Genomic Health Announces Presentation of Oncotype DX® Studies Reinforcing Value of Tests in Guiding Treatment for Multiple Cancers Four Studies Presented at the European Cancer Congress, Following NICE's Recommendation for Using Oncotype DX Test to Guide Chemotherapy Decisions in Early-stage Breast Cancer Patients

Company Leads Next Generation Sequencing (NGS) Symposium Highlighting Its Leadership in International Dialog on Integration and Translation of Big Data in Cancer

AMSTERDAM and REDWOOD CITY, Calif., Oct. 1, 2013 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced results from four studies highlighting the value of its Oncotype DX® tests for optimizing treatment for patients with breast and colon cancer.  Three new decision impact studies - including the company's first international decision impact study in colon cancer and additional evidence for the Oncotype DX breast cancer test's significant impact on breast cancer treatment decisions in the United Kingdom (UK) - were among data presented at the European Cancer Congress 2013, taking place September 27-October 1 in Amsterdam.  The results were presented on the heels of the recent National Institute for Health and Care Excellence (NICE) guidance announcement that recommended the use of Oncotype DX "as an option to help clinicians decide whether to prescribe chemotherapy in people with early breast cancer."     

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"By continuing to invest in research and clinical utility studies, we are able to provide actionable genomic information to facilitate more informed cancer treatment decisions," said Christer Svedman, director, medical affairs in Europe, Genomic Health.  "The growing body of evidence and the consistency of results for both the invasive breast and colon cancer tests clearly establish them as valuable tools for patients and physicians worldwide."

Further Evidence Confirms Oncotype DX Results Significantly Impacts Breast and Colon Cancer Treatment Decisions

  • A prospective multi-center study of 148 early-stage, estrogen receptor-positive breast patients from the United Kingdom confirmed that use of the Oncotype DX breast cancer test was associated with a significant change in treatment decisions and an overall 23 percent net reduction in chemotherapy use.  Findings from this second decision impact study in the UK are consistent with those previously reported from the UK and 17 other Oncotype DX decision impact studies from Europe, Australia, Japan, Mexico and North America.  The results underscore the value of using the test in the UK where NICE recently recommended Oncotype DX. Further, updated St. Gallen International guidelines have, for the second time, recognized the Oncotype DX breast cancer test as the only multi-gene test to predict chemotherapy benefit in patients with early-stage endocrine sensitive invasive breast cancer. (Abstract 2068: "A prospective multi-centre study of the impact of Oncotype DX on adjuvant treatment decisions in patients in the UK with estrogen receptor positive early breast cancer," Sept. 30, 14:00-16:30 CEST, Hall 4)

"Utilizing genomic medicine to optimize cancer treatment is becoming an increasingly important focus for physicians worldwide," said Jeremy Braybrooke, M.D., University Hospitals Bristol in the United Kingdom. "With the recent NICE recommendation and continued research demonstrating Oncotype DX's clinical relevance in early-stage breast cancer, we can use this test to help more UK patients benefit from individualized treatment."

The results of two colon cancer studies from Israel and the Unites States highlight the value of individualized recurrence risk assessment to enable physicians to identify high-risk patients who can experience a greater potential benefit from chemotherapy, as well as patients with a low risk of recurrence who can be spared unnecessary treatment.

  • A prospective study of 269 colon cancer patients with stage IIa, mismatch-repair proficient (MMR-P) disease in Israel showed that the Oncotype DX colon cancer test changed treatment decisions in 38 percent of patients.  For patients whose treatment recommendations changed, treatment intensity decreased for 28 percent of patients (from chemotherapy to observation or from oxaliplatin-containing to non-oxaliplatin containing regimens) and increased for 10 percent of patients (from observation to any chemotherapy or from non-oxaliplatin containing to oxaliplatin-containing treatment).  (Abstract 2382: "Impact of the 12-gene colon cancer recurrence score assay on clinical decision-making for adjuvant therapy in stage II colon cancer patients in Israel," Sept. 29, 14:00-16:30 CEST, Hall 4)
  • This study, conducted in collaboration with the Mayo Clinic Cancer Research Consortium, analyzed treatment decisions for 141 colon cancer patients with stage IIa, MMR-P disease across 17 sites demonstrating that the use of the Oncotype DX colon cancer test changed treatment decisions 45 percent of the time and led to an overall reduction in chemotherapy use. For patients whose treatment recommendations changed, treatment intensity decreased for 33 percent of patients (from chemotherapy to observation or from oxaliplatin-containing to non-oxaliplatin containing regimens) and increased for 11 percent of patients (from observation to any chemotherapy or from non-oxaliplatin containing to oxaliplatin-containing treatment).  The decrease in physician recommendations for adjuvant chemotherapy resulted in direct medical care costs savings of $1,683 per patient. (Abstract 2184: "Prospective multi-center study of the impact of Oncotype DX Colon Cancer Assay results on treatment recommendations in stage II colon cancer patients," Sept. 30, 11:30- 12:30 CEST, RAI Auditorium)

