Studies Show that GenomeDx Biosciences' Decipher® Test is a Better Predictor of Metastatic Prostate Cancer than Existing Tools Two Studies Presented at 2014 AUA Annual Meeting

SAN DIEGO, May 20, 2014 /PRNewswire/ -- GenomeDx Biosciences today announced the presentation of data showing that its Decipher® Prostate Cancer Classifier, a genomic test capable of predicting metastatic prostate cancer, was able to identify patients that may be spared of radiation therapy after prostate surgery who would have been otherwise classified as high risk based on current clinical practice guidelines. In a separate study, data showed that Decipher outperformed existing clinical tools for predicting treatment failure in patients following prostate surgery. The posters were presented today at the 2014 American Urological Association Annual Meeting occurring in Orlando, Florida.

Treating men with prostate cancer remains a clinical quandary. Nine out of 10 men with prostate cancer who are still considered high risk for metastasis following removal of their prostate will not develop metastases or die of prostate cancer. However, clinical guidelines recommend that all these high-risk patients be offered secondary radiation treatment to lessen the risk of developing metastatic disease. Studies suggest that the majority of the men who undergo prostate surgery do not need radiation therapy, which in the postoperative setting includes significant potential for complications and side effects such as erectile dysfunction and urinary incontinence.

"Inappropriate use of radiation therapy after radical prostatectomy can lead to more harm for patients than benefits," said Dr. Eric Klein, Chairman, Glickman Urological & Kidney Institute at Cleveland Clinic and principal investigator of the study. "Our study of high-risk prostatectomy patients who did not receive any adjuvant therapy suggests that genomic testing may further allow identification of many men who may be safely spared adjuvant radiation." Dr. Klein is a paid consultant for GenomeDx Biosciences.

In the first study, abstract number MP74-06, by Dr. Magi-Galluzzi, et al, titled "Independent validation of a genomic classifier in an at risk population of men conservatively managed after radical prostatectomy," Decipher results were generated for 183 patients who had been conservatively managed after prostate surgery at Cleveland Clinic between 1987 and 2008. Decipher had an area under the curve (AUC) of 0.78 (95% CI 0.64-0.91) for predicting distant metastasis in patients who had not been treated after prostatectomy with adjuvant therapy. In a multivariable analysis, Decipher was the predominant predictor of distant metastasis (p<0.001), and patients with high-risk Decipher results were nearly 5 times more likely to develop metastasis compared to those with low-risk results after adjusting for clinical risk factors (95% CI 1.75-12.77).

"A growing body of evidence indicates that genomic markers have the ability to identify patients at highest risk for metastases and are more accurate than clinical factors alone at predicting tumor metastasis and treatment failure," noted Dr. Edouard Trabulsi, Co-Director, Prostate Diagnostic Center at Thomas Jefferson University Hospital and presenting author of the study investigating the performance of Decipher. "Our study found that the Decipher genomic classifier predicted treatment failure and demonstrated improved risk stratification above clinical classifiers in two separate, independent cohorts of men receiving radiation therapy following prostate surgery."

The second study, abstract number MP79-01, by Dr. Trabulsi, et al. is titled "Validation of a genomic classifier for predicting clinical progression following post-operative radiation therapy in high-risk prostate cancer." In the study, researchers analyzed Decipher results from two cohorts of men treated with radiation after prostate cancer surgery. From the TJU cohort (n=139), cumulative incidence of biochemical failure post radiation therapy at 6 years post radiation therapy was 21% for low Decipher score, 40% for average Decipher score and 63% for high decipher score (p<0.00001). Cumulative incidence of clinical metastasis at 6 years post- radiation treatment from the Mayo cohort was 6.5%, 15% and 38% for low, average and high Decipher scores, respectively (p<0.0002). In pooled analysis, a multivariable model adjusting for concurrent hormone therapy shows that Decipher and pre-surgical PSA were the only significant predictors of metastasis after postoperative radiation (p=0.016).

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 new, unbiased and actionable information about the aggressiveness of a patient's tumor - information distinct from that provided by PSA and other clinical tools. Multiple clinical studies demonstrate that Decipher accurately predicts aggressive disease and helps 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 or as a part of GenomeDx's ongoing program of clinical studies. To learn more about ordering the Decipher test 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.

SOURCE GenomeDx Biosciences



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