Ashley Gould of 23andMe at FDA Public Meeting on LDTs, July 20, 2010

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23andMe General Counsel Ashley Could Addresses FDA/CDRH Public Meeting on Oversight of Laboratory Developed Tests (LDTs), July, 20, 2010

Education & Outreach Ashley Gould General Counsel

How can individuals use genetic information? Whose responsibility is it to ensure physicians can use the information provided to them?

New associations every week Copyright © 2010 23andMe, Inc. All rights reserved.

Education is Critical Copyright © 2010 23andMe, Inc. All rights reserved. “ We believe genetic research tools can and should be used to give us a deeper understanding of the role genes play in our individual lives. By tapping into the advances in DNA analysis and offering education, tools and expertise we want to help others take a bold, informed step in self-knowledge.”

Genetics 101 Copyright © 2010 23andMe, Inc. All rights reserved.

23andMe provides context and steps for what to do next Ask your doctor about screening tests Estimate your risk Keep your weight in check Learn your family medical history Connect with relevant groups Talk with a genetic counselor John Doe Copyright © 2010 23andMe, Inc. All rights reserved.

Traits: Bitter Taste John Doe Copyright © 2010 23andMe, Inc. All rights reserved.

The 23andMe Blog: The Spittoon Copyright © 2010 23andMe, Inc. All rights reserved.

Outreach Free 23andMe service to hundreds of physicians Significantly reduced pricing for academics In 2010, launched pilot project in partnership with top-ranked medical school to utilize 23andMe data in human genetics classes In July 2010 hosted policy forum aimed at discussing technical, policy, ethical and social issues related to realization of personalized medicine—included panel on integration of genetics into the clinic Copyright © 2010 23andMe, Inc. All rights reserved.

Education Behavior Change Copyright © 2010 23andMe, Inc. All rights reserved. Only 1 in 10 individuals are screened for colon cancer Of cancers that affect both men and women, colorectal cancers is the second leading cancer killer in the United States. If everybody aged 50 or older had regular screening tests as many as 60% of deaths from colorectal cancer could be prevented. John Doe - source: Center for Disease Control website

“ Individuals who present to health care providers with online genetics information may be among the most motivated to take steps toward healthier lifestyles . These motives might be leveraged by health care providers to promote positive health outcomes .” - McBride C.M., Alford S.H., Reid R.J., Larson E.B., Baxevanis A.D., Brody L. “Characteristics of users of online personalized genomic risk assessments: implications for physician-patient interactions.” Genet Med , 11(8):582-7. 2009.

. Conclusion Shared responsibility to foster environment for integration of genetic testing data into physician practice among industry, government and medical community Copyright © 2010 23andMe, Inc. All rights reserved.

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1. Education & Outreach Ashley Gould General Counsel

2. How can individuals use genetic information? Whose responsibility is it to ensure physicians can use the information provided to them?

4. Education is Critical Copyright © 2010 23andMe, Inc. All rights reserved. “ We believe genetic research tools can and should be used to give us a deeper understanding of the role genes play in our individual lives. By tapping into the advances in DNA analysis and offering education, tools and expertise we want to help others take a bold, informed step in self-knowledge.”

6. 23andMe provides context and steps for what to do next Ask your doctor about screening tests Estimate your risk Keep your weight in check Learn your family medical history Connect with relevant groups Talk with a genetic counselor John Doe Copyright © 2010 23andMe, Inc. All rights reserved.

9. Outreach Free 23andMe service to hundreds of physicians Significantly reduced pricing for academics In 2010, launched pilot project in partnership with top-ranked medical school to utilize 23andMe data in human genetics classes In July 2010 hosted policy forum aimed at discussing technical, policy, ethical and social issues related to realization of personalized medicine—included panel on integration of genetics into the clinic Copyright © 2010 23andMe, Inc. All rights reserved.

10. Education Behavior Change Copyright © 2010 23andMe, Inc. All rights reserved. Only 1 in 10 individuals are screened for colon cancer Of cancers that affect both men and women, colorectal cancers is the second leading cancer killer in the United States. If everybody aged 50 or older had regular screening tests as many as 60% of deaths from colorectal cancer could be prevented. John Doe - source: Center for Disease Control website

11. “ Individuals who present to health care providers with online genetics information may be among the most motivated to take steps toward healthier lifestyles . These motives might be leveraged by health care providers to promote positive health outcomes .” - McBride C.M., Alford S.H., Reid R.J., Larson E.B., Baxevanis A.D., Brody L. “Characteristics of users of online personalized genomic risk assessments: implications for physician-patient interactions.” Genet Med , 11(8):582-7. 2009.

12. . Conclusion Shared responsibility to foster environment for integration of genetic testing data into physician practice among industry, government and medical community Copyright © 2010 23andMe, Inc. All rights reserved.

Ashley Gould of 23andMe at FDA Public Meeting on LDTs, July 20, 2010

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