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Genomic HealthOncotype DX<br />E25 Project <br />MuthuAlagappan<br />Vaishnav Aradhyula<br />
Pitch Outline<br />Review of Science<br /><ul><li>Human Genome Project
Gene Expression and RT-qPCR</li></ul>Introduction to Oncotype DX<br />Innovations<br /><ul><li>21-gene panel including HER...
Pitch Outline<br />Review of Science<br /><ul><li>Human Genome Project
Gene Expression and RT-qPCR</li></ul>Introduction to Oncotype DX<br />Innovations<br /><ul><li>21-gene panel including HER...
A Review of Personalized Medicine<br />Knowledge of a patient’s genome can inform treatment<br />Certain genomic traits pr...
 Gene Expression<br />Gene expression is the conversion of information encoded by a gene into a functional gene product (u...
Measuring Gene Expression<br />RT-PCR + qPCR (or RT-qPCR)<br />Generate cDNA template from mRNA using reverse transcriptio...
Pitch Outline<br />Review of Science<br /><ul><li>Human Genome Project
Gene Expression and RT-qPCR</li></ul>Introduction to Oncotype DX<br />Innovations<br /><ul><li>21-gene panel including HER...
Oncotype DX – An Overview<br />Developed by Genomic Health, a life science company based in Redwood City and founded in 20...
Oncotype DX— Background<br />Incidence<br />270,000 cases of breast cancer per year in the U.S.<br />1.15 million per year...
Clinical Need for Oncotype DX<br />Physicians require a diagnostic tool that:<br />Quantitatively states the chances of re...
Pitch Outline<br />Review of Science<br /><ul><li>Human Genome Project
Gene Expression and RT-qPCR</li></ul>Introduction to Oncotype DX<br />Innovations<br /><ul><li>21-gene panel including HER...
How Oncotype DX Was Developed<br />250 candidate genes (from ~25,000 genes in the human genome) identified from literature...
The 21 Genes<br />From Paik et. al<br />
HER2<br />HER2 (human epidermal growth factor receptor 2) is a tyrosine kinasereceptor protein that is over-expressed in a...
Oncotype DX in Practice<br />Submit tissue sample<br />Genomic Health sends back RS score and data<br />Doctor and Patient...
Pitch Outline<br />Review of Science<br /><ul><li>Human Genome Project
Gene Expression and RT-qPCR</li></ul>Introduction to Oncotype DX<br />Innovations<br /><ul><li>21-gene panel including HER...
FDA Process<br />Food and Drug administration used to evaluate and approve new medical devices, drugs, and diagnostics tes...
FDA Approval Phases<br />
Advantages of CLIA<br />CLIA is the Clinical Laboratory Improvement Amendment<br />Objective: to guarantee the accuracy an...
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Engineering 25 bonus powerpoint oncotype dx (2)

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Transcript of "Engineering 25 bonus powerpoint oncotype dx (2)"

  1. 1. Genomic HealthOncotype DX<br />E25 Project <br />MuthuAlagappan<br />Vaishnav Aradhyula<br />
  2. 2. Pitch Outline<br />Review of Science<br /><ul><li>Human Genome Project
  3. 3. Gene Expression and RT-qPCR</li></ul>Introduction to Oncotype DX<br />Innovations<br /><ul><li>21-gene panel including HER2</li></ul>CLIA vs. FDA<br />Future Pipeline<br />
  4. 4. Pitch Outline<br />Review of Science<br /><ul><li>Human Genome Project
  5. 5. Gene Expression and RT-qPCR</li></ul>Introduction to Oncotype DX<br />Innovations<br /><ul><li>21-gene panel including HER2</li></ul>CLIA vs. FDA<br />Future Pipeline<br />
  6. 6. A Review of Personalized Medicine<br />Knowledge of a patient’s genome can inform treatment<br />Certain genomic traits predict the patient’s susceptibility to disease<br />Specific treatments can be tailored to fit the patient<br />From E25 Lecture 8<br />
  7. 7. Gene Expression<br />Gene expression is the conversion of information encoded by a gene into a functional gene product (usually proteins)”<br />Certain genes (and thus certain proteins) are often found to be overexpressed in several types of cancer <br />E.g. HER2 overexpression is linked to breast cancer<br />Thus, measuring levels of gene expression is a essential technique in understanding cancer<br />
  8. 8. Measuring Gene Expression<br />RT-PCR + qPCR (or RT-qPCR)<br />Generate cDNA template from mRNA using reverse transcription<br />
  9. 9. Pitch Outline<br />Review of Science<br /><ul><li>Human Genome Project
  10. 10. Gene Expression and RT-qPCR</li></ul>Introduction to Oncotype DX<br />Innovations<br /><ul><li>21-gene panel including HER2</li></ul>CLIA vs. FDA<br />Future Pipeline<br />
  11. 11. Oncotype DX – An Overview<br />Developed by Genomic Health, a life science company based in Redwood City and founded in 2000<br />Oncotype DX is a diagnostic test for breast cancer<br />Analyzes 21 genes from a breast cancer tumor to determine the likelihood of recurrence and the effectiveness of chemotherapy<br />
  12. 12. Oncotype DX— Background<br />Incidence<br />270,000 cases of breast cancer per year in the U.S.<br />1.15 million per year worldwide<br />Treatment<br />Previous treatments based mainly on understanding of chemical pathways<br />Tamoxifen and chemotherapy proven to be reasonably effective in clinical trials <br />However, chemotherapy overused because not possible to determine the risk of recurrence<br />
