Genomic Health Announces Results from Fourteen Studies Emphasizing Belief of Physicians around the World in the Value of Oncotype DX

REDWOOD CITY, Calif., Dec. 12, 2011 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced the presentation of results from fourteen studies at the 2011 CTRC-AACR San Antonio Breast Cancer Symposium (SABCS) reinforcing the impact of the Oncotype DX® breast cancer test on changing treatment decisions and demonstrating its cost effectiveness across multiple health care systems.  Additionally, data continues to reconfirm the accuracy, precision, reproducibility and consistency of the Recurrence Score® (RS) results in patients with early-stage breast cancer.  Presentations included ten international studies from the United Kingdom, Germany, France, Ireland, Australia, Venezuela, and a review including data from Israel, Canada, Hungary, Japan, and Singapore.

"The results presented at this world-leading breast cancer conference reflect our commitment to demonstrate and deliver the clinical utility and cost effectiveness of the Oncotype DX Breast Cancer test to physicians and patients around the world," said Christer Svedman, director, medical affairs in Europe, Genomic Health.  "Oncotype DX consistently changes treatment recommendations in approximately 30 percent of cases and is found to be cost effective in multiple countries in Europe, Asia, North America and Israel.  We are committed to bringing these benefits into clinical practice worldwide."

Oncotype DX Changes Physician Treatment Recommendations in Australia, Germany and the UK by about 30 Percent

Results based on decision impact studies that include a total of 658 patients from the United Kingdom, Germany, and Australia confirm data from previous similar studies reinforcing that knowledge of a patient's Recurrence Score changes about 30 percent of adjuvant chemotherapy treatment decisions. Furthermore, data indicate that the Oncotype DX RS result has a similar impact on treatment decision making in node-positive patients as it does in node-negative patients.

"By providing prognostic and predictive information beyond traditional markers, Oncotype DX gives me and my patients greater confidence in selecting the most appropriate treatment option," said Simon Holt, MA, MB, BChir, FRCS, Lead Breast Surgeon, Hywel Dda NHS Trust Board, Wales, UK.  "The results of this study reinforce that the use of Oncotype DX may result in better patient care by enabling physicians to tailor treatment recommendations and by providing added reassurance to patients that they have made the right decision about chemotherapy based on their individual tumor biology."

Multiple Health Economic Analyses Demonstrate Cost Effectiveness of Oncotype DX across Nine Healthcare Systems in Europe, Asia, Israel and North America

"Based on this consistent health economic data, combined with the growing body of evidence illustrating the clinical value of Oncotype DX, I hope more patients around the world can get access to the test to help determine whether they should receive adjuvant chemotherapy treatment," said Paolo Pronzato, MD, The National Institute for Cancer Research, Genova, Italy. 

"Our research shows there is 99.6 percent probability that Oncotype DX would be cost-effective in the United Kingdom, versus current clinical practice," said Holt.  "Oncotype DX allows us to use our health funds more effectively while sparing patients from unnecessary chemotherapy.  Furthermore, we can improve clinical outcomes through patients reclassified towards chemotherapy following the Recurrence Score assessment."

The French study shows that the cost of chemotherapy drugs only represents a third of the total cost associated with chemotherapy, and that using Oncotype DX to guide chemotherapy decisions in France should decrease the overall healthcare costs while improving patient outcomes.  Consistently, results from the Irish and German studies show that Oncotype DX is likely to be cost-effective in local clinical practices.

Additional Results Presented at SABCS Reconfirm the Independent Value of the Oncotype DX Recurrence Score and Include the Following Data Highlights:

• The West German Study Group presented data from the largest European study to date (more than 2,500 patients) to include the Oncotype DX assay as a treatment decision tool.  The correlation of the Oncotype DX Recurrence Score and tumor grade, the immunohistochemistry biomarker Ki-67 and uPA/PAI-1 were all weak to poor, supporting the conclusion that the Recurrence Score result cannot be predicted by these clinical and pathology assessments. 
• An analysis of more than 207,000 Oncotype DX breast cancer test results demonstrates consistency in results over time for both the multigene Recurrence Score and the quantitative single gene results including ER, PR, and HER2.

