/202907670-Accessing-your-Raw-Data .
- Promethease ( 2017 ). https://promethease.com/ .
- LiveWello ( 2017 ). https://livewello.com/genetics .
- Genetic Genie ( 2017 ). http://geneticgenie.org/ .
- Sequencing ( 2017 ). https://sequencing.com/hello .
- openSNP ( 2017 ). https://opensnp.org/ .
- DNA.Land ( 2017 ). https://dna.land/ .
- 23andMe Media Center . “23andMe enables genetic research for ResearchKit Apps” ( 2017 ). https://mediacenter.23andme.com/blog/researchkit/ .
- Roberts JL , PereiraS , McGuireAL . Should you profit from your genome?Nat. Biotechnol.35 ( 1 ), 18 – 20 ( 2017 ).
- Kalokairinou L , HowardHC , BorryP . Direct-to-consumer genetic testing . In: eLS . John Wiley & Sons, Ltd , Chichester, UK ( 2014 ).
- Tamir S . Direct-to-consumer genetic testing: ethical-legal perspectives and practical considerations . Med. Law Rev.18 ( 2 ), 213 – 238 ( 2010 ).
- Gollust SE , HullSC , WilfondBS . Limitations of direct-to-consumer advertising for clinical genetic testing . J. Am. Med. Assoc.288 ( 14 ), 1762 – 1767 ( 2002 ).
- Goldsmith L , JacksonL , O’ConnorA , SkirtonH . Direct-to-consumer genomic testing from the perspective of the health professional: a systematic review of the literature . J. Community Genet.4 ( 2 ), 169 – 180 ( 2013 ).
- Roberts JS , OstergrenJ . Direct-to-consumer genetic testing and personal genomics services: a review of recent empirical studies . Curr. Genet. Med. Rep.1 ( 3 ), 182 – 200 ( 2013 ).
- European Society of Human Genetics . Statement of the ESHG on direct-to-consumer genetic testing for health-related purposes . Eur. J. Hum. Genet.18 ( 12 ), 1271 – 1273 ( 2010 ).
- European Academies Science Advisory Council . Direct-to-consumer genetic testing ( 2012 ). www.feam-site.eu/cms/docs/publications/EasacFeam_Genetic_TestingJuly2012.pdf .
- U.S. Food and Drug Administration . Warning Letter to 23andMe ( 2013 ). www.fda.gov/iceci/enforcementactions/warningletters/2013/ucm376296.htm .
- Burke W , TrinidadSB . The deceptive appeal of direct-to-consumer genetics . Ann. Intern. Med.164 ( 8 ), 564 – 566 ( 2016 ).
- Borry P , SénécalK , KnoppersBM . Do it yourself newborn screening . JAMA Pediatr.170 ( 6 ), 523 – 524 ( 2016 ).
- Laestadius LI , RichJR , AuerPL . All your data (effectively) belong to us: data practices among direct-to-consumer genetic testing firms . Genet. Med.19 ( 5 ), 513 – 520 ( 2017 ).
- McGuire AL , BurkeW . Health system implications of direct-to-consumer personal genome testing . Public Health Genomics.14 ( 1 ), 53 – 58 ( 2011 ).
- Janssens ACJW , GwinnM , BradleyLA , OostraBA , van DuijnCM , KhouryMJ . A critical appraisal of the scientic basis of commercial genomic profiles used to assess health risks and personalize health interventions . Am. J. Hum. Genet.82 , 593 – 599 ( 2008 ).
- Kirkpatrick BE , RashkinMD . Ancestry testing and the practice of genetic counseling . J. Genet. Couns.26 ( 1 ), 6 – 10 ( 2016 ).
- FDA News Release . “FDA permits marketing of first direct-to-consumer genetic carrier test for Bloom syndrome” ( 2015 ). www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/UCM435003 .
- 23andMe . Select your location ( 2017 ). www.23andme.com/en-gb/ .
- U.S. Food and Drug Administration . “FDA allows marketing of first direct-to-consumer tests that provide genetic risk information for certain conditions.” ( 2017 ). www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm551185.htm .
- Goldman JS , HahnSE , CataniaJWet al. Genetic counseling and testing for Alzheimer disease: joint practice guidelines of the American College of Medical Genetics and the National Society of Genetic Counselors . Genet. Med.13 ( 6 ), 597 – 605 ( 2011 ).
- Thorogood A , Cook-DeeganR , KnoppersBM . Public variant databases: liability?Genet. Med.19 ( 7 ), 838 – 841 ( 2016 ).
- Gene by Gene . Terms & conditions ( 2017 ). www.genebygene.com/pages/terms .
- Skirton H , JacksonL , GoldsmithL , O’ConnorA . Are health professionals ready for direct-to-consumer genetic and genomic testing?Pers. Med.10 ( 7 ), 673 – 682 ( 2013 ).
