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Genomic Health Announces Presentation of New Data Further Supporting Use of Oncotype DX® in Europe

March 19, 2014

Data Presented at 9th European Breast Cancer (EBCC-9) Symposium Highlights Comprehensive Body of Clinical Evidence for Oncotype DX

REDWOOD CITY, Calif., March 19, 2014 /PRNewswire/ — Genomic Health, Inc. (Nasdaq: GHDX) today announced the presentation of multiple Oncotype DX® breast cancer studies at the 9(th) European Breast Cancer Conference (EBCC-9), which takes place March 19-21 in Glasgow, Scotland, United Kingdom. New data will include an independently conducted physician survey that underscores the need for broader availability of standard predictive genomic testing, like Oncotype DX, to help better inform chemotherapy treatment decisions in early-stage breast cancer patients in Europe. Additional studies showcasing the unsurpassed volume and consistency of clinical validation, clinical utility and health-economics evidence supporting the use of Oncotype DX will also be presented at the meeting.

“Over the past decade, we have generated more clinical evidence than any company in the world around genomics in breast cancer, and the unmatched body of support specifically for the use of the Oncotype DX breast cancer test is highlighted in the EBCC presentations,” said Christer Svedman, M.D., senior director of medical affairs in Europe, Genomic Health. “We will continue to apply world-class science to lead the translation of massive amounts of genomic data into practice-changing results to achieve better standards in treatment planning in breast cancer worldwide.”

Physician Survey Reveals Substantial Differences in Chemotherapy Treatment Recommendations, Underscoring the Need for Broader Genomic Testing in Europe to Enable More Informed Decisions

Estrogen receptor (ER) positive breast cancer patients receive hormonal treatment after surgery, but sometimes chemotherapy is also needed. The Multidisciplinary Application of Genomics in Clinical Practice (MAGIC) survey[i] aims to identify the role of classic pathology criteria that clinicians use in daily practice when recommending adjuvant chemotherapy in ER positive patients. This online survey analyzed responses from 911 physicians representing 52 countries. The results reveal substantial heterogeneity in the criteria used to determine chemotherapy use, suggesting a compelling need for broader use of objective, predictive genomic tests which can help physicians and patients make more informed treatment decisions.

“The survey shows that patients are treated differently depending on where they live in Europe, despite having the same tumor characteristics,” said Matti Aapro, M.D., the lead investigator of the MAGIC survey and dean of the Multidisciplinary Oncology Institute, Genolier, Switzerland. “A genomic tool provides information beyond traditional measures and can lead to more informed treatment decisions. This is reflected in international clinical practice guidelines, including St. Gallen and ASCO, which both incorporate the genomic tool called Oncotype DX,” said Aapro.

“Patient attributes considered for decision-making with regard to adjuvant chemotherapy in early stage HR+, HER2- breast cancer patients: Results of the Multidisciplinary Application of Genomics in Clinical Practice (MAGIC) survey,” (Abstract P015) will be presented on March 19, 8:00-16:30 GMT, Adjuvant Drug Therapy Session, Poster Area.

Roadmap of Oncotype DX Clinical Evidence Showcases Test’s Unsurpassed Validity

Genomic tests are developed and validated through a variety of approaches, resulting in different levels of evidence supporting their ability to guide treatment decisions. With the rapidly evolving dissemination of genomic assays and their incorporation into clinical practice, it is important to have not only rigorous development, analytical and clinical validation, but also to demonstrate clinical utility and cost effectiveness in order to secure reimbursement coverage and, ultimately, inclusion in guidelines.

An analysis of oncology guidelines, peer-reviewed articles and public presentations on the Oncotype DX breast cancer test–involving 16 studies in 1,766 patients–clearly reinforces its robust clinical validation for prognosis and prediction of chemotherapy benefit, as well as its clinical utility in changing treatment recommendation in approximately 30 percent of patients. Additionally, this analysis across multiple markets reconfirms that the test is cost-effective.

“The 21-gene breast cancer assay: A roadmap of clinical evidence,” (Abstract P117) will be presented on March 21, 8:00-14:00 GMT, Pathology and Molecular Pathology Session, Poster Area.

