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    About Genomic Health, Inc.: Genomic Health Is Committed To Prolonging and Enhancing The Lives of Patients With Cancer

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    fdablog
    Genomic Health is a company located in Redwood City, California that is committed to prolonging and enhancing the lives of cancer patients through personalized medicine. It has over 450 employees and operates a 20,000 square foot clinical lab. Genomic Health provides the Oncotype DX breast cancer test, which has been extensively validated in over 4,000 patients and 13 clinical trials to analyze the genomic characteristics of tumors and provide individualized treatment plans. The Oncotype DX test is widely used by over 8,000 physicians in over 55 countries and has reimbursement coverage in the US and other countries.

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    About Genomic Health, Inc.: Genomic Health Is Committed To Prolonging and Enhancing The Lives of Patients With Cancer

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    fdablog
    29 views7 pages
    Genomic Health is a company located in Redwood City, California that is committed to prolonging and enhancing the lives of cancer patients through personalized medicine. It has over 450 employees and operates a 20,000 square foot clinical lab. Genomic Health provides the Oncotype DX breast cancer test, which has been extensively validated in over 4,000 patients and 13 clinical trials to analyze the genomic characteristics of tumors and provide individualized treatment plans. The Oncotype DX test is widely used by over 8,000 physicians in over 55 countries and has reimbursement coverage in the US and other countries.

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    FDA-2010-N-0274-0039.1

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    Genomic Health is a company located in Redwood City, California that is committed to prolonging and enhancing the lives of cancer patients through personalized medicine. It has over 450 employees and operates a 20,000 square foot clinical lab. Genomic Health provides the Oncotype DX breast cancer test, which has been extensively validated in over 4,000 patients and 13 clinical trials to analyze the genomic characteristics of tumors and provide individualized treatment plans. The Oncotype DX test is widely used by over 8,000 physicians in over 55 countries and has reimbursement coverage in the US and other countries.

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    Attribution Non-Commercial (BY-NC)
    Download as PPTX, PDF, TXT or read online from Scribd
    Download as pptx, pdf, or txt
    29 views7 pages

    About Genomic Health, Inc.: Genomic Health Is Committed To Prolonging and Enhancing The Lives of Patients With Cancer

    Uploaded by

    fdablog
    Genomic Health is a company located in Redwood City, California that is committed to prolonging and enhancing the lives of cancer patients through personalized medicine. It has over 450 employees and operates a 20,000 square foot clinical lab. Genomic Health provides the Oncotype DX breast cancer test, which has been extensively validated in over 4,000 patients and 13 clinical trials to analyze the genomic characteristics of tumors and provide individualized treatment plans. The Oncotype DX test is widely used by over 8,000 physicians in over 55 countries and has reimbursement coverage in the US and other countries.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PPTX, PDF, TXT or read online from Scribd
    Download as pptx, pdf, or txt
    of 7

    About Genomic Health, Inc.

    Genomic Health is committed to


    prolonging and enhancing
    the lives of patients with cancer

    • Incorporated August 22, 2000


    – Currently 450+ employees
    • Located in Redwood City,
    California
    – All tests ordered by physicians
    – 20,000 sq. ft. clinical lab with CLIA
    certification and College of American
    Pathology (CAP) accreditation
    • Recognized Leader in
    advancement of Personalized
    Medicine
    – Member of 21st Century Medicine
    Coalition and American Clinical
    Laboratory Association

    1
    The Facts…
    U.S. Healthcare Costs Are Soaring

    Source: Burrill & Company 2009 Biotech Report

    2
    "One-Size-Fits-All" Medicine is Not Sustainable,
    Does Not Deliver Optimal Results

    Source: Burrill & Company 2009 Biotech Report

    3
    Example of Treatment of a Common Cancer Today

    Hormone Receptor Positive, Early Stage Breast Cancer


    • Over 400,000 patients worldwide are diagnosed each year
    – Most of these patients are offered chemotherapy, knowing that few
    benefit
    • Only 4 of 100 women with node negative breast cancer benefit
    from chemotherapy
    • Toxicity is experienced by all
    • Direct costs of adding chemotherapy is approximately $31,000 per
    patient

    Genomic Health provides individualized treatment


    planning for patients based on the genomics of their
    tumors.
    4
    Extensive Clinical Validation
    More than 4,000 Patients Studied in 13 Trials

    Study Type No. Pts Nodal Status


    Providence Exploratory 136 Neg

    Rush* Exploratory 78 Pos

    NSABP B-20 Exploratory 233 Neg

    NSABP B-14* Prospective 668 Neg

    MD Anderson* Prospective 149 Neg

    Kaiser Permanente* Prospective Case-Control 790 Cases/Controls Neg

    NSABP B-14 Prospective Placebo vs Tam 645 Neg

    Milan* Exploratory 89 Neg/Pos

    NSABP B-20* Prospective Tam vs Tam+Chemo 651 Neg

    ECOG 2197* Exploratory and Prospective 776 Neg/Pos

    SWOG 8814* Prospective Tam vs Tam+Chemo 367 Pos

    ATAC* Prospective Tam vs AI 1231 Neg/Pos

    Japan BCRG Study* Prospective 280 Neg/Pos

    *Published studies

    5
    Oncotype DX Breast Cancer Test Today

    • Oncotype DX Extensively Reviewed


    – Oncotype DX Included in Published Breast Cancer Clinical Practice
    Guidelines
    – American Society of Clinical Oncology (ASCO) Panel (Harris et al, J ClinOncol 2007)
    – National Comprehensive Cancer Network (NCCN) (http://www.nccn.org)

    – Oncotype positively reviewed by NY’s CLEP and BlueCross/BlueShield’s


    Technology Evaluation Center
    • Widespread Physician Usage and Adoption
    – 150,000+ Oncotype DX breast test results delivered (all performed in
    Redwood City, CA)
    – >8,000 physicians have ordered the test
    – >55 countries using Oncotype DX breast cancer test
    • Reimbursement in the U.S. and other countries
    – Wide coverage in the U.S.
    – Coverage for all Medicare patients ; Coverage >90% of privately insured lives

    – Growing coverage in other countries


    – Canada, Israel, Greece and Germany

    6 6
    Innovation is Dependent Upon Reasonable
    and Predictable Regulatory Oversight
    • Clear, Predictable, Non Duplicative Oversight
    – Recognition of existing CLIA and State oversight of laboratory operations

    • Additional Oversight of Tests Already in Use


    – Must not result in disruption of current care

    • Product Review Standards


    – Consistent with evolving standards among experts in the field as
    demonstrated by professional guidelines based upon evidence reviews
    – Evidence requirements that appropriately lead to cleared intended use
    claims that reflect the real use of these tests, for example, as an aid in
    treatment selection

    7 7

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