GenomeDx Biosciences Release: Study Published In European Urology Shows That The Decipher Prostate Cancer Classifier Is Predictive Of Rapid Metastasis In High-Risk Men Who Have Had Prostate Surgery

SAN DIEGO, Dec. 22, 2014 /PRNewswire/ -- GenomeDx Biosciences today announced that a new study showed that the Decipher Prostate Cancer Classifier, a genomic test for prostate cancer, was able to predict rapid metastatic disease in node-negative, high-risk men managed by radical prostatectomy without adjuvant therapy. Although rapid metastasis in men treated with radical prostatectomy is relatively uncommon, using tumor genomics to identify these men who have a highly lethal form of metastatic disease is an important advance. The study has been published online by the journal European Urology.

The findings highlight the significance of identifying the patients at highest risk of rapid metastasis for timely treatment after surgery:

• Of men who had rapid metastasis within five years, while all initially had undetectable PSA after surgery and were indistinguishable by standard clinical and pathologic features, 50% developed bone metastasis by two years and 50% died of their disease by seven years after surgery.
• Of men experiencing late metastasis, none died of their prostate cancer at seven years after surgery and the median time to metastasis was over nine years.

"Clinical and pathological risk factors were not able to distinguish which among the patients at risk of recurrence in our cohort might develop rapid metastatic disease," said Eric Klein, M.D., Chairman of the Glickman Urological and Kidney Institute at Cleveland Clinic. "Identification of such patients is clinically relevant, as those at highest risk for rapid metastasis and death are mostly likely to benefit from earlier, more intensive therapy and inclusion in clinical trials of novel agents. Perhaps what is more important for the average patient treated with radical prostatectomy at our institution is the high negative predictive value of this genomic test.  Our study suggests that a patient with genomic low risk, despite having adverse pathology findings, is likely best managed conservatively after surgery and may safely avoid radiation therapy and the associated adverse side-effects." Dr. Klein is a paid consultant for GenomeDx Biosciences.

The study, titled "A Genomic Classifier Improves Prediction of Metastatic Disease Within Five Years After Surgery in Node-negative High-risk Prostate Cancer Patients Managed by Radical Prostatectomy Without Adjuvant Therapy," evaluated 169 patients who had a preoperative PSA of greater than 20 ng/mL, a negative pathologic node, undetectable PSA following prostate surgery and did not have neoadjuvant or adjuvant therapy. Fifteen patients experienced rapid metastasis, defined as occurring within five years of surgery, and 34 had late metastasis, defined as occurring more than five years after surgery. When the Decipher results were applied, Decipher demonstrated the highest prediction of metastatic disease compared to the Stephenson and CAPRA-S nomograms, with an AUC of 0.77 compared to 0.75 and 0.72 respectively. In addition, integration of Decipher into the Stephenson nomogram resulted in an increased performance as measured by AUC of 0.79.

"The clinical utility of Decipher in this patient population may have the most impact, beyond nomograms, on identifying more patients who, despite having multiple adverse pathology findings after surgery, have a high probability of metastasis-free survival even when managed conservatively without adjuvant therapy," said Elai Davicioni, Ph.D, founder and CSO of GenomeDx. "Further, this study showed that Decipher was able to better identify the few patients with a highly lethal form of metastatic disease who have the most to benefit from earlier, more intensive adjuvant therapy."

About Decipher
The Decipher® Prostate Cancer Classifier directly measures a patient's biological risk of developing metastatic prostate cancer. Based on a whole genome profile of a patient's tumor, Decipher predicts the aggressiveness of a patient's disease based on genomic information that is distinct from that provided by PSA and other clinical risk factors. Clinical studies have demonstrated that Decipher can accurately predict aggressive disease and help physicians make more informed treatment decisions for men with prostate cancer. Decipher was developed in partnership with the Mayo Clinic.

Decipher is covered multiple private insurance plans and is available to eligible US patients through their physicians. To learn more about Decipher please visit www.deciphertest.com.

About GenomeDx Biosciences
GenomeDx Biosciences is focused on transforming patient management by putting usable genomic information in the hands of patients and their physicians. 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. To learn more visit www.genomedx.com.

Media Contact:
Ian Stone
Canale Communications
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ian@canalecomm.com

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SOURCE GenomeDx Biosciences