Genomic Health, Inc. (GHDX) reported results from twin studies validating the capacity of the company's Oncotype DX test and a new 16-gene panel in predicting disease aggressiveness and clinical outcomes in prostate and renal cancers, respectively. The results were presented at the American Society of Clinical Oncology (TATD) Annual Meeting in Chicago.
The company's shares gained around 3.4% in the trading session following the news release. The stock is up around 3.1% since the announcement (based on yesterday's closing).
These results testify that researchers at Genomic Health have succeeded in apprehending tumor biology. Tests conducted integrate distinct genes across multiple pathways so as to deliver more accurate risk assessment to patients compared to currently available risk factors. This, in turn, helps both physicians and patients to take more improved treatment decisions.
In the prostate cancer study, an analysis of 395 patient samples was conducted by researchers at the University of California, San Francisco (:UCSF). The purpose of the study was to evaluate whether the Oncotype DX Genomic Prostate Score (GPS) can predict cancer aggressiveness despite variability in pathology assessment.
The study confirmed that original pathology readings of tumor grade and stage, by more than 15 pathologists, in most cases differ from the central review of 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 varied in one out of every four patients.
Nevertheless, Oncotype DX GPS continues to remain a strong predictor of adverse pathology at surgery – as a test that measures the heterogeneous biology of prostate cancer.
In a separate development, an independent study was conducted to clinically validate a 16-gene signature panel developed by Genomic Health. The purpose of this study was to evaluate whether the 16-gene panel can predict disease recurrence in post-surgery patients with clear cell renal cell carcinoma (ccRCC).
In the renal cancer study, 626 patients were analyzed by a consortium of French researchers. These patients were treated with surgery and then followed for a median of five and a half years.
Study results revealed that the 16-gene panel has the ability to predict clinical outcomes in patients with stage I, II and III ccRCC. It can also provide significant information beyond conventional clinical and pathologic characteristics. This panel was developed as part of a collaboration agreement with Pfizer Inc. (PFE) and has the potential to guide treatment using effective emerging adjuvant therapies.
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