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Anne Wojcicki of 23andMe at FDA Public Meeting on LDTs, July 20, 2010
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Anne Wojcicki of 23andMe at FDA Public Meeting on LDTs, July 20, 2010

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23andMe President and Co-Founder Anne Wojcicki Addresses FDA/CDRH Public Meeting on Oversight of Laboratory Developed Tests (LDTs), July, 20, 2010

23andMe President and Co-Founder Anne Wojcicki Addresses FDA/CDRH Public Meeting on Oversight of Laboratory Developed Tests (LDTs), July, 20, 2010

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  • We offer a variety of health information.
  • 3 rd point: physician is necessary to the process info. We do not argue with this but we think there are other ways as well. We are providing tools to minimize the chance of both of these outcomes. We give our data in context. As you can see here, when a person gets their data, they are comparing the average person’s risk against their own risk. We also provide extensive information about the condition and we give them steps on what to do next; these steps include encouraging consumers to discuss their results with their physician and to speak with a genetic counselor. Besides this, we have a myriad of tools to help educate consumers about their genetic information. My colleague will discuss our education in a later session. Reveal is also beginning a trial now to study the topic of how people handle the information with and without physicians as intermediaries.
  • 3 rd point: physician is necessary to the process info. We do not argue with this but we think there are other ways as well. We are providing tools to minimize the chance of both of these outcomes. We give our data in context. As you can see here, when a person gets their data, they are comparing the average person’s risk against their own risk. We also provide extensive information about the condition and we give them steps on what to do next; these steps include encouraging consumers to discuss their results with their physician and to speak with a genetic counselor. Besides this, we have a myriad of tools to help educate consumers about their genetic information. My colleague will discuss our education in a later session. Reveal is also beginning a trial now to study the topic of how people handle the information with and without physicians as intermediaries.
  • We will be listening today, have been thinking about this and will be sharing Ideas with FDA Friday
  • DTC Industry needs clear and rational regulatory oversight framework to thrive and contribute meaningfully to personalized medicine

Anne Wojcicki of 23andMe at FDA Public Meeting on LDTs, July 20, 2010 Anne Wojcicki of 23andMe at FDA Public Meeting on LDTs, July 20, 2010 Presentation Transcript

  • Direct-to-Consumer Genetic Information
    • Anne Wojcicki
    • Co-Founder
  • The 23andMe Service
    • Health and traits
      • Traits (Lactose tolerance, eye color)
      • Disease risks (VTE, macular degeneration)
      • Carrier status (Cystic Fibrosis, PKU)
      • Drug response (Warfarin, Clopidogrel)
    • Ancestry
      • Relative Finder
      • Ancestry Finder
      • Y and Mito Haplogroups
    Copyright © 2010 23andMe, Inc. All rights reserved.
  • Who learns what? Venous thromboembolism: F5 or F2 carrier 8.2% Cystic fibrosis carrier 4% Substantially lower odds of responding to IFN-alpha 3.5% Greatly reduced Clopidogrel efficacy 3.1% Alpha-1 antitrypsin deficiency carrier 2.9% Sensorineural hearing loss carrier 1.8% Substantially increased Warfarin dose 0.5% Parkinson’s disease: LRRK2 carrier 0.5% Tay-Sachs carrier 0.4% Sickle cell trait 0.3% BRCA1 or BRCA2 carrier 0.2%
  • Context for Disease Risk John Doe
  • 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
  • Research 2.0 Copyright © 2010 23andMe, Inc. All rights reserved.
  • The Parkinson’s Project: July 2010 World's largest database of individuals with LRRK2 genotype ~4000 participants Over 75% have completed the Parkinson’s surveys 23andMe Proprietary/Confidential Copyright © 2010 23andMe, Inc. All rights reserved.
  • “ As for this site, it makes me feel like I am not alone, there is someone out there I can talk to, even if it is just to compare symptoms. Even though I have become actively involved in 2 PD groups, these conversations really help. Thank you to everyone who takes the time to read and reply.” 23andMe Proprietary/Confidential Copyright © 2010 23andMe, Inc. All rights reserved.
    • 23andWe
    23andMe Proprietary/Confidential Copyright © 2010 23andMe, Inc. All rights reserved.
  • Year one research results
    • Our internal pipeline runs hundreds of GWAS, nightly to generate updated statistics.
    • Recent replications:
        • Cholesterol : APOE, APOB, LDLR, PSRC1
      • Psoriasis : HLA
      • Gall stones : ABCG8
      • Parkinson's : SNCA and LRRK2
      • Obesity: FTO
      • Type 2 diabetes: TCF7L2
      • Lactose intolerance : LCT
      • Baldness : AR
    23andMe Proprietary/Confidential Copyright © 2010 23andMe, Inc. All rights reserved.
  • Instant Replications (Or Not!)
  • Challenges for DTC
    • Involve physicians and health care providers
    • Standards for analytical and clinical validity, privacy
    • Understanding of what real harms and benefits might be
    • Framework for reporting genetic information
    • Maintaining consumer protection as the industry grows
  • Conclusion DTC genetic industry—like the entire genetic industry— needs a clear and rational regulatory oversight framework that also allows companies to contribute meaningfully to personalized medicine and improved health care .