REDWOOD CITY, Calif., May 15, 2015 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced results from three studies that show the real-world positive impact of the Oncotype DX® Genomic Prostate Score (GPS) and the test’s value in managing healthcare costs associated with treatment decisions in low-risk patients. The data were presented at the 2015 American Urological Association (AUA) Annual Meeting in New Orleans.
Oncotype DX Prostate Cancer Test Improves Risk Assessment for 1 in 4 Patients
An analysis of the performance of the Oncotype DX GPS in the first 4,000 men tested showed that the test refined patient risk for one in four men across all groups of patients (25.2 percent).
“Our experience with the Oncotype DX prostate cancer assay accurately mirrors the results of the validation studies and reconfirms the performance and utility of this test,” said Aaron Katz, M.D., chairman, Department of Urology, Winthrop-University Hospital, New York. “This analysis provides real-life documentation of the test’s impact on patient risk assessment, a key driver for treatment recommendations.”
The largest shift in risk assessment was observed among NCCN® low-risk patients (48.2 percent). Of those patients, 36.9 percent had more favorable biology consistent with very-low risk, and 11.3 percent of patients had less favorable biology, consistent with higher-risk disease.
Use of Oncotype DX Can Reduce Cost of Prostate Cancer Care within Five Years
In a separate study, researchers analyzed Oncotype DX test results from 200 U.S. prostate cancer patients to see how the change in their treatment decision based on the GPS results affected the cost of their treatment. Results showed that immediate treatment costs declined by more than $5,700 per patient. This reduction in costs was associated with increased use of active surveillance from 44 percent to 70 percent of the time. These results indicate that incorporating GPS into treatment decisions can reduce overall healthcare costs within five years.
“Similar to results we’ve seen with our breast cancer test, these new findings in prostate cancer underscore the significant value that Oncotype DX provides not only to urologists and prostate cancer patients, but also to the U.S. healthcare system,” said Phil Febbo, M.D., chief medical officer, Genomic Health. “To date, more than 1,800 urologists have ordered the Oncotype DX prostate cancer test. With the growing body of clinical evidence, including published clinical validation and utility studies focused on men who are candidates for active surveillance, we believe we are well positioned to achieve reimbursement, enable broader patient access, and reduce the burden of early-stage prostate cancer on patients and on the healthcare system.”
Genomic Health Continues to Examine Prostate Cancer Biology in African-American Men
To further advance the understanding of the use of genomics in African-American men with prostate cancer, Genomic Health researchers analyzed data compiled from four different Oncotype DX prostate cancer test studies involving 138 African-American patients. Results of this analysis showed that the tumor biology measured by the Oncotype DX GPS was similar between African-American and Caucasian men, reinforcing findings from the second validation study conducted in collaboration with the Uniformed Services University of the Health Sciences’ Center for Prostate Disease Research (CPDR).
“Demonstrating the clinical performance of molecular-based prognostic assays in African-American men is especially important because prostate cancer appears to be more aggressive in African Americans, and active surveillance may carry increased risk for progression,” said James Mohler, M.D., chair, Department of Urology, Roswell Park Cancer Institute, Buffalo, N.Y. “The North Carolina-Louisiana Prostate Cancer Project was pleased to contribute to this important multicenter analysis, which shows that the predictive value of this test is very similar in African Americans and Caucasians.”
Separately, in renal cancer, this week The Lancet Oncology published the results of an independent, prospectively conducted clinical validation of a 16-gene signature developed by Genomic Health to predict disease recurrence after surgery in patients with early-stage kidney cancer. The study results demonstrate the importance of utilizing multiple biological pathways to predict tumor behavior, highlighting Genomic Health’s unique approach to cancer genomics across various cancers.
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: @GenomicHealth, Facebook, YouTube 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 company’s test to physicians, patients and the healthcare system, the ability of its tests to change treatment decisions, and the company’s positioning to achieve reimbursement. 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; 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 quarter 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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