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Consuming Genomes: Constructing theGenetic Consumer in the United States         Fondazione Giannino Bassetti             ...
How Does it Work?
Currently (May 2011):Began offering itsservices 2007:           193 Reports for $99< 100 Reports for $999   (with annual s...
Health Reports:
Began offering      Currently:services 2007:                    40 Conditions and28 Conditions for   Medications for$2,499...
Companies Claim to Provide Non-        Medical Genetic Testing23andMe: “What we do not and will not do is provide  medical...
A Right to Access Personal Genetic Information23andMe: “Genetic information is a fundamental  element of a person’s body, ...
FDA: DTC Genetic Testing Services Are         a Medical Device
Evaluative Criteria for Genetic Testing• Analytical validity: How accurately and  reliably the test measures the genotype ...
Discrepancies in Disease Risk Reporting
Congress: DTC Genetic Testing is   a Matter of Public Health
Acknowledgments        The Bassetti Foundation   - PieroBassetti & Cristina GrasseniEuropean School for Molecular Medicine...
Consuming Genomes: Constructing the Genetic Consumer in the United States
Consuming Genomes: Constructing the Genetic Consumer in the United States
Consuming Genomes: Constructing the Genetic Consumer in the United States
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Consuming Genomes: Constructing the Genetic Consumer in the United States

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by Margaret Curnutte
European School of Molecular Medicine (SEMM) at the Campus IFOM-IEO (Milano), University of Milano &
Harvard Program on Science, Technology & Society.

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Transcript of "Consuming Genomes: Constructing the Genetic Consumer in the United States"

  1. 1. Consuming Genomes: Constructing theGenetic Consumer in the United States Fondazione Giannino Bassetti 16 May 2011 Margaret Curnutte European School of Molecular Medicine (SEMM) at the Campus IFOM-IEO (Milano), University of Milano & Harvard Program on Science, Technology & Society
  2. 2. How Does it Work?
  3. 3. Currently (May 2011):Began offering itsservices 2007: 193 Reports for $99< 100 Reports for $999 (with annual subscription fee)
  4. 4. Health Reports:
  5. 5. Began offering Currently:services 2007: 40 Conditions and28 Conditions for Medications for$2,499 $1,000
  6. 6. Companies Claim to Provide Non- Medical Genetic Testing23andMe: “What we do not and will not do is provide medical advice to our customers. Though our service delivers personalized data, the information it provides is tailored to genotypes, not to individuals.”Navigenics: “We do not provide medical advice, diagnosis or treatment. You should consult your doctor if you have questions regarding any medical advice, diagnosis or treatment. You should consult your doctor if you have questions regarding any medical condition, before starting any new treatment, and before stopping any treatment that has been prescribed for you.”
  7. 7. A Right to Access Personal Genetic Information23andMe: “Genetic information is a fundamental element of a person’s body, identity and individuality. As such, the rights that they enjoy with regard to financial, medical and other forms of personal information should apply to genetic information as well.”Navigenics: “We believe this is a fundamental right, for people to have access to their own DNA.”
  8. 8. FDA: DTC Genetic Testing Services Are a Medical Device
  9. 9. Evaluative Criteria for Genetic Testing• Analytical validity: How accurately and reliably the test measures the genotype of interest.• Clinical validity: How consistently and accurately the test detects or predicts the intermediate or final outcomes of interest.• Clinical utility: How likely the test is to significantly improve patient outcomes.Centers for Disease Control and Prevention: Public Health GenomicsDepartment of Health and Human Services, Secretary’s Advisory Committee on Genetic Testing.Request for public comment on a proposed classification methodology for determining level of review for genetic tests.Federal Register 2000;65(236):76643-76645.
  10. 10. Discrepancies in Disease Risk Reporting
  11. 11. Congress: DTC Genetic Testing is a Matter of Public Health
  12. 12. Acknowledgments The Bassetti Foundation - PieroBassetti & Cristina GrasseniEuropean School for Molecular Medicine - Giuseppe Testa Program on Science, Technology & Society at the Harvard Kennedy School - Sheila Jasanoff

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