Genomic Health Presents Results From First Clinical Decision Making Study of Oncotype DX® Colon Cancer at the 2012 Gastrointestinal Cancers Symposium

REDWOOD CITY, Calif., Jan. 20, 2012 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced positive results of the first clinical decision making study of the Oncotype DX® colon cancer test that shows that Recurrence Score® (RS) result has a significant impact on treatment recommendations for stage II colon cancer patients.  The data, to be presented at the 2012 Gastrointestinal (GI) Cancers Symposium, demonstrate that knowledge of a patient's Recurrence Score changes medical oncologists' treatment recommendations in 29 percent of cases, further confirming the clinical utility of using Oncotype DX as an independent predictor of recurrence in stage II colon cancer.   These results are also consistent with the change rate of approximately 30 percent that has been observed in studies evaluating the impact of the Oncotype DX breast cancer test on treatment decisions in early-stage breast cancer patients.

"The Oncotype DX colon cancer test was made available in 2010 based on results from the landmark QUASAR study and is designed to help physicians optimize care for stage II colon cancer patients by analyzing the underlying biology of their individual tumors," said Steven Shak, M.D., chief medical officer of Genomic Health.  "These new results support our efforts to gain broad reimbursement coverage and increase patient access, and highlight the independent value beyond conventional measures that the test provides to physicians, patients and payors."

To characterize the impact of the Oncotype DX test on adjuvant treatment recommendations in stage II colon cancer, U.S. medical oncologists who had used the test on three or more patients participated in a survey to assess how the Recurrence Score impacted their treatment decisions.  Out of the 92 patients who had treatment recommendations before having Oncotype DX testing, physicians changed treatment recommendations based on the Recurrence Score results in 27 patients (29 percent).  Two-thirds (67 percent) of changes in treatment recommendations were decreases in treatment intensity (changes from chemotherapy to observation or from oxaliplatin-containing chemotherapy to treatment with fluoropyrimidine monotherapy), while one-third (33 percent) of changes were increased treatment intensity.

"In the past, selection of stage II patients for chemotherapy treatment following surgery has been based on a limited set of clinical and pathologic markers that are uninformative for most patients," said Thomas H. Cartwright, M.D., Ocala Oncology, Ocala, Florida, and the principal investigator of this study. "The Oncotype DX colon cancer test has been clinically validated as a predictor of individual recurrence risk for stage II colon cancer patients, providing quantitative information about recurrence risk which has not been available with conventional measures.   The test is now being used in treatment planning by physicians and patients worldwide, and represents an important advancement in bringing personalized medicine into today's clinical setting to benefit patients."

The new clinical decision-making data adds to the growing list of recent colon cancer milestones achieved by Genomic Health including:

• Publication of the positive results from the landmark QUASAR clinical validation study in the Journal of Clinical Oncology, which established that the Oncotype DX colon cancer test predicts recurrence risk in stage II colon cancer patients following surgery and provides additional clinical value beyond conventional measures such as T-stage, mismatch repair (MMR) status, nodes examined, grade and lymphovascular invasion;
• Obtained Medicare coverage policy for the Oncotype DX colon cancer test, which ensures broader patient access to the test;
• Launched MMR testing for recurrence risk that allows physicians to identify the approximately 15 percent of stage II colon cancer patients with MMR-deficient tumors, who have low recurrence risk and thus may be more appropriately considered for observation following surgery; and
• Continued ongoing studies including a Mayo Clinic Cancer Research Consortium Clinical Trial to prospectively assess the impact of the Oncotype DX Recurrence Score on adjuvant therapy decision-making for stage II colon cancer patients, and a large gene identification study for prediction of oxaliplatin benefit in stage II and III colon cancer patients.

The 12-gene colon cancer Recurrence Score assay was developed using data from 1,851 patients in four large, independent studies conducted with the NSABP and Cleveland Clinic. "Effect of Oncotype DX colon cancer test results on treatment recommendations in patients with stage II colon cancer: Preliminary results" (Abstract #398) will be presented during the poster discussion session on January 21, 12:30 – 2:30 p.m.

Four leading medical specialty societies co-sponsor the three-day, multidisciplinary symposium, including the American Gastroenterological Association (AGA) Institute, the American Society of Clinical Oncology (ASCO), the American Society for Radiation Oncology (ASTRO) and the Society of Surgical Oncology (SSO). 

About Genomic Health and the Oncotype DX® Tests

Genomic Health, Inc. (NASDAQ: GHDX) is a global cancer company focused on the development and commercialization of genomic-based clinical laboratory services that analyze the underlying biology of cancer allowing physicians and patients around the world 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 improve treatment decisions.  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 DCIS and 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 December 31, 2011, more than 10,000 physicians in over 60 countries had ordered more than 250,000 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 ability of the test to optimize cancer treatment; the ability of the recurrence score  to impact  treatment decisions in a clinical setting;  the ability of the company to establish further coverage and reimbursement for its colon cancer test; the potential of the test to transform care for  colon cancer patients while saving the healthcare system money; the applicability of study results to clinical practice  and timing and results of future studies. 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; risks associated with competition and commercialization of  the test;  the risks and uncertainties associated with establishment of coverage and reimbursement;  additional  regulation of the company's tests; 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.