Genomic Health Announces Presentation of New Oncotype DX® Studies Underscoring Unique Value of the Test in Early-Stage Breast Cancer at the 36th Annual CTRC-AACR San Antonio Breast Cancer Symposium

Fourth Head-to-Head Comparison Reveals Important Clinical Distinctions Between Oncotype DX, the Only Test Demonstrated to Predict Chemotherapy Benefit, and Tests Limited to Breast Cancer Prognosis
Conference Marks 10th Anniversary of First Oncotype DX Validation Study, Representing a Decade of Progress in Eliminating 'One-Size-Fits-All' Approach to Breast Cancer Treatment

PR Newswire

REDWOOD CITY, Calif., Dec. 14, 2013 /PRNewswire/ -- Genomic Health, Inc. (GHDX) today announced results from three studies of its Oncotype DX® breast cancer test presented at the 36th Annual CTRC-AACR San Antonio Breast Cancer Symposium (SABCS), reinforcing the unmatched value of the test to patients and physicians worldwide.  Oncotype DX remains the only genomic test to predict chemotherapy benefit, delivering clinically important and practice-changing information not provided by any other test.

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"Ten years ago, the first validation study of the Oncotype DX assay was presented at SABCS, ushering in a new era of personalized breast cancer treatment," said Steven Shak, M.D., executive vice president of research and development, Genomic Health. "Over the last decade, in partnership with many collaborators, we have demonstrated that the rigorous validation of genomic information can transform cancer treatment.  Moving forward we will continue to apply our world-class science to lead the translation of massive amounts of genomic data into practice-changing results for treatment planning from screening and surveillance, through diagnosis, treatment selection and monitoring."

Fourth Head-to-Head Comparison Study to Show Oncotype DX Results Are Different from Tests Limited to Prognosis

A study examining three commercially available genomic tests evaluated if the information they provide is equivalent.  Specifically, results revealed a more than 44 percent discordance with other assays studied when compared to Oncotype DX, highlighting the potential to misclassify and mistreat patients if other assays are used to make a decision regarding chemotherapy treatment.   Oncotype DX is the only test included in treatment guidelines for both prognosis and the prediction of chemotherapy benefit and widely reimbursed by public and private payors for treatment decision making.

"As a clinical investigator and medical oncologist with a practice dedicated to breast cancer, I practice evidence-based medicine and therefore utilize genomic testing to gain an understanding of the breast tumor's individual biology to help guide critical treatment decisions," said Lori J. Goldstein, M.D., Fox Chase Cancer Center, Philadelphia, PA.  "If the question is whether or not to use chemotherapy, the answer is clear. To date, Oncotype DX is the only test that has been appropriately studied and validated to answer the specific question of which ER positive breast cancer patients need chemotherapy in addition to standard-of-care hormonal therapy."

Researchers conducting an analysis of 135 patient samples using Oncotype DX and a 70-gene prognostic test demonstrated that 33 percent of high-risk patients by the 70-gene assay were classified as low risk by the Oncotype DX Recurrence Score, indicating that these patients would likely receive no benefit from chemotherapy.  Further, five percent of the 70-gene assay low-risk patients were classified as high risk by the Oncotype DX test, indicating that they would likely have a significant, potentially life-saving benefit from chemotherapy. 

"Previous studies have demonstrated similar results and suggested that this high level of discordance is related, in part, to the fact that the 70-gene assay was developed in untreated patient populations without consideration of estrogen receptor status or the impact of hormonal treatment which is today's standard of care," said Phil Febbo, M.D., chief medical officer, Genomic Health and former professor of medicine at the University of California, San Francisco.

These findings are consistent with previously reported results at the 2013 ASCO annual meeting (Schneider et al), 2012 San Antonio Breast Cancer Symposium (Poulet et al), 13th St. Gallen International Breast Cancer Conference (Poulet et al) and 2011 ASCO Breast Symposium (Dendaluri et al). 

Two additional studies were presented:

  • "Discordance in hormone receptor (HR) assessment by IHC and RT-PCR in an estrogen receptor (ER) low-positive group (1-10% positive cells): Does accurate assessment of HR status require dual testing?" (Abstract: P3-05-08, Singh B) The results of this study demonstrate the importance of accurate assessment of ER status to ensure appropriate hormonal treatment, and the results highlight the value of the Oncotype DX single gene analysis of ER and PR in providing additional information regarding breast cancer molecular subtyping.
  • "Run-in phase of prospective WSG-ADAPT HR+/HER2- trial demonstrates feasibility of early endocrine sensitivity prediction by Recurrence Score and conventional parameters in clinical routine" (Abstract: P6-05-11, Harbeck N) The run-in phase of the ADAPT HR+/HER2- trial has demonstrated the feasibility of the ADAPT trial design. The main phase of the ADAPT HR+/HER2- trial will evaluate whether adding testing of tumor tissue following short-term hormonal neoadjuvant treatment adds to the treatment planning value already provided by standard Oncotype DX testing of the primary tumor prior to treatment.  

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 September 30, 2013, more than 19,000 physicians in over 70 countries had ordered nearly 400,000 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 our ability to generate similar results in further studies; 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 clinical 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 risks and uncertainties associated with the regulation of our tests; the risks associated with competition; the applicability of clinical study results to actual outcomes; the risks associated with the commercialization of current and future products; the risks and potential delays associated with such studies; 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 Quarterly Report on Form 10-Q for the quarter ended September 30, 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.

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