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Direct to Consumer Testing - PowerPoint PPT Presentation


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Direct to Consumer Testing. Issues. Types of tests being sold. Diagnostic tests – identify specific conditions Carrier testing - identify those who carry a mutation that if present in two copies causes a genetic disorder.

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Presentation Transcript
types of tests being sold
Types of tests being sold
  • Diagnostic tests – identify specific conditions
  • Carrier testing - identify those who carry a mutation that if present in two copies causes a genetic disorder.
  • Ancestry Testing – ethnic background. For educational purposes but not medical
types of tests being sold1
Types of tests being sold
  • Predisposition testing – looks for genetic risk markers associated with health conditions - looks for markers that do not cause disease but may increase risk – may guide medical decisions and lifestyle choices
  • Medical sensitivity testing – may help with dose adjustment
nutrigenomics
Nutrigenomics
  • Nutrigenomics examines how genetic and cellular processes relate to nutrition and health, including how people with different genetic variants respond to alternative dietary conditions and how diet can switch genes on or off.
  • Personalized diets based on genomics- we are now aware of about 20 genes that that have polymorphisms that appear to confer a significant disadvantage, which may be overcome with dietary modification. There are more but it is these that are being used by companies in the US and elsewhere to sell dietary and lifestyle advice based on gene-testing.
problems
Problems
  • May not have adequate scientific support – limited clinical validation - SNPs vary by which each company analyzes
  • May be easily accessible but no health care professional may be involved in interpretation
  • Even if legitimate may be difficult for layperson to interpret
  • May have implications not only for the person who has the testing but also may affect family members
is oversight needed
Is oversight Needed

It may be Important to regulate both the accessibility and the marketing of genetic

tests

GAO-10-847T

http://www.gao.gov/search?q=GAO-06-977T&Submit=Search

advertising
Advertising
  • Companies market through print, television. and internet advertising
  • Increases public awareness but does this reach the appropriate individuals i.e. those at risk?
  • Does it accurately disclose the limitations of the testing results provided?
questions
Questions
  • What will the testing tell the individual?
  • How could this affect insurance?
  • Will the information be kept private?
  • Will the results be misleading?
  • Will consumers be deceived about their health?
  • Should consumers have access to these test kits even with some guidance?
what should consumers consider
What Should Consumers Consider
  • Is the lab CLIA certified?
  • Is discussion with a genetic counselor available? Is this included in the price?
  • Will the information be useful – can I act on it to improve my health?
advantages
Advantages
  • Less expensive
  • Privacy – Genetic Information Nondiscrimination Act (GINA) – prevents discrimination so consumers can purchase health insurance and will not increase premiums, will not affect employment
  • Public awareness
  • Education and empowerment – personalized medicine
disadvantages
Disadvantages
  • Misinterpretation – false security, or overemphasis leading to stress and anxiety
  • Poor Decision Making –due to misinterpretation of results
  • Inaccurate or Unsubstantiated Results –may not be based on peer reviewed material and may not have been replicated
  • Poor Regulation – can receive different results from different companies, interpretation may be very different as knowledge grows
  • Lack of Counseling
  • Privacy-encryption, bankruptcy
disadvantages1
Disadvantages
  • GINA provides no protection for other types of insurance – life, disability, long term care
  • Other family members may be affected if the results are not kept private
where can i find dtc services
Where Can I Find DTC Services
  • http://www.dnapolicy.org/resources/DTCcompanieslist.pdf
conclusions tests can be interesting and may be educational but
ConclusionsTests can be interesting and may be educational BUT
  • What is their medical value?
  • Is the data secure?
  • DTC sale is unregulated, uncertain and undefined