SAN DIEGO, Jan. 7, 2016 /PRNewswire/ -- GenomeDx Biosciences today announced the first validation data supporting use of the Decipher® Prostate Cancer Classifier in analysis of diagnostic needle core biopsies to help guide the management of newly diagnosed men with prostate cancer. The data will be presented at the 2016 Genitourinary Cancers Symposium in San Francisco by Eric Klein, M.D., Chairman of the Glickman Urological and Kidney Institute at Cleveland Clinic.
Decipher, which has been extensively validated in over 3,000 patients for metastasis prediction after radical prostatectomy, accurately predicted 10-year post-operative metastasis from genomic analysis of diagnostic biopsy specimens. Decipher scores were evaluated from a cohort of primarily low- and intermediate-risk disease patients with available needle biopsy tissue who went on to receive radical prostatectomy at Cleveland Clinic. Notably, Decipher reclassified 66.6% of intermediate-risk patients, as assessed by the National Comprehensive Cancer Network's (NCCN) guidelines' risk groups, into either lower (48.1%) or higher (18.5%) Decipher risk groups. The results of the study show the potential of Decipher to improve clinical decision-making even upon initial diagnosis of prostate cancer.
"Advancing research on the next generation of genomic tests for prostate cancer patients allows us to continue to refine our ability to more precisely assess a patient's tumor aggressiveness to help inform clinical decision-making," said Dr. Klein. "Decipher has proven itself a valuable tool for post-prostatectomy patients. This study in a small cohort of patients hints at the potential utility of the test to accurately determine risk of tumor spread for patients at initial diagnosis."
Added Doug Dolginow, M.D., CEO of GenomeDx, "We are pleased by the results of this study and are looking forward to making the benefits of Decipher available to the almost 250,000 men in the US who are diagnosed with prostate cancer every year. We believe the additional information available to patients and physicians with the Decipher GRIDTM will further enable the future of genomic medicine for newly diagnosed men with prostate cancer."
Evaluation of Decipher in 57 patients yielded a c-index of 0.80 for prediction of metastasis at 10 years compared to 0.75 for NCCN risk criteria alone. A combined model consisting of Decipher and NCCN risk criteria improved the accuracy to yield a c-index of 0.88. Multivariable analysis found that Decipher was the only significant predictor of metastasis when adjusting for age, pre-operative PSA and biopsy Gleason score (P = 0.02). These findings demonstrate that Decipher is significantly able to predict metastasis independent of clinical factors in men newly diagnosed with prostate cancer. The additional genomic information provided by Decipher may help identify men who may be optimal candidates for active surveillance or better identify appropriate first-line therapy for men with intermediate disease.
About Decipher® Prostate Cancer Classifier
Decipher® is a genomic test that provides an assessment of tumor aggressiveness and is used by radiation oncologists and urologists to help them determine who to treat and how to treat them in order to offer the most effective and least harmful course of therapy. Decipher offers valuable insight that is distinct from clinical measures of risk including PSA and Gleason score. Studies of thousands of patients from leading cancer centers, published in more than 20 peer-reviewed journals, demonstrate that Decipher can accurately predict metastatic disease, identify patients most likely to benefit from therapeutic intervention, and lead to significant cost-savings for healthcare systems by reducing unnecessary procedures. Decipher is covered by Medicare and multiple private insurance plans in the US representing over 190 million covered lives.
Learn more at www.DecipherTest.com
About Decipher GRID™
The Decipher Genomic Resource Information Database (Decipher GRID™) is the world's largest genomic expression data sharing program in urologic oncology created to enable improvements to precision medicine in patient care. GRID unifies a patient's whole genome data with clinical outcomes from thousands of patients evaluated with Decipher®, providing unprecedented data sharing capabilities. Ultimately, GRID seeks to use patient tumor genomic information to better match an individual to a targeted therapy with the highest likelihood of providing a benefit. The Decipher GRID program is rapidly expanding as major cancer centers partner with GenomeDx to access the database to advance their understanding of urologic cancers through the analysis of large amounts of genomic data.
Learn more at www.DecipherGRID.com
About GenomeDx Biosciences
GenomeDx Biosciences is a genomic information company changing the landscape of urologic cancer patient care with innovative genomic solutions that empower physicians and patients to make more informed decisions about patient treatment. Using advanced cloud-based bioinformatics to mine vast amounts of genomic data, the company develops and commercializes proprietary clinical tests that provide actionable information to answer key clinical questions in patient management. GenomeDx's Decipher® is a genomic test that provides an assessment of tumor aggressiveness and is used by urologists and radiation oncologists to help them determine who to treat and how to treat them in order to offer the most effective and least harmful course of therapy. In collaboration with leading medical centers GenomeDx is building Decipher GRID™, the world's largest genomic expression data sharing program in urologic oncology created to enable improvements to precision medicine in patient care. GenomeDx is based in San Diego, California and Vancouver, British Columbia.
Learn more at www.GenomeDx.com