ESMO 2014: Genomic Health Announces Positive Results from Latest Clinical Validation Study of Oncotype DX® Prostate Cancer Assay

Genomic Health, Inc. announced strongly positive results from an additional independent clinical validation study of the Oncotype DX® prostate cancer test. This new large study reconfirmed the biopsy-based test's Genomic Prostate Score (GPS) as a predictor of adverse pathology at surgery and, for the first time, validated GPS as a strong independent predictor of a rise in prostate-specific antigen (PSA) following surgery (biochemical recurrence). In meeting these two endpoints, the Oncotype DX prostate cancer test provides both clinically actionable and long-term outcomes information for men with newly diagnosed low- and intermediate-risk prostate cancer.

The key results of this large prospectively-designed study in 402 patients are based on the CPDR multi-center national database, which has tracked men treated for prostate cancer since 1990, and showed:

The biopsy-based Oncotype DX GPS was a robust and independent measure of multiple clinically relevant endpoints, including adverse surgical pathology (p<0.001) and long-term risk of biochemical recurrence after surgery (p<0.001);

The Oncotype DX GPS was very similarly predictive of outcomes in Caucasian and African-American men regardless of their race. African-American men represented 20 percent of this study's patient population;

The established multiple prostate cancer-specific pathways contributed to the robust predictive value of the Oncotype DX GPS.

In this study, GPS results were obtained using archival biopsy tumor tissue from 402 men, treated with radical prostatectomy for NCCN very low-, low- or intermediate-risk prostate cancer at two U.S. military medical centers between 1990 and 2012.

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