Genomic Health Announces Presented Two Studies at ASCO Related to Oncotype DX(R) Test

Genomic Health, Inc. 

today announced results of two studies demonstrating the ability of its Oncotype DX^® test and a new 16-gene panel to predict disease aggressiveness and clinical outcomes in prostate and renal cancers, respectively. These results, presented at the American Society of Clinical Oncology^® (ASCO^®) Annual Meeting in Chicago, underscore the company's successful approach to understanding tumor biology, resulting in tests that incorporate distinct genes across multiple pathways to provide more precise risk assessment than currently available risk factors and help improve treatment decision making. "Based upon our extensive experience across cancers, we have observed that each cancer has a unique set of genes with expression that is most strongly associated with outcome," said Phil Febbo, M.D., chief medical officer, Genomic Health. "Our approach in breast, colon, prostate cancers – and now, in renal cancer – reflects our ability to select those genes and pathways that can inform critical treatment decisions and individualize patient care." In the prostate cancer study, researchers at the University of California, San Francisco (UCSF) conducted an analysis of 395 patient samples to evaluate the ability of the Oncotype DX Genomic Prostate Score (GPS) to predict cancer aggressiveness despite variability in pathology assessment. The analysis revealed that original pathology readings of tumor grade and stage, rendered by more than 15 pathologists, frequently differed from the central review that was performed by a single expert urologic pathologist as part of the clinical validation study. For both biopsy and radical prostatectomy specimen evaluation, the pathology results for Gleason Score were different in one out of every four patients (24 percent and 26 percent, respectively). Despite these discordances, GPS remained a robust predictor of adverse pathology at surgery. "These results demonstrate that the Oncotype DX GPS remains prognostic of disease aggressiveness in the face of differing pathology assessments," said Matthew Cooperberg, M.D., assistant professor of urology, epidemiology and biostatistics, UCSF.  "This test measures the heterogeneous biology of prostate cancer and represents a personalized approach to predict disease aggressiveness."   Separately, an independent, prospectively conducted study provided clinical validation of a 16-gene signature developed by Genomic Health to predict disease recurrence after surgery in patients with clear cell renal cell carcinoma (ccRCC). A consortium of French researchers conducted an analysis of 626 patients who were treated with surgery and then followed for a median of five and a half years. They demonstrated that the 16-gene panel was able to predict clinical outcomes in patients with stage I, II and III ccRCC and provide significant information beyond conventional clinical and pathologic characteristics. This panel includes genes from four pathways: vascular, immune response, cell growth and division, and inflammation. It was developed as part of a collaboration agreement with Pfizer, Inc. and could potentially be useful in guiding treatment as effective adjuvant therapies emerge.