  13. 13. Clinical Need for Oncotype DX<br />Physicians require a diagnostic tool that:<br />Quantitatively states the chances of recurrence (as opposed to “high” or “low”)<br />Known as prognostic significance<br />Indicates whether the patient will significantly benefit from chemotherapy<br />Known as predictive significance<br />Important because of chemotherapy’s severe side effectss<br />
  14. 14. Pitch Outline<br />Review of Science<br /><ul><li>Human Genome Project
  15. 15. Gene Expression and RT-qPCR</li></ul>Introduction to Oncotype DX<br />Innovations<br /><ul><li>21-gene panel including HER2</li></ul>CLIA vs. FDA<br />Future Pipeline<br />
  16. 16. How Oncotype DX Was Developed<br />250 candidate genes (from ~25,000 genes in the human genome) identified from literature and previous studies<br />The gene expression of these genes relative to control genes measured against recurrence in 477-patient sample<br />16 genes identified <br />21 gene test (16 cancer-related genes and 5 reference genes) developed<br />Algorithm developed to assign Recurrence Score (0 to 100) based on expression of the 21 genes<br />
  17. 17. The 21 Genes<br />From Paik et. al<br />
  18. 18. HER2<br />HER2 (human epidermal growth factor receptor 2) is a tyrosine kinasereceptor protein that is over-expressed in aggressive forms of breast cancer<br />Location: Long arm of chromosome #17<br />Mechanism: HER2 and HER3 dimerize on cell membrane. Growth factor binds and causes cell proliferation.<br />Significance: 30% of breast cancers have an over-expression of HER2. Also linked to ovarian and stomach cancer.<br />Drug herceptin can reduce the expression of HER2<br />Impact: <br />patients with HER2 expression have decreased survival rates<br />HER2 over-expression is more likely to signal tumor reoccurrence after surgery (75% chance vs 86%) <br />Used as 1 of 21 genes on our genetic panel (out of a potential 25,000 genes)<br />
  19. 19. Oncotype DX in Practice<br />Submit tissue sample<br />Genomic Health sends back RS score and data<br />Doctor and Patient make informed decision<br />
  20. 20. Pitch Outline<br />Review of Science<br /><ul><li>Human Genome Project
  21. 21. Gene Expression and RT-qPCR</li></ul>Introduction to Oncotype DX<br />Innovations<br /><ul><li>21-gene panel including HER2</li></ul>CLIA vs. FDA<br />Future Pipeline<br />
  22. 22. FDA Process<br />Food and Drug administration used to evaluate and approve new medical devices, drugs, and diagnostics test<br />1976: FDA passes amendments which allowed “homebrew in vitro diagnostics” to come to market without FDA approval (because all testing would be done by the company within their own laboratory)<br />FDA approval requires 3 phases of clinical trials<br />1988: Companies that do in vitro diagnostic testing in their laboratory now need to get CLIA approval.<br />
  23. 23. FDA Approval Phases<br />
  24. 24. Advantages of CLIA<br />CLIA is the Clinical Laboratory Improvement Amendment<br />Objective: to guarantee the accuracy and reliability of diagnostic testing of patient tissue performed by laboratories<br />CLIA does not require any clinical trials. Instead, it only requires an application, evaluation, and payment.<br />Advantage: CLIA can save Genomic Health millions of dollars and years of time from clinical trials<br />Downside: Clinical trials are sometimes necessary to convince physicians of the advantages of the diagnostic<br />
  25. 25. Validation of Oncotype DX<br />Does a high recurrence score actually correlate to recurrence?<br />Test Oncotype DX against large sample to ensure that it works<br />Data taken from<br />National Surgical Adjuvant Breast and Bowel Project (NSABP) trials B-14 and B-20<br />Trials assessed effectiveness of Tamoxifen<br />2892 patients randomly assigned to Tamoxifen or placebo<br />Statistical Analysis of recurrence score versus actual recurrence reveals that the Oncotype DX assay is a very good predictive tool<br />
  26. 26. Recurrence Score is an Excellent Predictive Tool<br />From Paik et. al<br />
  27. 27. Pitch Outline<br />Review of Science<br /><ul><li>Human Genome Project
  28. 28. Gene Expression and RT-qPCR</li></ul>Introduction to Oncotype DX<br />Innovations<br /><ul><li>21-gene panel including HER2</li></ul>CLIA vs. FDA<br />Future Pipeline<br />
  29. 29. Genomic Health Pipeline<br />Genomic Health other products<br />Colon cancer<br />Prostrate cancer<br />Renal cancer<br />
  30. 30. Bibliography<br />Paik, S et. al. A Multigene Assay to Predict Recurrence of Tamoxifen-Treated, Node-Negative Breast Cancer. N Engl J Med. 351;27. 30 Dec 2004<br />http://ecog.dfci.harvard.edu/general/gendocs/tailorx_oncodxfact.pdf<br />http://www.oncotypedx.com/en-US/Breast/HealthcareProfessional/Overview.aspx<br />Sparano, JA and Paik, S. Development of the 21-Gene Assay and Its Application in Clinical Practice and Clinical Trials. J ClinOncol. 2008; 26:721-728. <br />http://en.wikipedia.org/wiki/Gene_expression<br />http://www.genomichealth.com/en-US/Pipeline/NextGeneration.aspx<br />http://www6.appliedbiosystems.com/support/tutorials/pdf/rtpcr_vs_tradpcr.pdf<br />http://www.genomichealth.com/en-US/Company.aspx<br />
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