In addition to the studies highlighted above, additional Oncotype DX data presented includes:

    --  The run-in-phase of the prospective WSG-ADAPT trial confirmed trial
        design estimates of Recurrence Score(®) results and reduction in
        markers of proliferation following endocrine induction therapy,
        indicating that the multi-center prospective ADAPT concept combining
        static and dynamic biomarker assessment for individualized therapy
        decisions in early-stage breast cancer is feasible. (Abstract P005:
        "Early proliferation response stratified by recurrence score
        demonstrates distinct efficacy of different endocrine therapies in the
        prospective WSG-ADAPT HR+/HER2- trial run-in phase," March 20,
        15:30-16:30 GMT, Systemic Therapy Session, Lomond Auditorium)
    --  An analysis of the distribution of Recurrence Score results in patients
        with ER positive breast cancer who have been considered for neoadjuvant
        chemotherapy showed that there was a wide range of results in the
        patients selected for chemotherapy, primarily due to large tumor size.
        The researchers concluded that Oncotype DX may be of value in selecting
        patients for neoadjuvant chemotherapy trials. (Abstract P038: "Should
        tumour size be reconsidered as a criterion for neoadjuvant
        chemotherapy?" March 19, 8:00-16:30 GMT, Adjuvant Drug Therapy Session,
        Poster Area)

About Genomic Health

Genomic Health, Inc. (NASDAQ: GHDX) is the world’s leading provider of genomic-based diagnostic tests that address both the overtreatment and optimal treatment of early stage cancer, one of the greatest issues in healthcare today. The company is applying its world-class scientific and commercial expertise and infrastructure to lead the translation of massive amounts of genomic data into clinically-actionable results for treatment planning throughout the cancer patient’s journey, from screening and surveillance, through diagnosis, treatment selection and monitoring. Genomic Health’s lead product, the Oncotype DX® breast cancer test, has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer and has been shown to predict the likelihood of recurrence in ductal carcinoma in situ (DCIS). In addition to this widely adopted test, Genomic Health provides the Oncotype DX colon cancer test, the first multi-gene expression test developed for the assessment of risk of recurrence in patients with stage II and stage III disease, and the Oncotype DX prostate cancer test, which predicts disease aggressiveness in men with low risk disease. As of December 31, 2013, more than 19,000 physicians in over 70 countries had ordered approximately 420,000 Oncotype DX tests. The company is based in Redwood City, California with European headquarters in Geneva, Switzerland. For more information, please visit, www.GenomicHealth.com and follow the company on Twitter: @GenomicHealth. To learn more about OncotypeDX tests, visit: www.OncotypeDX.com, www.mybreastcancertreatment.org and www.myprostatecancertreatment.org.

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the demand for our Oncotype DX Breast Cancer test in Europe; the advantages of the Oncotype DX Breast Cancer test over other tests in guiding the use of chemotherapy in early stage breast cancer treatment; the applicability of study results to actual outcomes; the ability of the company’s tests to impact clinical practice ; the ability of the company to develop and commercialize additional tests in the future; the attributes of the company’s product pipeline; and the scope, success or results of clinical trials and the timing of such activities. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and reported results should not be considered as an indication of future performance.

These risks and uncertainties include, but are not limited to: the applicability of study results to clinical practice; the timing and results of future studies or clinical trials; the focus and attributes of the company’s product pipeline; the ability of the company to develop additional tests in the future; and the ability of the company’s currently offered tests, including its breast cancer test, and any potential tests the company may develop to optimize cancer treatment; the company’s ability to increase usage of its tests; the risk that the company may not obtain or maintain sufficient levels of reimbursement, domestically or abroad, for its existing tests and any future tests it may develop; the risks and uncertainties associated with regulation of the company’s tests by the FDA and other regulatory organizations; the company’s ability to compete against third parties; and the other risks set forth in the company’s filings with the Securities and Exchange Commission, including the risks set forth in the company’s Annual Report on Form 10-K for the period ended December 31, 2013. These forward- looking statements speak only as of the date hereof. Genomic Health disclaims any obligation to update these forward-looking statements.

NOTE: The Genomic Health logo, Oncotype, Oncotype DX, Recurrence Score, and DCIS Score are trademarks or registered trademarks of Genomic Health, Inc. All other trademarks and service marks are the property of their respective owners.


[i] Facilitated by TRM Oncology with input from leading European physicians and sponsored by Genomic Health

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SOURCE Genomic Health, Inc.


Source: PR Newswire



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