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Genomic Health Inc. Message Board

  • terry_amln terry_amln Jul 9, 2013 3:16 PM Flag

    Note to investors from CEO Brad Cole

    June 27, 2013
    As the field of molecular diagnostics advances and new companies offering genomic-based
    breast cancer tests emerge, a number of you have approached us with questions about how
    these efforts compare to Oncotype DX®
    and our work at Genomic Health. We’d like to take this
    opportunity to highlight the important distinctions that should be taken into consideration as you
    evaluate these companies and their products.
    The Oncotype DX Recurrence Score®
    was developed to answer the specific question of which
    estrogen receptor positive (ER+) breast cancer patients need chemotherapy in addition to
    hormonal therapy. To validate it for this specific purpose, Genomic Health and its collaborators
    obtained practice-changing results from landmark clinical studies that included patients
    randomized to treatment (so that both prognosis and prediction could be obtained) and followed
    for long term outcomes. To date, it is the only test validated to predict who benefits from
    chemotherapy, and the only test included in all major breast cancer guidelines (ASCO,NCCN)
    for treatment decision making. As a result, it has been broadly adopted by the physician
    community, widely reimbursed in the United States, and used to guide treatment in more than
    350,000 breast cancer patients around the world.

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    • part 2
      Additionally, recent data presented at major medical meetings showed clinically meaningful
      differences between patient results generated by the Oncotype DX breast cancer test and the
      Mammaprint test, which unlike Oncotype DX was developed using a largely untreated patient
      population that did not reflect the established standard of care of hormone therapy for patients
      with estrogen receptor positive disease. Specifically, these results revealed that patients
      stratified as high-risk by Mammaprint with high ER expression may lead physicians to
      inappropriately offer treatment with chemotherapy.
      We realize there is a lot of information in the market right now that can lead to confusion, and
      we encourage you to ask the following questions when talking to companies who claim to offer
      tests similar to Oncotype DX.
      • What specific clinical question was the test developed to answer and is it relevant
      to current practice?
      • Were multiple randomized studies, including treated and untreated patients,
      conducted to validate and reproduce the test’s ability to answer this question?
      • What comprises test volume – is it commercial or research use?
      • Are they getting paid routinely by private payors without appeal?
      • For tests in kit form, like the one Nanostring is developing, what measures are
      taken to ensure high, reproducible quality at local labs?
      • Have they conducted prospectively designed, randomized trials with long term
      clinical outcomes (i.e., 10 years or longer)?
      • What is the pipeline opportunity and how is the company investing in it to drive
      long-term growth?
      We would be happy to schedule a call to discuss this information in more detail.
      Brad Cole
      Chief Operating Officer

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