GenomeDx Biosciences' Decipher® Test Predicts Radiation Therapy Failure and Identifies Candidates for Early Radiation Therapy Following Prostate Surgery

SAN DIEGO, Jan. 30, 2014 /PRNewswire/ -- GenomeDx Biosciences today announced new data demonstrating that its Decipher® Prostate Cancer Classifier, a genomic test capable of predicting the probability of developing metastatic prostate cancer, outperformed existing clinical risk factors for predicting biochemical failure and distant metastasis following radiation therapy. In addition, researchers observed significant improvement in outcomes for patients with high risk Decipher results who received radiation therapy early rather than late after surgery.

The data will be presented today at the 2014 ASCO Genitourinary Symposium between 11:30 A.M. and 1:00 P.M. at Golden Gate Hall in San Francisco. Poster number 10, by Robert Den, et al, is titled "Validation of a genomic classifier for predicting biochemical failure following post-operative radiation therapy in high-risk prostate cancer."

"This is the first validation of the Decipher test in patients receiving radiation therapy following prostate surgery," said Dr. Adam Dicker, MD PhD, Chair of Radiation Oncology at the Kimmel Cancer Center.  "Decipher improved the ability to predict men at risk for biochemical failure and distant metastasis after postoperative radiotherapy over and above existing clinical risk factors such as Gleason score, tumor stage and PSA. These data indicate that patients with a high Decipher result may benefit from earlier radiation and a multi-modal approach to treatment."

In the study evaluating Decipher, 139 patients who had undergone radiation therapy after prostatectomy at Thomas Jefferson University between 1990 and 2009 were analyzed. RNA was extracted from the preserved tissue samples and run on the Decipher test. Patient histories were then analyzed to determine if Decipher was able to stratify patients who could have benefited from earlier radiation therapy. In patients identified as high risk by Decipher, those that got early radiation therapy survived for a median of eight years without biochemical failure, defined as an increase in PSA post radiation. This was compared to less than four years for patients that got late radiation therapy (p<0.001).  At eight years following radiation therapy, high risk Decipher patients that got early radiation therapy had a three percent cumulative incidence of metastasis versus 23 percent for patients with high risk Decipher results that got late radiation therapy (p<0.001).

"The findings of our study have ramifications for many of the current ongoing clinical trials evaluating post prostatectomy radiation therapy," noted Dr. Robert Den, MD, Radiation Oncologist at Kimmel Cancer Center and lead author of the study. "They suggest that there is a subset of patients who would benefit from immediate treatment and those who can afford to postpone therapy."

Three additional studies on Decipher will be presented during poster session A at ASCO GU today from 11:30 A.M. to 1:00 P.M.

• Poster #16: "Independent validation of a genomic classifier in an at risk population of men conservatively managed after radical prostatectomy" by Eric Klein, et al.
• Abstract #85: "Feasibility of transcriptome-wide biomarker assessment using prostate cancer FFPE needle biopsy specimens" by Beatrice Knudsen, et al.
• Abstract #151: "Effect of a genomic classifier on adjuvant radiation recommendations after prostate cancer surgery" by Ketan Badani, et al.

These studies add to the body of evidence for Decipher, which has been studied in over 1,800 patients.  Decipher measures 22 genomic biomarkers associated with metastatic cancer to generate a result that indicates the likelihood of metastasis. The result is completely independent of PSA and other existing clinical variables, providing new, unbiased and actionable information that physicians and patients can use to make post-operative treatment plans.

About Decipher®
The Decipher Prostate Cancer Classifier directly measures the biological risk of metastatic prostate cancer. By assessing the activity of multiple genomic markers associated with metastatic disease, Decipher provides information about the aggressiveness of a patient's tumor – information distinct from that provided by PSA and other clinical tools. Through an extensive program of clinical studies, Decipher continues to demonstrate its ability to more accurately distinguish metastatic disease and impact treatment decisions for men with prostate cancer.

Decipher is available to eligible US patients through their physicians and as a part of GenomeDx's ongoing program of clinical studies.

To learn more about the Decipher test, please visit www.deciphertest.com

About GenomeDx
GenomeDx Biosciences develops and commercializes genomic tests for prostate and other urologic cancers that impact treatment decision-making, improve patient outcomes and ultimately reduce healthcare costs. GenomeDx has developed the Decipher Prostate Cancer Classifier, the first and only commercially available genomic test that predicts the risk of developing metastatic prostate cancer independently of PSA and other conventional risk assessment tools. GenomeDx is based in San Diego, California and Vancouver, British Columbia.

Media Contact:
Carolyn Hawley 
Canale Communications
619-849-5375
[email protected] 

SOURCE GenomeDx Biosciences