Genomic Health,
Inc. GHDX 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.
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