GenomeDx's Decipher™ Test for Prostate Cancer Predicts Metastasis, Impacts Treatment Decisions

SAN DIEGO, Feb. 14, 2013 /PRNewswire/ -- GenomeDx Biosciences today announced new data supporting the clinical validation and utility of Decipher™, a transformative genomic test that forecasts risk of metastasis in men with prostate cancer. An analysis of men at risk of recurrence after prostate cancer surgery showed Decipher was a better predictor of metastasis than conventional risk assessment tools such as PSA, tumor stage and grade. A separate study found that the more accurate prediction of aggressive cancer provided by the Decipher test changed treatment recommendations and increased urologists' confidence in their decisions. The studies suggest that information provided by Decipher may enable physicians to make better treatment decisions for their patients after surgery. Data from four Decipher studies are being presented at the American Society of Clinical Oncology 2013 Genitourinary Cancers Symposium in Orlando, Florida.

"More accurate prediction of metastatic prostate cancer leads to better identification of patients that need to intensify therapy, and better identification of patients that can forgo expensive procedures with harmful side effects such as impotence and incontinence," said Doug Dolginow, M.D., CEO of GenomeDx. "Decipher leapfrogs shortcomings of conventional tools by focusing on the true biological risk of lethal cancer – the genes associated with metastatic disease."

In a study presented by Ghadessi et al., researchers generated Decipher scores for 219 patients from a prospectively-designed blinded validation study of patients following radical prostatectomy. The primary endpoint, the c-index for predicting metastatic disease progression (positive bone or CT scans), was evaluated in a blinded analysis. Decipher had a c-index of 0.79 (95% CI, 0.71-0.86) that was significantly better than any established clinical risk factors. Most of the patients (72%) from this 'high-risk' cohort were ultimately classified as low risk by Decipher with less than 3% incidence of metastasis at 5 years following prostate surgery. In contrast, patients classified by Decipher as high risk had nearly 10 times higher risk of developing metastasis and a multivariable analysis showed that Decipher remained the only significant independent predictor of metastasis (p<0.001).

"Historical data show that conventional risk assessment tools classify too many men as high risk for metastatic disease. A high risk classification can corner men into undergoing expensive therapies such as postoperative radiation that carry significant risk of permanent, life-changing effects including incontinence and erectile dysfunction," continued Dr. Dolginow. "These results suggest that Decipher may provide greater confidence in treatment decision making and in doing so, holds the potential to improve patient outcomes and ultimately save healthcare system dollars."

A separate study by Badani et al. evaluated the impact Decipher results have on postoperative treatment recommendations. In that study, urologic oncologists reviewed 240 patient cases that were classified by established clinical risk factors as high risk for metastasis following prostate surgery. Physicians were asked to make treatment recommendations before and after receiving Decipher test results. The researchers found that Decipher led to a change in treatment recommendation 43% (95% CI: 37-49) of the time. Significantly, recommendations for postoperative radiation were changed to observation for 31% of patient case evaluations.  

"Practice patterns among urologists and the current literature vary widely on which patients are at true risk for metastasis and for whom to intensify treatment for prostate cancer," said Dr. Ketan Badani, urologic oncologist at Columbia University in New York. "Our study demonstrates that practicing urologists will utilize genomic-based patient-specific information and trust this data to make treatment decisions for their patients."

Abstracts for other Decipher studies presented at ASCO GU are available online at:

http://gucasym.asco.org/content/107487-134

And

http://gucasym.asco.org/content/107343-134

About Decipher™
Decipher™ is a transformative prognostic test that provides a direct measure of the true biological risk of potentially lethal prostate cancer independent of PSA and other risk factors.  Decipher measures the expression levels of multiple markers associated with aggressive prostate cancer and provides additional information about a patient's risk of disease progression after surgery (radical prostatectomy).  When used in conjunction with conventional risk assessment tools, Decipher has the potential to more accurately stratify a patient's risk for developing recurrent or 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.

SOURCE GenomeDx Biosciences