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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

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

  1. 1. Direct-to-Consumer Genetic Information <ul><li>Anne Wojcicki </li></ul><ul><li>Co-Founder </li></ul>
  2. 2. The 23andMe Service <ul><li>Health and traits </li></ul><ul><ul><li>Traits (Lactose tolerance, eye color) </li></ul></ul><ul><ul><li>Disease risks (VTE, macular degeneration) </li></ul></ul><ul><ul><li>Carrier status (Cystic Fibrosis, PKU) </li></ul></ul><ul><ul><li>Drug response (Warfarin, Clopidogrel) </li></ul></ul><ul><li>Ancestry </li></ul><ul><ul><li>Relative Finder </li></ul></ul><ul><ul><li>Ancestry Finder </li></ul></ul><ul><ul><li>Y and Mito Haplogroups </li></ul></ul>Copyright © 2010 23andMe, Inc. All rights reserved.
  3. 3. 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%
  4. 4. Context for Disease Risk John Doe
  5. 5. 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
  6. 6. Research 2.0 Copyright © 2010 23andMe, Inc. All rights reserved.
  7. 7. 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.
  8. 8. “ 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.
  9. 9. <ul><li>23andWe </li></ul>23andMe Proprietary/Confidential Copyright © 2010 23andMe, Inc. All rights reserved.
  10. 10. Year one research results <ul><li>Our internal pipeline runs hundreds of GWAS, nightly to generate updated statistics. </li></ul><ul><li>Recent replications: </li></ul><ul><ul><ul><li>Cholesterol : APOE, APOB, LDLR, PSRC1 </li></ul></ul></ul><ul><ul><li>Psoriasis : HLA </li></ul></ul><ul><ul><li>Gall stones : ABCG8 </li></ul></ul><ul><ul><li>Parkinson's : SNCA and LRRK2 </li></ul></ul><ul><ul><li>Obesity: FTO </li></ul></ul><ul><ul><li>Type 2 diabetes: TCF7L2 </li></ul></ul><ul><ul><li>Lactose intolerance : LCT </li></ul></ul><ul><ul><li>Baldness : AR </li></ul></ul>23andMe Proprietary/Confidential Copyright © 2010 23andMe, Inc. All rights reserved.
  11. 11. Instant Replications (Or Not!)
  12. 12. Challenges for DTC <ul><li>Involve physicians and health care providers </li></ul><ul><li>Standards for analytical and clinical validity, privacy </li></ul><ul><li>Understanding of what real harms and benefits might be </li></ul><ul><li>Framework for reporting genetic information </li></ul><ul><li>Maintaining consumer protection as the industry grows </li></ul>
  13. 13. 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 .

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