2014

Genomic Health Announces Results From the Largest Genomic Analysis of Localized Clear Cell Renal Carcinoma at American Society of Clinical Oncology (ASCO) Annual Meeting First Publically Presented Results of Industry-Leading Collaboration Aimed to Assess Prognosis for Early-Stage Renal Cell Carcinoma

CHICAGO, June 4 /PRNewswire-FirstCall/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced the first results from its collaboration with Pfizer Oncology to study early-stage renal cell carcinoma prognosis, which demonstrated a strong correlation between gene expression and recurrence risk in this patient population.  The study, which will be presented in an oral presentation tomorrow (8 – 9:30 a.m. CT) at the ASCO annual meeting in Chicago, could lead to the development of a multi-gene diagnostic test that estimates the risk of recurrence following surgery and that may ultimately aid in the subsequent identification of early-stage patients with renal cell carcinoma who could benefit most from treatment.

"Many early-stage renal cell carcinoma patients experience a recurrence of their cancer, yet there is currently no accurate means to identify the most aggressive cancers in advance," said Brian Rini, M.D., staff oncologist at Cleveland Clinic Taussig Cancer Institute and principle investigator on the study (i). "The strong correlation between gene expression and recurrence risk demonstrated in this study could help select the appropriate renal cell carcinoma patients for future drug development trials and potentially identify patients most likely to benefit from adjuvant therapy following surgery."

The study, "Identification of Prognostic Genomic Markers in Patients with Localized Clear Cell Renal Cell Carcinoma" (Abstract 4501), is the largest genomic analysis of localized clear cell renal carcinoma performed to date.  Additionally, it represents the first publicly presented results of Genomic Health's collaboration with Pfizer Oncology for assessing prognosis in patients with stage 1-3 renal carcinoma, clear cell type, that has not spread to other parts of the body.

Researchers evaluated more than 700 candidate genes from 942 stage 1-3 clear cell renal carcinoma patients treated at Cleveland Clinic between 1985 and 2003.  Genomic factors strongly associated with risk of recurrence and clinical/pathologic covariates were identified.  The magnitude of hazard ratios was comparable to those of other clinically used prognostic markers, such as estrogen-receptor status and HER2 status in breast cancer.  Researchers suggest that these results could be used to create a multi-gene algorithm to predict recurrence of early-stage renal cell carcinoma.

"Genomic Health's collaboration with Pfizer represents an industry-leading example of academic, diagnostic and therapeutic organizations combining resources and areas of expertise in order to advance the field of personalized medicine," said Steven Shak, M.D., chief medical officer, Genomic Health.  "Similar to what Genomic Health found using its quantitative RT-PCR technology in breast and colon cancers, this study shows that renal carcinoma tumors are not all the same and we believe this finding has the potential to provide critical insight for determining how early-stage renal cell carcinoma is treated in the future."  

The clear cell type of renal carcinoma is the most common type of kidney cancer in adults, affecting an estimated 25,000 people each year in the United States, and the incidence of the disease may be increasing.  As part of the collaboration, Genomic Health and Pfizer applied the same molecular technology and clinical strategy Genomic Health used to develop its Oncotype DX® breast and colon cancer tests.

"We have the potential to individualize the treatment of early-stage renal cell carcinoma by assessing the risk of recurrence more accurately," said Isan Chen, M.D., Vice President - Genitourinary Tumor Strategy Team Leader, Pfizer Oncology Business Unit. "With a growing portfolio of kidney cancer therapies, Pfizer is committed to advancing the science and management of this disease.  Together with Genomic Health we intend to continue to define the clinical strategy and next steps for our work in renal cell carcinoma."

(i) Dr. Rini is also a member of the Pfizer scientific advisory board.  

About Genomic Health

Genomic Health, Inc. (NASDAQ: GHDX) is a life science company focused on the global development and commercialization of genomic-based clinical laboratory services for cancer that allow physicians and patients to make individualized treatment decisions. In 2004, Genomic Health launched the Oncotype DX® breast cancer test, which has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in early-stage breast cancer. In addition to the widely adopted Oncotype DX breast cancer test, Genomic Health launched its Oncotype DX colon cancer test in January 2010. As of March 31, 2010, more than 10,000 physicians in over 55 countries had ordered more than 148,000 Oncotype DX tests. The company was founded in 2000 and is located in Redwood City, California. For more information, please visit www.genomichealth.com.

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the belief that the study data could lead to the development of a multi-gene diagnostic test to estimate the recurrence risk in  renal cell carcinoma patients and possibly aid in the identification of patients who could most benefit from adjuvant  treatment, the belief that its collaboration with Pfizer represents an industry-leading example of combining resources and expertise to advance the field of personalized medicine, the belief that our prior development and commercialization strategy can be applied to renal cell carcinoma, our expectations regarding the size of the potential market, the continuation and success of our collaboration with Pfizer, and the applicability of clinical study results to actual outcomes. 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 the collaborative arrangement; 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, 2010. 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.

SOURCE Genomic Health, Inc.



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