GenomeDx Announces Presentation of Positive Results From New Validation Study for Decipher® at the Annual Meeting of the American Society for Radiation Oncology (ASTRO) in San Francisco

SAN FRANCISCO, Sept. 17, 2014 /PRNewswire/ -- GenomeDx Biosciences today announced that data featured in an oral presentation at the 56^th Annual Meeting of the American Society for Radiation Oncology (ASTRO) demonstrates convincing evidence of the ability of the Decipher® Prostate Cancer Classifier to predict which patients may benefit from radiotherapy after prostate surgery.

"The genomic classifier used in this study was able to classify patients at high risk of metastasis and predict patients most likely to benefit from adjuvant radiation therapy more accurately than the clinical tools we use today," said Robert Den, M.D., Assistant Professor of Radiation Oncology and Cancer Biology at Thomas Jefferson University. "Integration of genomic test results into clinical practice can often give physicians additional insight into the aggressiveness of cancer and increase confidence in the selection of therapy."

The presentation (abstract #347) delivered today at 4:00pm PT by Dr. Den, titled "Validation of a genomic classifier for predicting metastasis following post-operative radiation therapy in high-risk prostate cancer," outlined results from a validation study of Decipher use in 188 patients and provides rationale for migrating to genomic testing in postoperative prostate cancer patient management:

1)      Improved prognostic value: Decipher better distinguishes those who are high risk of metastasis compared to other clinical tools

• 71 patients (42.5%) with average and high-risk CAPRA-S scores, a widely accepted risk classifier, were reclassified as low risk based on Decipher test results
• 96% of Decipher low risk patients were metastasis free within five years of surgery

2)      Indication of predictive value for improved decision making: Decipher determines which patients are likely to benefit from adjuvant radiation therapy (ART) vs. salvage radiation therapy (SRT)

• For Decipher high-risk patients, a significant difference (17%) in metastasis was observed at 5 years for the adjuvant (6%) compared to salvage (23%) arm (p=0.008), indicating that Decipher high-risk men may benefit from adjuvant radiotherapy after surgery.
• The study demonstrated an 80 percent reduction in hazards for high-risk patients who received ART compared to SRT

The study included 188 patients from Thomas Jefferson University and Mayo Clinic who underwent prostate surgery between 1990 and 2009.  Decipher test results and CAPRA-S scores, a post-surgical clinical tool used to calculate risk of prostate cancer recurrence after first-line surgery, were generated for these patients. Results of the Decipher test were then compared with those from CAPRA-S testing to determine the prognostic accuracy of the models using c-index and decision curve analysis.

This was the third Decipher study presented during the ASTRO meeting in San Francisco this week.  Presentation of these results was proceeded by presentation of results from two additional studies demonstrating (1) the clinical utility of Decipher when implemented by radiation oncologists into clinical care and (2) an outcomes modeling study which suggests that use of Decipher to guide postoperative radiation treatment decisions is associated with improved patient quality of life outcomes when compared with decision-making made in the absence of genomic information provided by Decipher.  These two studies were presented during the Quality of Life Following Radiotherapy for Prostate Cancer session on September 15:

1.       Abstract # 2850: 'Impact of a genomic classifier of metastatic risk on post-prostatectomy treatment recommendations by radiation oncologists and urologists' Nguyen et al.

2.       Abstract #2951: 'Reconsidering adjuvant versus salvage radiotherapy for prostate cancer using an individualized decision analysis with genomic classifier scores' Trifiletti et al.

About Decipher®
The Decipher® Prostate Cancer Classifier directly measures a patient's biological risk of developing 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 risk factors. Decipher continues to demonstrate that it can accurately predict aggressive disease and help physicians make more informed treatment decisions for men with prostate cancer.

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

About GenomeDx
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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SOURCE GenomeDx Biosciences