New Data Suggest There is Similar Underlying Biology in Colon and Rectal Cancer

As part of the company's commitment to studying the use of Oncotype DX in different types and stages of cancer, researchers also reported results from a clinical validation study of the colon cancer test in stage II and stage III rectal cancer patients treated with surgery alone, which demonstrated similarities in colon and rectal cancer biology.

  • The study, conducted by the Department of Surgery at the Leiden University Medical Centre, evaluated the Recurrence Score® results and recurrence risk in rectal cancer patients from the landmark Dutch Total Mesorectal Excision (TME) trial.  All 297 patients analyzed from the trial had stage II or III rectal cancer and were treated with surgery alone.  In this population of rectal cancer patients, the Recurrence Score predicted recurrence risk (p=0.011), with particularly strong results in stage II.   The test was also shown to predict the risk of distant recurrence and rectal cancer specific survival (p=0.030 and p=0.007 respectively).  These results suggest that the Oncotype DX colon cancer test may help identify high-risk rectal cancer patients who could benefit from and low-risk patients who may forego aggressive therapies.  (Abstract: Validation of the 12-gene colon cancer Recurrence Score assay as a predictor of recurrence risk in stage II and III rectal cancer patients," Sept. 28, 13:45-15:55 CEST, Hall 7.1)

In addition to the data presentations during the European Cancer Congress 2013, Genomic Health also led a satellite symposium titled, "A View to Next Generation Sequencing in Cancer." Samuel Levy, Ph.D., chief scientific officer at Genomic Health, joined a panel discussion with leading international genomics and oncology experts to discuss the impact of next generation sequencing (NGS) on current and future cancer care from medical, scientific and health-economic perspectives.  Levy is the senior author of the first published diploid genome sequence of a human, and had a distinguished career in genomics prior to joining Genomic Health, including his tenure at Scripps and the J. Craig Venter Institute. 

"In harnessing the power of NGS technology, our scientists can analyze a wealth of genomic data to discover how cancer genomes are able to modify gene expression via mutation strategies," said Levy.  "As a leader in cancer genomics, our goal with the symposium was to continue the international dialogue on the promise of how sequence-based genomics will enable 'big data' to impact future clinical development in cancer."

About Genomic Health

Genomic Health, Inc. (NASDAQ: GHDX) is the world's leading provider of genomic-based diagnostic tests that address the overtreatment 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 throughout the cancer patient's journey, from screening and surveillance, to diagnosis, to 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 June 30, 2013, more than 19,000 physicians in over 70 countries had ordered more than 375,000 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 belief that the OncotypeDX is unique in its ability to predict chemotherapy benefit in early stage breast cancer;; the company's belief that its OncotypeDX tests, including its colon and breast  cancer tests are  cost effective and can reduce the cost of treatment in various health systems around the world; the company's belief that it has the opportunity to advance the quality of cancer treatment decisions;  the potential impact of  the recommendation by NICE of OncotypeDX Breast Cancer Test for use in England and Wales on  greater international utilization of OncotypeDX; the clinical utility of our next generation sequencing capabilities; our ability to develop whole transcriptome and/or genome expression analysis for routine clinical study; the belief that whole genome expression may accelerate clinical or biomarker discovery; our ability to develop, validate or commercialize advanced diagnostics based upon such genome expression data; the timing of such studies and results; the applicability of study results to actual outcomes; the ability of the company's tests to impact clinical practice; and the focus and attributes of the company's product pipeline. 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: risks related to the success of the company's breast, colon and prostate cancer tests; 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; the company's ability to develop and commercialize new tests; the company's ability to use next generation sequencing methods to discover and develop novel  biomarkers; unanticipated costs or delays in research and development efforts;  the company's ability to successfully commercialize its tests outside of the United States; the results of clinical studies; the applicability of clinical study results to actual outcomes; 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 June 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, OncotypeDX, 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.

SOURCE Genomic Health, Inc.



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