2014

Study Shows GenomeDx's Decipher™ Test Effectively Predicts Rapid Metastatic Prostate Cancer Two Johns Hopkins University School of Medicine studies presented at the 2013 AUA Annual Meeting demonstrate Decipher's ability to outperform existing tools for predicting metastasis and disease progression

SAN DIEGO, May 8, 2013 /PRNewswire/ -- GenomeDx Biosciences today announced that data presented by Johns Hopkins University School of Medicine researchers at the 2013 Annual Meeting for the American Urological Association demonstrated that Decipher™, a transformative genomic test that provides a readout of the risk of metastatic disease for individual men with prostate cancer, predicted the onset of rapid metastatic disease (RMD) in patients following radical prostatectomy (RP). In addition, a second study showed that Decipher was a better predictor of metastatic progression than other clinicopathologic variables in men who had experienced a rise in PSA levels – also known as biochemical recurrence – following prostatectomy.

"Patients who experience metastasis of prostate cancer less than five years after RP are defined as having rapid metastatic disease," noted Doug Dolginow, MD, CEO of GenomeDx. "These patients are most likely to benefit from intensive multi-modal therapy, but predicting which patients have RMD is difficult. A technology such as Decipher could help identify those patients and get them appropriate treatment."

In a study presented by Ashley Ross, MD, PhD, assistant professor of urology at Johns Hopkins University School of Medicine, 4,903 men treated with RP at The Johns Hopkins Hospital who had at least 5 years of complete clinical follow up data were examined.   While use of nomograms based on clinical and pathologic features such as CAPRA-S and Stephenson were able to stratify men by risk within the entire surgical cohort, they demonstrated reduced ability to identify patients who would develop RMD in at-risk populations (such as those men who had adverse pathology at the time of prostatectomy or those who experienced biochemical recurrence).  This was primarily due to relatively low sensitivity of these tests. In collaboration with researchers from the Mayo Clinic, a separate cohort of 1,010 high-risk men, previously analyzed in a validation study for Decipher, were examined.  Clinico-pathologic nomograms demonstrated similar deficiencies in this cohort to those seen with patients from The Johns Hopkins Hospital.  When compared to clinico-pathologic nomograms, the use of the Decipher test allowed for superior accuracy in identifying men with RMD, with  absolute increases in sensitivity of 23 to 39% and an area under the curve of 0.79. 

In a separate study presented by Dr. Ross, researchers performed a subset analysis of validation data from the Mayo Clinic and found that Decipher was able to better predict metastasis in a group of high-risk men having already experienced biochemical recurrence (rising PSA) following prostatectomy. The results of the study showed that the cumulative incidence of metastasis three years after biochemical recurrence was 9% for patients with low Decipher scores but 43% for patients with high Decipher scores (p<0.001). Furthermore, Decipher was shown to outperform PSA doubling time which is currently the best surrogate for metastasis available in the clinic (AUC 0.82 vs. 0.69).

About Decipher™

Decipher™ is a transformative prognostic test that provides a direct measure of the true biological risk of potentially lethal metastatic prostate cancer independently of PSA level and other risk factors.  Decipher measures and analyzes the activity levels of multiple markers associated with aggressive prostate cancer to generate a patient's tumor-specific risk of disease progression after surgery (radical prostatectomy).  When used in conjunction with conventional risk assessment tools, validation data indicates that Decipher more accurately stratified a patient's risk for developing metastatic cancer following radical prostatectomy.

About GenomeDx Biosciences

GenomeDx Biosciences develops and commercializes genomic tests for prostate and other urologic cancers that have a real impact on treatment decision-making, improve patient outcomes and ultimately reduce healthcare costs. The company's first test, Decipher™, is a transformative prognostic test that provides a direct measure of the true biological risk of metastatic prostate cancer independent of PSA and other risk factors. GenomeDx is based in San Diego, California and Vancouver, British Columbia. More information is available at www.genomedx.com.

Mayo Clinic has a financial interest in technology licensed to GenomeDx.

SOURCE GenomeDx Biosciences



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