Genomic Health Announces Positive Results from Large Study of Oncotype DX® to Quantify Risk of Loco-Regional Recurrence in Node-positive Breast Cancer Patients and Acceptance of Oncotype DX DCIS Validation Study for Publication Findings suggest value of Oncotype DX in tailoring radiation therapy treatment for select node-positive patients treated with hormonal therapy and chemotherapy

Oncotype DX DCIS validation study accepted by peer-reviewed journal for publication in coming months

REDWOOD CITY, Calif., March 13, 2013 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced positive results of a large study that demonstrates the Oncotype DX® Recurrence Score® result to be a robust predictor of loco-regional recurrence (LRR) in node-positive (N+), estrogen receptor (ER) positive patients treated with adjuvant hormonal therapy and chemotherapy.  This study, titled "Prognostic impact of the 21-gene Recurrence Score (RS) on loco-regional recurrence (LRR) of node-positive, ER-positive breast cancer patients (pts) treated with adjuvant chemotherapy: Results from NSABP B-28" was recently presented at the 2013 Society of Surgical Oncology Annual Cancer Symposium in National Harbor, Maryland.

"Gaining a better understanding of the patient's individual risk of loco-regional recurrence can assist physicians in determining the most appropriate comprehensive treatment plan," said Terry Mamounas, M.D., Medical Director, Comprehensive Breast  Program, MD Anderson Cancer Center Orlando, and member of the National Surgical Adjuvant Breast and Bowel Project (NSABP) board.  "These new data show that for ER-positive lymph node-positive breast cancer patients, Oncotype DX not only helps identify those who will have excellent outcomes with adjuvant chemo-endocrine therapy, as previously reported, but it can also be useful for radiation treatment decision making."

This study analyzed tumor samples from 1,065 hormone receptor-positive, node-positive breast cancer patients who were treated with hormonal therapy and anthracycline containing chemotherapy as part of the NSABP B-28 trial.  After a median follow-up of 11.2 years, 80 patients had local (68 percent) or regional (32 percent) recurrence. The 10-year cumulative incidence of loco-regional recurrence was 3.3 percent  for patients with a low Recurrence Score result, 7.2 percent for those with an intermediate Recurrence Score result, and 12.3 percent  for those with high Recurrence Score result (p<0.001), demonstrating that the Recurrence Score was significantly associated with the risk of loco-regional recurrence.  These new findings may have clinical implications in node-positive patients treated with adjuvant chemo-endocrine therapy as they consider post-mastectomy chest wall or regional nodal radiotherapy, and post-lumpectomy regional nodal radiotherapy.

"Previous studies have shown the value of Oncotype DX in predicting chemotherapy benefit in both node-negative and node-positive breast cancer. Based on the results presented by Dr. Mamounas, we now have evidence suggesting the value of the Oncotype DX result in tailoring the intensity and extent of radiation in breast cancer patients with node-positive disease," said Steven Shak, M.D., chief medical officer and executive vice president for research and development at Genomic Health.  "This study, combined with an upcoming publication in DCIS, demonstrates our continued efforts in helping physicians and breast cancer patients answer important treatment decision questions about the intensity of their radiation therapy." 

The parent NSABP B-28 trial was funded by the National Cancer Institute with additional support from Bristol Myers Squibb. The study evaluating the prognostic impact of the 21-gene Recurrence Score on loco-regional recurrence was funded through a grant from the Susan G. Komen for the Cure Foundation.

About Genomic Health

Genomic Health, Inc. (NASDAQ: GHDX) is a global healthcare company that provides actionable genomic information to personalize cancer treatment decisions.  The company'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.  As of December 31, 2012, more than 10,000 physicians in over 70 countries had ordered approximately 335,000 Oncotype DX tests.  Genomic Health has a robust pipeline focused on developing tests to optimize the treatment of prostate and renal cell cancers, as well as additional treatment decisions in breast and colon cancers.  The company is based in Redwood City, California with European headquarters in Geneva, Switzerland.  For more information, please visit, www.GenomicHealth.com. To learn more about Oncotype DX tests, visit: www.OncotypeDX.com and www.mybreastcancertreatment.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 ability  of the  company's Oncotype DX test to predict loco regional recurrence in node positive breast cancer patients and the potential ability of the  test to be used in  radiation treatment decisions; the applicability of clinical study results to actual outcomes; the scope, success or results of clinical trials and the timing of such activities; the ability of the test to impact clinical practice; the expectations and timing for the publication of the DCIS validation study; the ability of the company to develop additional tests in the future; the attributes and focus of the company's product pipeline; the potential economic benefits associated with the company's tests; and the demand for the company's tests. 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 results of clinical studies; the applicability of clinical study results to actual outcomes; the risks and potential delays associated with such studies;  the risks and uncertainties associated with publication of  the DCIS validation study;  the risks and uncertainties associated with possible additional regulation of the company's tests both in the United States and abroad;; the risks associated with 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 quarter ended September 30, 2012. 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.  


SOURCE Genomic Health, Inc.



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