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Aaron DeLong, Jim Dugan, Zana Percy, & Maggie Sfiligoj

Aaron DeLong, Jim Dugan, Zana Percy, & Maggie Sfiligoj. Congress has charged the FDA with the important task of ensuring that products marketed to the public are both safe and effective, giving the FDA considerable authority to regulate genetic tests . 1.

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Aaron DeLong, Jim Dugan, Zana Percy, & Maggie Sfiligoj

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  1. Aaron DeLong, Jim Dugan, Zana Percy, & Maggie Sfiligoj

  2. Congress has charged the FDA with the important task of ensuring that products marketed to the public are both safe and effective, giving the FDA considerable authority to regulate genetic tests.1 1Jennifer K. Wagner, Understanding FDA Regulation of DTC Genetic Tests within the Context of Administrative Law, The American Journal of Human Genetics, Volume 87, Issue 4, 8 October 2010, Pages 451-456, ISSN 0002-9297, 10.1016/j.ajhg.2010.09.003.

  3. Availability of DTC Testing • DTC genetic tests will be available to anyone who wishes to learn more about their own genes • Will continue to develop & improve • Cheaper • Faster • More accurate

  4. Ordering DTC Testing • Criteria: • 18 years or older • Informed medical decision by an adult • Avoiding unnecessary emotional trauma • Sworn Identity Statement • Ensures that the person reading the informed consent is the person whose sample will undergo testing • Samples must be saliva or blood to decrease analysis of uninformed citizens who did not choose to undergo genetic testing

  5. Required Materials • Basic information about the test • The science behind the genetic test • May decrease misconceptions and increase consumer awareness

  6. Required Materials (cont.) • Selective Results • Consumers can pick and choose which results they want to see • Information about the disease & its outcomes • The consumer should know if the lab is CLIA certified • Clinical laboratories and DTC testing labs are very similar • Reassure consumers of the test’s accuracy

  7. Results • Format of test results is up to each DTC company • All results must be organized, informative, and easy to comprehend • Selective review of the results • Before or after testing • Harbor the consumer from unwanted knowledge

  8. Informed Consent • Consumer needs to know the risks, benefits and limitations of obtaining results • Risk and limitations can not be understated • Prior to testing • Consumer should know what diseases/conditions are being tested • Possible outcomes of disease/condition • Option for pre and post-test counseling

  9. Interpretation of Results • Genetic counselor or a genetic professional should be involved in the interpretation of the results • Companies should provide consumers with a information in order to get in contact with a professional before testing is done

  10. Interpretation (cont.) • May involve pre and post-test counseling • Family health history analysis • Consumer reactions, concerns, and expectations will vary based on the test • Dry ear wax vs. Alzheimer’s Disease • Genetic testing for sports or other skills

  11. Citations McBride, Colleen M., and Alan E. Guttmacher. "Commentary: Trailblazing a Research Agenda at the Interface of Pediatrics and Genomic Discovery--a Commentary on the Psychological Aspects of Genomics and Child Health." Journal of pediatric psychology 34.6 (2009): 662-4. Print. Howard, Heidi Carmen, Denise Avard, and Pascal Borry. "Are the Kids really all Right? Direct-to-Consumer Genetic Testing in Children: Are Company Policies Clashing with Professional Norms?" European Journal of Human Genetics 19.11 (2011): 1122-6. Print. Samuel, G.N., F.C. Jordens, and I. Kerridge. “Direct-to-Consumer Personal Genome Testing: Ethical and Regulatory Issues that Arise from Wanting to ‘Know’ Your DNA”. Internal Medicine Journal 40.3 (2010):220-4. Print Hogarth, Stuart, Gail Javitt, and David. Annual Review of Genomics and Human Genetics Melzer. "The Current Landscape for Direct-to-Consumer Genetic Testing: Legal, Ethical, and Policy Issues." Annual Review of Genomics and Human Genetics (2008). Donna A. Messner (2011): Informed choice in direct-to-consumer genetic testing for Alzheimer and other diseases: lessons from two cases, New Genetics and Society, 30:1, 59-72.http://www.tandfonline.com/doi/abs/10.1080/14636778.2011.552300 United States. Cong. House. Subcommittee on Oversight and Investigations. Direct-to-Consumer Genetic Testing and the Consequences to the Public. By Jeffrey Shuren, MD. 111th Cong., 2nd sess. H. Rept. FDA.gov, 22 July 2010. Web. 1 Dec 2012. http://fda.gov/NewsEvents/Testimony/ucm21995.htm Geransar, Rose, and Edna Einsiedel. "Evaluating Online Direct-to-Consumer Marketing of Genetic Tests: Informed Choices or Buyers Beware?" Genetic Testing 12.1 (2008): 13-23. Print.

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