UCSF-led Study Shows Oncotype DX® and MRI May Provide Independent Information in Favorable Risk Prostate Cancer

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May 20, 2015 at 8:00 AM EDT

UCSF-led Study Shows Oncotype DX® and MRI May Provide Independent Information in Favorable Risk Prostate Cancer

REDWOOD CITY, Calif., May 20, 2015 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced results from a study led by the University of California, San Francisco (UCSF) showing a broad distribution of Oncotype DX® Genomic Prostate Score (GPS) results among prostate MRI findings, suggesting that these two technologies may provide non-overlapping clinical information in men with localized prostate cancer. 

"For the first time, we looked at the association between information provided by a genomic assay and a prostate MRI to better understand the value these two technologies bring to clinical practice," said Michael Leapman, M.D., lead investigator from UCSF. "These new data show that, in some patients, further risk stratification may be possible, and tools such as GPS may add important biological information to more precisely assess the aggressiveness of a patient's cancer."

In this study, researchers conducted a retrospective evaluation of the statistical association between the Oncotype DX GPS results and contributing gene groups with baseline endorectal MRI in 100 patients with clinically localized prostate cancer. The results showed a large variation of GPS results across MRI findings, demonstrating that Oncotype DX and MRI offer non-overlapping clinical insights in patients with early-stage prostate cancer.   

"The ability to predict whether a man is likely to harbor an aggressive form of the disease helps guide appropriate treatment discussion with the patient," said Peter Carroll, M.D., M.P.H., professor and chair, Department of Urology, UCSF. "With recent advances in imaging technology and the availability of a test such as Oncotype DX, physicians now have the ability to use both anatomical and genomic information to identify patients for active surveillance, as well as those who may need to consider an immediate treatment."

These new results follow the recent publication in Urology Practice of the first decision impact study of the Oncotype DX prostate cancer test that showed use of the test substantially increased the number of men who would be eligible for active surveillance while increasing physician confidence in their treatment recommendations. 

"We believe these results, as well as our recent clinical utility studies, underscore the value of Oncotype DX in providing important biologic information to improve risk assessment and treatment recommendations in patients with newly diagnosed prostate cancer," said Phil Febbo, M.D., chief medical officer, Genomic Health.

About Oncotype DX®
The Oncotype DX® portfolio of breast, colon and prostate cancer tests applies advanced genomic science to reveal the unique biology of a tumor in order to optimize cancer treatment decisions. The Oncotype DX prostate cancer test identifies which clinically low risk patients are eligible for active surveillance, as well as those who may benefit from immediate treatment by predicting disease aggressiveness.  With half a million patients tested in more than 80 countries, the Oncotype DX testing has redefined personalized medicine by making genomics a critical part of cancer diagnosis and treatment. To learn more about the Oncotype DX prostate cancer 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 address both the overtreatment and optimal treatment of early-stage cancer, one of the greatest issues in healthcare today. The company is applying its world-class scientific and commercial expertise and infrastructure to lead the translation of massive amounts of genomic data into clinically-actionable results for treatment planning throughout the cancer patient's journey, from diagnosis to treatment selection and monitoring. The company is based in  Redwood City, California, with European 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, including statements relating to the benefits of the test to physicians, patients and payors. 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 ability of test results to change treatment decisions; the risks and uncertainties associated with the regulation of the company's tests; the results of clinical studies; the applicability of clinical study results to actual outcomes; 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 risks of competition; 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 year ended March 31, 2015. 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.

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SOURCE Genomic Health, Inc.

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