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

1. Consuming Genomes: Constructing the
Genetic 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

3. How Does it Work?

4. Currently (May 2011):
Began offering its
services 2007: 193 Reports for $99
< 100 Reports for $999 (with annual subscription fee)

5. Health Reports:

6. Began offering Currently:
services 2007:
40 Conditions and
28 Conditions for Medications for
$2,499 $1,000

8. Companies Claim to Provide Non-
Medical Genetic Testing
23andMe: “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.”

9. A Right to Access Personal Genetic Information
23andMe: “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.”

10. FDA: DTC Genetic Testing Services Are
a Medical Device

11. 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 Genomics
Department 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.

12. Discrepancies in Disease Risk Reporting

13. Congress: DTC Genetic Testing is
a Matter of Public Health

15. Acknowledgments
The Bassetti Foundation
- PieroBassetti & Cristina Grasseni
European School for Molecular Medicine
- Giuseppe Testa
Program on Science, Technology &
Society at the Harvard Kennedy School
- Sheila Jasanoff