Genomic Health, Inc.
May 12, 2017
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Oncotype DX® Genomic Prostate Score™ (GPS) Test Predicts 10-year Risk of Prostate Cancer-specific Death and Metastases in Patients with Early-stage Disease

With New Data Presented at American Urological Association 2017 Annual Meeting, the GPS Test Becomes the Only Prostate Cancer Genomic Test Validated to Predict Both Near-term Adverse Pathology and Long-term Outcomes

REDWOOD CITY, Calif., May 12, 2017 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced the presentation of new results from a large, community-based, multi-center clinical validation study conducted at Kaiser Permanente, confirming that the Oncotype DX® Genomic Prostate Score™ (GPS) test is a strong independent predictor of prostate cancer-specific death and disease progression (metastases) at 10 years in men with localized prostate cancer across all National Comprehensive Cancer Network (NCCN) clinical risk groups.

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"By measuring cancer aggressiveness based on tumor tissue from the diagnostic biopsy, the Oncotype DX GPS test provides physicians and their patients with an individualized risk of having adverse pathology, developing metastases and dying of prostate cancer," said Phil Febbo, M.D., chief medical officer, Genomic Health. "These strongly positive results complement our previously published validation studies and provide further confirmation that the GPS test can provide patients, physicians and payors with individualized information above and beyond clinical and pathological factors to make a quality treatment decision."

Using a high-quality, longitudinal patient database from Kaiser Permanente's Northern California region, researchers evaluated biopsy tissue from 259 patients across all clinical risk categories who were treated with radical prostatectomy, which was standard of care at the time, and followed for a median of approximately 10 years. The study included a broad spectrum of patients by clinical risk, age and race to reflect a typical contemporary clinical community-based setting. Patient samples were tested at the Genomic Health laboratory to produce GPS results in a blinded fashion.

Results showed a wide range of GPS scores within each NCCN risk group and confirmed that the GPS score was strongly associated with prostate cancer-specific death (p < 0.001) and metastases (p < 0.001) in multivariable analysis. Notably, a key finding was that patients in this study with very low-, low- or intermediate-risk prostate cancer and a GPS result of less than 20 did not develop metastatic disease or die from prostate cancer following radical prostatectomy. These latest data add to the growing body of clinical evidence supporting the value and utility of the Oncotype DX GPS test to guide treatment decisions in men with localized prostate cancer.

"When we select emerging biomarkers, genomic assays and radiologic technologies to enhance patient care, it is important to evaluate evidence-based data in order to ensure that we are optimally assessing a patient's cancer risk and therapeutic outcomes," said Neal D. Shore, M.D., FACS, medical director of the Carolina Urologic Research Center, who is not affiliated with this study. "Newly presented data at AUA 2017 augment prior published findings and clearly demonstrate the value and utility of the Oncotype DX Genomic Prostate Score test in providing information for physicians and patients to enhance decision making for newly diagnosed, localized prostate cancer."

About the Oncotype DX® Genomic Prostate Score™ (GPS) Test
Designed by Genomic Health based on results from multiple studies led by Cleveland Clinic and the University of California, San Francisco, the Oncotype DX Genomic Prostate Score test analyzes 17 genes across four biological pathways from tumor tissue removed during biopsy to provide an individual score that, in combination with other clinical factors, further clarifies the current and future risk of the cancer prior to treatment intervention. The test enables confident treatment decisions to provide the opportunity for low- and intermediate-risk patients to avoid prostatectomy or radiation - and their side effects - while identifying men who need immediate definitive treatment. To learn more about the Oncotype DX Genomic Prostate Score test, visit www.OncotypeDX.com or www.MyProstateCancerTreatment.org.

About Genomic Health 
Genomic Health, Inc. (NASDAQ: GHDX) is the world's leading provider of genomic-based diagnostic tests that help optimize cancer care by addressing the overtreatment of the disease, one of the greatest issues in healthcare today. With its Oncotype IQ® Genomic Intelligence Platform, the company is applying its world-class scientific and commercial expertise and infrastructure to lead the translation of clinical and genomic big data into actionable results for treatment planning throughout the cancer patient journey, from diagnosis to treatment selection and monitoring. The Oncotype IQ portfolio of genomic tests and services currently consists of the company's flagship line of Oncotype DX gene expression tests that have been used to guide treatment decisions for more than 750,000 cancer patients worldwide. Genomic Health is expanding its test portfolio to include additional liquid- and tissue-based tests, including the recently launched Oncotype SEQ® Liquid Select™ test. The company is based in Redwood City, California, with international headquarters in Geneva, Switzerland. For more information, please visit, www.GenomicHealth.com and follow the company on Twitter: @GenomicHealthFacebookYouTube and LinkedIn.

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. 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: our business model; the applicability of clinical study results to actual outcomes; the impact of results from clinical studies on market adoption of Oncotype DX tests or demonstrating clinical utility; unanticipated costs or delays in research and development efforts; and other risks and uncertainties set forth in our filings with the Securities and Exchange Commission, including our most recent report on Form 10-K for the year ended December 31, 2016. 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, DCIS Score, Oncotype SEQ, Liquid Select, Genomic Prostate Score, Oncotype DX AR-V7 Nucleus Detect and Oncotype IQ are trademarks or registered trademarks of Genomic Health, Inc. All other trademarks and service marks are the property of their respective owners.

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SOURCE Genomic Health, Inc.

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