Additionally,

• A concordance study from Venezuela used RT-PCR by Oncotype DX for quality control of ER, PR and HER2 status by IHC.
• A comparison of RS between paired core biopsy and surgical excision specimens in breast cancer patients shows a high degree of concordance.
• An exploratory study of Oncotype DX results in paired samples from primary tumor and lymph node metastases provides additional insights into tumor biology.
• Results of the study analyzing correlation of Oncotype DX Recurrence Score results with pathologic response following neoadjuvant ixabepilone and cyclophosphamide in patients with HER2-negative breast cancer are consistent with previous studies, reconfirming that the RS is highly predictive of the likelihood of achieving a complete pathologic response to neoadjuvant chemotherapy.

In addition to the studies highlighted above, Genomic Health also announced positive results from two other important studies during SABCS including:

• The oral presentation of positive results from a large validation study of Oncotype DX in patients with DCIS (ductal carcinoma in situ of the breast) conducted by the Eastern Cooperative Oncology Group, demonstrating that a pre-specified DCIS Score goes beyond traditional clinical and pathologic measures to predict the risk of local recurrence, defined as either the development of a new invasive breast cancer or the recurrence of DCIS in the same breast.  Based on this clinical validation study, Genomic Health will begin making its Oncotype DX Breast Cancer test available to physicians and DCIS patients on December 28, 2011.
• A poster presentation of the first-of-its-kind clinical outcomes study for biomarker discovery applying next generation sequencing (NGS) for whole transcriptome profiling of archival formalin-fixed paraffin embedded (FFPE) tumor specimens.  Results demonstrate that a proprietary RNA-Seq method developed at the company is capable of identifying validated genes that previously had been discovered by RT-PCR, the technology used to develop the Oncotype DX Breast Cancer test. 

About Genomic Health and the Oncotype DX® Tests

Genomic Health, Inc. (NASDAQ: GHDX) is a molecular diagnostics company focused on the global development and commercialization of genomic-based clinical laboratory services that analyze the underlying biology of cancer allowing physicians and patients to make individualized treatment decisions.

Its lead product, the Oncotype DX Breast Cancer test, has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in early-stage breast cancer to help optimize treatment options.  Oncotype DX is the only test incorporated in published ASCO® and NCCN® breast cancer treatment guidelines for patients with node-negative breast cancer that is estrogen-receptor positive and/or progesterone-receptor positive.[1]  The test is also recognized in international guidelines issued by St. Gallen International Breast Cancer Expert Panel and European Society for Medical Oncology (ESMO).

Physicians also use the Oncotype DX Breast Cancer test to make treatment recommendations for certain node-positive breast cancer patients.  Oncotype DX has been extensively evaluated in thirteen clinical studies involving more than 4,000 breast cancer patients worldwide, including a large validation study published in The New England Journal of Medicine and a chemotherapy benefit study published in the Journal of Clinical Oncology.

The Oncotype DX Colon Cancer test is the first multigene expression test commercially available that has been clinically validated to predict risk of recurrence in patients with stage II colon cancer.  Genomic Health collaborated with the National Surgical Adjuvant Breast and Bowel Project and Cleveland Clinic on a total of four development studies in more than 1,800 to analyze patients with stage II colon cancer.  The final gene panel was then independently evaluated in more than 1,400 stage II colon cancer patients in the QUASAR validation study.

As of September 30, 2011, more than 10,000 physicians in over 60 countries had ordered more than 230,000 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 stages of 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 planned launch of its Oncotype DX score for DCIS patients; the value the company's tests are delivering to physicians, payers and patients; the applicability of clinical study results to actual outcomes; the ability of the company's tests to optimize cancer treatment and  impact clinical practice; the impact of clinical studies on the use of the company's tests; the ability of the company to successfully market its products outside of the US; the ability of the company to develop additional tests in the future; the scope, success or results of clinical trials and the timing of such activities; and, the ability of the company's tests to be adequately reimbursed. 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 the company's tests by the FDA or similar agencies around the world; the results of clinical and cost effectiveness studies; the applicability of clinical study results to actual outcomes; our ability to develop and commercialize new tests; unanticipated costs or delays in research and development efforts; our ability to obtain and maintain reimbursement coverage for our tests; our ability to obtain capital when needed 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 period ended September 30, 2011. 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 and Recurrence Score are trademarks or registered trademarks of Genomic Health, Inc. All other trademarks and service marks are the property of their respective owners.

[1] ASCO and NCCN are registered trademarks of the American Society of Clinical Oncology (ASCO) and National Comprehensive Cancer Network (NCCN), respectively.  ASCO and NCCN do not endorse any product or therapy.

SOURCE Genomic Health, Inc.