Genomic Health Announces Availability of Oncotype DX® Prostate Cancer Test with Potential to Triple the Number of Patients Who Can Confidently Choose Active Surveillance and Avoid Side Effects of Invasive Treatments

Groundbreaking Results from University of California, San Francisco (UCSF) Clinical Validation Study Presented at American Urological Association (AUA) Annual Meeting
First-of-its-Kind, Biopsy-Based Test Developed and Validated in Seven Studies Including More Than 1,100 Patients

Genomic Health, Inc. (GHDX) is making its Oncotype DX® prostate cancer test available to physicians and their patients today following the presentation by the University of California, San Francisco (UCSF) of a positive clinical validation study at the 2013 American Urological Association (AUA) Annual Meeting in San Diego. 

Results showed that the test, developed in collaboration with UCSF and Cleveland Clinic, strongly predicted disease aggressiveness (p=0.002) offering information beyond currently available clinical factors, such as PSA and biopsy Gleason Score, to help physicians and their prostate cancer patients confidently choose the most appropriate treatment based on an individualized risk assessment. Furthermore, this first-of-its-kind, multi-gene test has been validated to guide treatment decisions using the prostate needle biopsy sample taken before the prostate is removed -- thereby providing the opportunity for low risk patients to avoid invasive treatments such as radical prostatectomy or radiation. 

"The results of our study showed that the individual biological information from the Oncotype DX prostate cancer test tripled the number of patients who can more confidently consider active surveillance and avoid unnecessary treatment and its potential side effects. The test also identified a smaller number of patients who, despite seemingly low-risk clinical factors, had more aggressive disease and, would suggest that they consider immediate treatment," said Peter Carroll, M.D., MPH, professor and chair, Department of Urology, UCSF and principal investigator of this validation study.  "With these new study results, I believe we may be able to significantly increase the use of active surveillance, which has been limited to some extent by the absence of a validated genomic tool to more accurately distinguish low and high risk disease at the time of biopsy."

Active surveillance is a treatment plan that employs careful and consistent monitoring of the cancer in a man's prostate without removing it.  Under active surveillance, patients have regular check-ups and periodic PSA blood tests, clinical exams and potential biopsies to closely monitor for signs of prostate cancer progression.

The Oncotype DX prostate cancer test measures the level of expression of 17 genes across four biological pathways to predict prostate cancer aggressiveness.  The test results are reported as a Genomic Prostate Score (GPS) that ranges from 0 to 100 and is combined with other clinical factors to further clarify a man's risk prior to treatment intervention.

Positive Results from UCSF-led Validation Study

In the UCSF validation study of 395 patients, adding the biological information revealed by the GPS significantly increased the number of patients identified as having very low risk disease and thus appropriate for active surveillance (from 5-10  percent to 26 percent).  Specifically, more than one-third of patients originally classified as low risk based on clinical measures were identified by GPS as very low risk and could confidently choose active surveillance.  Importantly, approximately 10 percent of patients originally classified as very low or low risk by clinical factors were identified by GPS as having more aggressive disease, which would be considered for immediate treatment. 

"Genomic Health is dedicated to providing answers for the most critical clinical questions in cancer treatment by utilizing genomics to help physicians and patients optimize treatment decisions," said Steven Shak, M.D., chief medical officer and executive vice president of research and development, Genomic Health.  "The Oncotype DX prostate cancer test addresses one of the most significant issues in men's health today to help reduce the personal and economic toll of prostate cancer overtreatment."

Development in Collaboration with Cleveland Clinic

To develop the Oncotype DX prostate cancer test, Genomic Health conducted six feasibility and development studies in collaboration with Cleveland Clinic evaluating more than 700 patients. 

"Our extensive development studies tackled the key challenges inherent in prostate cancer risk assessment to identify a subset of genes that are important in both low-grade and high-grade tumors," said Eric A. Klein, M.D., chairman, Glickman Urological and Kidney Institute, Cleveland Clinic and principal investigator for the Cleveland Clinic's original development studies.  "This helped us overcome tumor heterogeneity as well as biopsy under-sampling and under-staging to develop the Oncotype DX prostate cancer test and substantially improve risk assessment at the time of diagnosis."

In the development studies, an optimized RT-PCR platform was used to measure and analyze gene expression in prostate cancer tissue samples from both radical prostatectomy and very small needle biopsy specimens.  Out of more than 700 candidate genes, 81 genes were selected to be tested in biopsy samples.  The final analysis yielded 17 genes across four biologic pathways and a precise and reproducible GPS to accurately predict disease aggressiveness of the entire prostate prior to intervention.

Current Prostate Cancer Treatment Dilemma

Of the over 240,000 U.S. men diagnosed with prostate cancer each year, about half will be classified as low risk using conventional measures such as Gleason Score, PSA, and physical exam.  While multiple guidelines endorse active surveillance for low-risk prostate cancer, 90 percent of these low risk patients undergo immediate treatment such as radical prostatectomy or radiation, despite less than a 3 percent chance of low risk disease progressing and ultimately becoming deadly. 

"For men with prostate cancer, the ability to more precisely define their risk level for aggressive disease is a significant leap forward," said Howard Soule, executive vice president and chief science officer of the Prostate Cancer Foundation.  "Now men can have greater confidence in their treatment plans, knowing decisions are being made based on their individual biological information."

Genomic Health is providing a new web-based resource for patients and their loved ones with information about prostate cancer treatment options and the role of genomics in making treatment decisions: www.myprostatecancertreatment.org.

This is the second distribution of the Genomic Health release first distributed at 12:01 p.m. Eastern Time on Wednesday, May 8, 2013: http://www.multivu.com/mnr/61468-genomic-health-positive-validation-study-oncotype-dx-prostate-cancer. 

About Genomic Health

Genomic Health, Inc. (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 and now the Oncotype DX prostate cancer test for men with low risk disease. As of March 31, 2013, more than 19,000 physicians in over 75 countries had ordered more than 350,000 Oncotype DX tests.  Genomic Health has a robust pipeline focused on developing tests to optimize the treatment of 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 and www.myprostatecancertreatment.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 company's belief that its launch of a test for prostate cancer represents offers information beyond standard measures and  which will change clinical practice; the belief that its prostate cancer test  will lead to long-term growth beyond its existing core markets; the attributes of any such test; the success or results of clinical trials and the timing of such activities; the applicability of clinical study results to actual outcomes; the ability of the company's tests to impact clinical practice; and the focus and attributes of the company's product pipeline. 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: risks related to the commercial launch of a new test for prostate cancer; the company's ability to increase usage of its tests; 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 company's success retaining current contracts or levels of reimbursement coverage for its tests; the risks and uncertainties associated with regulation of the company's tests by the FDA and other regulatory organizations; the company's ability to compete against third parties; the company's ability to develop and commercialize new tests; unanticipated costs or delays in research and development efforts; the success of the company's next generation sequencing technology; the company's ability to successfully commercialize its tests outside of the United States; the ability to obtain capital when needed; the company's history of operating losses; the results of clinical studies; the applicability of clinical study results to actual outcomes; 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 March  31, 2013. 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.