Oncotype DX® Presentations at ASCO in Breast and Prostate Cancer Reinforce Genomic Health's Leadership in Optimizing Cancer Treatment

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June 1, 2015 at 8:00 AM EDT

Oncotype DX® Presentations at ASCO in Breast and Prostate Cancer Reinforce Genomic Health's Leadership in Optimizing Cancer Treatment

REDWOOD CITY, Calif., June 1, 2015 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced results from multiple Oncotype DX® studies presented at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting. The presentations reinforce the robustness of the Oncotype DX tests across invasive breast cancer, ductal carcinoma in situ (DCIS) and prostate cancer, which, to date, have helped guide treatment decisions for more than half a million patients worldwide.

Two DCIS Studies Reinforce Independent Value of Oncotype DX DCIS Score™

A secondary analysis from the second large validation study conducted by the Sunnybrook Health Sciences Centre in Ontario evaluated the DCIS Score™ result as a predictor of local recurrence in 718 patients treated with breast-conserving surgery (BCS) alone with any surgical margin width. The analysis showed that, in all patients regardless of margin status, the DCIS Score result was significantly associated with the 10-year risk of local recurrence (p < 0.001). These results underscore the value of the DCIS Score result in providing unique tumor biology information that is not readily apparent by margin status alone.

A separate secondary analysis evaluated the correlation between the DCIS Score result and clinicopathologic features, such as age, tumor size, nuclear grade and multifocality. The results from 571 women with DCIS who had BCS alone and clear margins showed that the DCIS Score result quantifies risk of local recurrence independent of clinicopathologic features, reconfirming previous findings from the ECOG-ACRIN Cancer Research Group clinical validation study.

"To accurately assess a patient's individual risk for cancer returning, we now have a tool like Oncotype DX that can provide important biological information beyond the traditional measures that had been available to physicians before," said Michael Alvarado, M.D., breast cancer surgeon, the University of California, San Francisco Helen Diller Family Comprehensive Cancer Center. "Multiple studies and my own personal experience with this test clearly demonstrate that Oncotype DX provides important information about the risk of local recurrence based on the biology of the tumor beyond what is apparent by traditional measures such as age, size, or grade."

Baseline Characteristics from NCI-Sponsored Trial Assigning IndividuaLized Options for Treatment (Rx), or TAILORx, Confirmed Consistency of Oncotype DX Recurrence Score® Results Across Race and Ethnicity

An analysis of the study population enrolled in the TAILORx trial examined baseline patient characteristics, including race, ethnicity and body mass index (BMI), as well as their Recurrence Score results. The results showed no significant difference in Recurrence Score result distribution among Caucasian, African-American, Hispanic or Asian patients despite the clinical differences between those groups of patients. These data are consistent with prior studies that have shown that the Recurrence Score result provides information beyond that provided by clinical and pathologic features.

Coordinated by the ECOG-ACRIN Cancer Research Group, TAILORx is designed to evaluate the effect of chemotherapy in women with mid-range Recurrence Score results, as previous studies have confirmed chemotherapy benefit for those with high Recurrence Score disease and minimal, if any, benefit for patients who have low Recurrence Score disease. TAILORx is one of the largest breast cancer adjuvant treatment trials, with more than 10,000 patients enrolled from 1,500 sites in the United States, Canada, Ireland, Peru and Australia. Investigator reporting of the TAILORx long-term outcome results for patients in the mid-range group is anticipated in 2016-2017.

Study of Oncotype DX Genomic Prostate Score Underscores Value of Analyzing Gene Groups in Prostate Cancer

In prostate cancer, a study of 3,500 patient tumor samples processed in Genomic Health's commercial laboratory highlighted the importance of utilizing multiple biological pathways to predict tumor behavior. In this study, each of the four gene groups incorporated in the Oncotype DX Genomic Prostate Score (GPS) showed large variations in expression and meaningfully affected the GPS results, underscoring the importance of analyzing distinct genes across multiple pathways to provide more accurate risk assessment than currently available clinical risk factors and help improve treatment decision making.

"These scientific presentations reinforce the Company's successful approach to understanding risk assessment and, more importantly, emphasize our commitment to enabling physicians to individualize treatment plans for their patients," said Phil Febbo, M.D., chief medical officer, Genomic Health. "The data we presented at ASCO further demonstrate the clinical actionability that our Oncotype DX tests provide, allowing physicians and their patients to make more informed cancer treatment decisions."

About Oncotype DX®
The Oncotype DX® portfolio of breast, colon and prostate cancer tests applies advanced genomic science to reveal the unique biology of a tumor in order to optimize cancer treatment decisions. The Oncotype DX prostate cancer test identifies which clinically low risk patients are eligible for active surveillance, as well as those who may benefit from immediate treatment by predicting disease aggressiveness.  With half a million patients tested in more than 80 countries, the Oncotype DX testing has redefined personalized medicine by making genomics a critical part of cancer diagnosis and treatment. To learn more about the Oncotype DX prostate cancer test, visit:   www.OncotypeDX.com or www.myprostatecancertreatment.org.

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 diagnosis to treatment selection and monitoring. 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: @GenomicHealthFacebookYouTube and LinkedIn.

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the benefits of the test to physicians, patients and payors. 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 ability of test results to change treatment decisions; the risks and uncertainties associated with the regulation of the company's tests; the results of clinical studies; the applicability of clinical study results to actual outcomes; 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 of competition; unanticipated costs or delays in research and development efforts; 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 year ended March 31, 2015. 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

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SOURCE Genomic Health, Inc.

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