Genomic Announces Positive Results From Clinical Validation Study Of Oncotype DX

(RTTNews) - Genomic Health, Inc. (GHDX) announced positive results from an additional independent clinical validation study of the Oncotype DX prostate cancer test, conducted in collaboration with the Uniformed Services University of the Health Sciences' or USU Center for Prostate Disease Research or CPDR supported by a multi-disciplinary team of investigators under a cooperative research and development agreement with USU.

The company said this new large study reconfirmed the biopsy-based test's Genomic Prostate Score or 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 following surgery.

Genomic noted that with the two endpoints meeting, 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. Furthermore, the study demonstrated that Oncotype DX is similarly predictive of outcomes in both Caucasian and African-American men.

The company also said that 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 within the Department of Defense healthcare system since 1990.

In this study, GPS results were obtained using archival biopsy tumor tissue from 402 men, including 82 African-American patients, 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. The analysis showed that GPS distribution was very similar between African-American and Caucasian patients.

It is noted that the Oncotype DX prostate cancer test addresses the unique challenges in making treatment decisions for men with low-risk, clinically localized prostate cancer by identifying patients who can consider active surveillance with greater confidence and thus avoid unnecessary treatment, as well as those men who have more aggressive disease and should consider immediate treatment.