- Gene-Equip . Genetics education for primary care ( 2017 ). www.primarycaregenetics.org/?page_id=109&lang=en .
- NICE – National Institute for Health and Care Excellence ( 2017 ). www.nice.org.uk/ .
- Middleton A , MendesÁ , BenjaminCM , HowardHC . Direct-to-consumer genetic testing: where and how does genetic counseling fit?Pers. Med.14 ( 3 ), 249 – 257 ( 2017 ).
- Pinxten W , HowardHC . Ethical issues raised by whole genome sequencing . Best Pract. Res. Clin. Gastroenterol.28 ( 2 ), 269 – 279 ( 2014 ).
- The Human Tissue Authority . Human Tissue Act ( 2004 ). www.legislation.gov.uk/ukpga/2004/30/contents .
- U.S. Government Accountability Office . Direct-to-consumer genetic tests misleading test results are further complicated by deceptive marketing and other questionable practices ( 2010 ). www.gao.gov/assets/130/125079.pdf .
- Singleton A , ErbyLH , FoisieKV , KaphingstKA . Informed choice in direct-to-consumer genetic testing (DTCGT) websites: a content analysis of benefits, risks, and limitations . J. Genet. Couns.21 ( 3 ), 433 – 439 ( 2012 ).
- Borry P , ShabaniM , HowardHC . Nonpropositional content in direct-to-consumer genetic testing advertisements . Am. J. Bioeth.13 ( 5 ), 14 – 16 ( 2013 ).
- Skirton H , GoldsmithL , JacksonL , LewisC , ChittyLS . Non-invasive prenatal testing for aneuploidy: a systematic review of internet advertising to potential users by commercial companies and private health providers . Prenat. Diagn.35 ( 12 ), 1167 – 1175 ( 2015 ).
- Borry P , GoffinT , NysH , DierickxK . Predictive genetic testing in minors for adult-onset genetic diseases . Mt Sinai J. Med.75 , 287 – 296 ( 2008 ).
- Howard HC , AvardD , BorryP . Are the kids really all right? Direct-to-consumer genetic testing in children: are company policies clashing with professional norms?Eur. J. Hum. Genet.19 ( 11 ), 1122 – 1126 ( 2011 ).
- Borry P , HowardHC , SénécalK , AvardD . Health-related direct-to-consumer genetic testing: a review of companies’ policies with regard to genetic testing in minors . Fam. Cancer9 ( 1 ), 51 – 59 ( 2010 ).
- PHG Foundation . Data sharing to support UK clinical genetics and genomics services ( 2015 ). www.phgfoundation.org/file/17089/ .
- Gymrek M , McGuireAL , GolanD , HalperinE , ErlichY . Identifying personal genomes by surname inference . Science.339 ( 6117 ), 321 – 324 ( 2013 ).
- Knoppers BM . Framework for responsible sharing of genomic and health-related data . Hugo J.8 ( 3 ), 1 – 6 ( 2014 ).
- Tobin SL , ChoMK , LeeSS-Jet al. Customers or research participants?: guidance for research practices in commercialization of personal genomics . Genet. Med.14 ( 10 ), 833 – 835 ( 2012 ).
- Howard HC , KnoppersBM , BorryP . Blurring lines. The research activities of direct-to-consumer genetic testing companies raise questions about consumers as research subjects . EMBO Rep.11 ( 8 ), 579 – 582 ( 2010 ).
- 23andMe . Collaborations ( 2017 ). http://researchers.23andme.org/collaborations .
- Adam S , FriedmanJM . Individual DNA samples and health information sold by 23andMe . Genet. Med.18 ( 4 ), 305 – 306 ( 2016 ).
- Niemiec E , HowardHC . Ethical issues in consumer genome sequencing: use of consumers’ samples and data . Appl. Transl. Genomics.8 , 23 – 30 ( 2016 ).
- Sterckx S , CockbainJ , HowardH , HuysI , BorryP . “Trust is not something you can reclaim easily”: patenting in the field of direct-to-consumer genetic testing . Genet. Med.15 ( 5 ), 382 – 387 ( 2013 ).
- Sharon T . The Googlization of health research: from disruptive innovation to disruptive ethics . Pers. Med.16 ( 6 ), 563 – 574 ( 2016 ).
- Godard B , KääriäinenH , KristofferssonU , TranebjaergL , CovielloD , AymeS . Provision of genetic services in Europe: current practices and issues . Eur. J. Hum. Genet.11 , S13 – S48 ( 2003 ).
- Fact sheets on the European Union . “The principle of subsidiarity.” ( 2017 ). www.europarl.europa.eu/ftu/pdf/en/FTU_1.2.2.pdf .
