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Genomic Health Announces Presentation of Three Oncotype DX® Studies in Breast and Colon Cancers at the 2012 European Society for Medical Oncology Congress

REDWOOD CITY, California and VIENNA, Austria, September 28, 2012 /PRNewswire/ --

Large Prospective Study Validates Use of the Oncotype DX test in Stage II and Stage III Colon Cancer and Identifies Genes that May Indicate Effectiveness of Oxaliplatin

Results from Europe and Mexico-Based Studies Reconfirm the Impact of the Oncotype DX test on Guiding Treatment Decisions in Invasive Breast Cancer Patients

Genomic Health, Inc. (Nasdaq: GHDX) today announced the presentation of data that support expanded use of the Oncotype DX® tests in optimising treatment decisions for breast and colon patients at various stages of disease. The new data confirm the ability of the Oncotype DX colon cancer test to predict recurrence risk in stage II and stage III colon cancer patients, and exploratory analyses have identified 16 genes strongly associated with oxaliplatin treatment benefit.  Additionally, two studies reconfirm the clinical utility of the Oncotype DX breast cancer test in treatment decision making in women with early-stage invasive breast cancer.  

The study results are being presented at the 2012 European Society for Medical Oncology (ESMO) Congress taking place September 28-October 2 in Vienna, Austria.  

"Personalised medicine requires accurate assessment of the patient's individual tumor biology," said Christer Svedman, director, medical affairs in Europe, Genomic Health.  "The new data add to a large body of evidence demonstrating that the Oncotype DX test is an important tool enabling more informed treatment decisions in early-stage breast and colon cancer patients worldwide."

Colon Cancer: Findings Provide Third Successful Prospectively Designed Study of Oncotype DX Colon Cancer Test in Patients with Stage II Disease, First Validation Study in Patients with Stage III Disease; Identify Genes that May Predict Patient Benefit from Oxaliplatin

A large, independent validation study involving 892 patients demonstrates that the Oncotype DX Colon Cancer Recurrence Score® results predict risk of recurrence, disease-free survival and overall survival in stage II and stage III colon cancer patients receiving adjuvant chemotherapy in the landmark randomised NSABP C-07 clinical trial.  The study also indicates that risk assessment with the Recurrence Score assay enables better discrimination of the expected absolute benefit of adding oxaliplatin to adjuvant 5FU chemotherapy.  

Additionally, an exploratory component of this study, researchers analysed 735 genes and identified 16 genes as being predictive of oxaliplatin benefit, narrowing down specific genes and pathways associated with sensitivity or resistance to oxaliplatin when added to adjuvant 5-fluorouracil chemotherapy.  The company will utilize these positive results to develop an algorithm and a standardised quantitative laboratory process with the plan to initiate a validation study in 2013.

"The Recurrence Score has shown us that there is a continuous biology in colon cancer versus a high or low ranking, and understanding where a patient falls on that continuum is going to help both stage II and stage III colon cancer patients make more informed decisions regarding adjuvant therapy," said principal investigator Michael O'Connell, M.D., associate chairman of The National Surgical Adjuvant Breast and Bowel Project (NSABP).  "The discovery of new genes holds promise for the development of a genomic test that would benefit a broader Stage II and Stage III patient population by providing better understanding of oxaliplatin benefit."

The poster and discussion presentation titled, "The 12-gene Colon Cancer Recurrence Score (RS) Predicts Recurrence in Stage II and III Colon cancer Patients Treated with 5FU/LV (FU) and 5FU/LV + Oxaliplatin (FU+Ox): Validation in NSABP C-07" (Abstract #523PD), will take place on Sept. 29, 1-2 p.m., Hall C.

Breast Cancer: Growing Evidence Continues to Reinforce the Impact of the Oncotype DX test on Treatment Decisions in Patients with Early-Stage Invasive Breast Cancer

"Genomic testing reveals the patient's individual tumor biology, enabling more informed treatment decisions," said Simon Holt, MA, MB, BChir, FRCS, Lead Breast Surgeon, Hywel Dda Health Board, Wales, United Kingdom.  "Oncotype DX is the only clinically  validated multi-gene assay that has proved predictive of chemotherapy treatment benefit and new data reinforces the important role this test can play in ultimately enhancing the quality of care for breast cancer patients."

  • A meta-analysis of four prospective studies from the United Kingdom, Germany, France, and Spain including 565 patients with node-negative, estrogen receptor-positive breast cancer, showed that based on knowledge of the Recurrence Score result, 48 percent of patients initially recommended chemotherapy were advised to omit chemotherapy and 18 percent of patient who were initially advised hormonal therapy alone were advised to add chemotherapy.  These results further demonstrate that use of the Oncotype DX test is associated with a significant change in treatment decisions and an overall reduction in chemotherapy use in the studied European countries regardless of different local treatment traditions.

The poster and discussion titled, "Meta-analysis of Prospective European Studies Assessing the Impact of Using the 21-Gene Recurrence Score Assay on Clinical Decision Making in Women with ER-positive, HER2-negative Early Stage Breast Cancer" (Abstract #252PD), will take place on Sept. 29, 1-2 p.m., Hall G.

  • Results of the first Oncotype DX breast cancer test treatment decision impact study from Mexico showed that in 96 patients who used the test in a public hospital setting, the knowledge of the Recurrence Score result changed physicians' treatment recommendations for 32 percent of early-stage invasive breast cancer patients.  This study demonstrated that, based on the Recurrence Score result, 46 percent of patients initially recommended chemotherapy were advised to omit chemotherapy and use hormonal therapy alone, and 16 percent of patients initially recommended hormonal therapy alone were advised to add chemotherapy to their treatment regimen. These results suggest that use of the Oncotype DX test in the Mexican public health system has an impact on adjuvant treatment recommendations and may reduce the need and use of chemotherapy.

The poster presentation titled, "A study of the impact of the 21-gene breast cancer assay on the use of adjuvant chemotherapy in women with breast cancer in a Mexican public hospital" (Abstract #289P), will take place on Oct. 1, 1-2 p.m., Hall XL.

About Genomic Health

Genomic Health, Inc. (NASDAQ: GHDX) is a global health company that provides actionable genomic information to personalize genomic health 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 June 30, 2012, more than 10,000 physicians in over 65 countries had ordered more than 295,000 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, http://www.GenomicHealth.com. To learn more about Oncotype DX tests, visit: http://www.OncotypeDX.com and http://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 tests to optimize cancer treatment in patients with breast and colon cancer; the ability of the Oncotype DX Breast Cancer test Recurrence Score to impact treatment decisions in a clinical setting; the ability of the Oncotype DX Colon Cancer test to individualize cancer treatment decisions stage II and III colon cancer patients treated with Oxaliplatin; the potential of the Company's tests to change medical practice ; the applicability of study results to clinical practice; the timing and results of future studies; the focus of the company's product pipeline, the ability of the company to develop additional tests in the future , and the ability of any potential tests the company may develop to optimize cancer treatment. 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 clinical study results to actual outcomes; the risks and uncertainties associated with possible additional regulation of our tests both in the United States and abroad; the risks associated with the commercialization of current and future products; the risks associated with competition; the risks and potential delays associated with such studies; 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 June 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.

Contacts:
Investors:
Dean Schorno
Genomic Health
+1-650-569-2281
[email protected]

Media:
Victoria Steiner
Genomic Health
+1-415-370-5804
[email protected]

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