- Borry P , van HellemondtRE , SprumontDet al. Legislation on direct-to-consumer genetic testing in seven European countries . Eur. J. Hum. Genet.20 ( 7 ), 715 – 721 ( 2012 ).
- PHG Foundation . “Ban on direct-to-consumer in Germany.” ( 2009 ). www.phgfoundation.org/news/4562/ .
- Castle BG , BlaneyR . “European Union regulation of in vitro diagnostic medical devices” . In : In Vitro Diagnostics: The Complete Regulatory Guide . DanzisSD , FlanneryEJ ( Eds ). Food and Drug Law Institute , DC, USA , 227 – 252 ( 2010 ).
- European Commission . “Consumer rights and law”, Europa ( 2016 ). http://ec.europa.eu/consumers/consumer_rights/index_en.htm .
- Directive 2005/29/EC of the European Parliament and of the Council of 11 May 2005 concerning unfair business-to-consumer commercial practices in the Internal market ( 2005 ). http://eur-lex.europa.eu/legal-content/en/TXT/?uri=CELEX:32005L0029 .
- Directive 2011/83/EU of the European Parliament and of the Council of 25 October 2011 on consumer rights ( 2011 ). http://eur-lex.europa.eu/legal-content/en/TXT/?uri=CELEX:32011L0083 .
- Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices ( 1998 ). http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:31998L0079 .
- Sholz N . “Medical devices and in vitro diagnostic medical devices” European Parliamentary Research Service ( 2016 ). www.europarl.europa.eu/RegData/etudes/BRIE/2016/583812/EPRS_BRI(2016)583812_EN.pdf .
- Kalokairinou L , HowardHC , BorryP . Changes on the horizon for consumer genomics in the EU . Science346 ( 6207 ), 296 – 298 ( 2014 ).
- Hogarth S , MelzerD . The IVD directive and genetic testing problems and proposals . A briefing Presented to the 20th meeting of Competent Authorities , Lisbon, Portugal , July 2007 .
- Commission (EC) staff working document impact assessment on the revision of the regulatory framework for medical devices ( 2012 ). http://eur-lex.europa.eu/resource.html?uri=cellar:487acc33–213b-4fdf-bdbb-8840209a8807.0001.04/DOC_4&format=PDF .
- Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU. OJ L 117, 5.5.2017 . 176 – 332 ( 2017 ). http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CONSIL:PE_15_2017_INIT&rid=4 .
- Kalokairinou L , HowardHC , BorryP . Current developments in the regulation of direct-to-consumer genetic testing in Europe . Med. Law Int.15 ( 2–3 ), 97 – 123 ( 2015 ).
- Global Harmonization Task Force . “Principles of in vitro diagnostic (IVD) medical devices classification.” ( 2007 ). www.imdrf.org/docs/ghtf/final/sg1/procedural-docs/ghtf-sg1-n045–2008-principles-ivd-medical-devices-classification-080219.pdf .
- BSI . VollebregtE , BosG . “How to prepare for and implement the upcoming IVDR – dos and dont’s.” ( 2016 ). www.bsigroup.com/LocalFiles/EN-AU/ISO%2513485%25Medical%25Devices/WP12_How_to_prepare_for_and_implement_the_upcoming_IVDR___Dos_and_Don___ts(1).pdf .
- Amendments adopted by the European Parliament on 22 October 2013 on the proposal for a regulation of the European Parliament and of the Council on in vitro diagnostic medical devices (COM(2012)0541 – C7–0317/2012 – 2012/0267(COD)) ( 2013 ). http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.C_.2016.208.01.0178.01.ENG&toc=OJ:C:2016:208:TOC .
- Alliance of European Life Sciences Law Firms . “The competence of the European Union to legislate in relation to certain amendments endorsed by the European Parliament in connection with a commission proposal for an in vitro diagnostic device regulation” . www.eshg.org/fileadmin/eshg/documents/IVD/ESHG_Opinion_19_February_2014_final.pdf .
- European Society of Human Genetics . “ESHG position statement on the inclusion of an article on genetic testing in the proposed regulation on in vitro diagnostic devices.” ( 2013 ). www.eshg.org/fileadmin/www.eshg.org/NHGS2013/ESHG_Position_Statement_on_IVD_Regulation.pdf .
- Pormeister K . Informed consent to sensitive personal data processing for the performance of digital consumer contracts on the example of “23andMe” . J. Eur. Consum. Mark. Law.6 ( 1 ), 17 – 23 ( 2017 ).
- Borzekowski DLG , GuanY , SmithKC , ErbyLH , RoterDL . The Angelina effect: immediate reach, grasp, and impact of going public . Genet. Med.16 ( 7 ), 516 – 521 ( 2014 ).