San Diego, August 4, 2015 – GenomeDx Biosciences announced today that its commercially-available Decipher® testing platform identified, with statistical significance, a set of prostate cancer biomarkers predictive of aggressive disease in African American men after radical prostate surgery. This represents the first and only study describing a set of genomic markers that have the ability to predict tumor aggressiveness in a race-dependent manner. Additionally, the study demonstrated that the Medicare covered Decipher test is an independent predictor of metastasis in African American men. The study, titled “Novel Biomarker Signature That May Predict Aggressive Disease in African American Men with Prostate Cancer,” was published this month online ahead of print in the latest issue of the Journal of Clinical Oncology.
“African American men have historically experienced a higher incidence of mortality from prostate cancer than men of other races and ethnicities, and clinicians have long sought a better understanding of what drives this more aggressive disease,” said Kosj Yamoah, M.D., Ph.D., Assistant Professor in Radiation Oncology, Genitourinary Program Moffitt Cancer Center & Research Institute. “The ability to identify a subset of African American men who harbor aggressive disease will enable clinicians to more accurately identify appropriate treatments to enhance disease control and ultimately help to improve outcomes in this patient population.”
The study, which included 154 African American and 243 European American patient samples pulled from the Decipher Genomics Resource Information Database (GRID), evaluated 20 validated biomarkers reported to be associated with prostate cancer initiation and progression. Of 20 biomarkers examined, six showed statistically significant differential expression in African American men compared with European American men. The results suggest that prostate cancer may arise from distinct molecular pathways in European men compared to African American men. The uniqueness in the biology and evolution of prostate cancer in African American men may have clinical implications for applications in both diagnostics and therapeutics.
“These biomarkers provide a source of relevant knowledge in developing a signature that may be unique to African American men with aggressive prostate cancer, and also provide new insights about the relationship between tumor biology and the racial disparity in prostate cancer outcomes,” said Elai Davicioni, Ph.D., president and chief scientific officer at GenomeDx and an author on the study. “This study evaluated a number of biomarkers that were shown to predict risk of high stage disease in a race-dependent manner, but also validated that Decipher can accurately and independently predict metastasis within 5 years after prostatectomy in African American men (AUC = 0.78).”
Complete results are provided in the study published by the Journal of Clinical Oncology.
The Decipher® Prostate Cancer Classifier is a highly validated and commercially available genomic test for men with intermediate and high risk prostate cancer. Decipher predicts cancer aggressiveness by looking for a unique genomic signature comprised of a validated series of biomarkers associated with metastatic disease. Adding truly unique information to the treatment decision-making process, Decipher generates a risk result that is completely independent and distinct from PSA, Gleason score and other clinical risk factors. Clinical studies from leading cancer centers published in over a dozen medical journals demonstrate that Decipher can accurately predict metastatic disease, which men may benefit from radiation therapy following prostate surgery, and can lead to significant cost-savings for healthcare systems. Decipher was developed in partnership with the Mayo Clinic.
Decipher is covered by Medicare and multiple private insurance plans in the US.
About GenomeDx Biosciences
GenomeDx Biosciences is focused on transforming cancer patient care by putting usable genomic information in the hands of patients and their physicians. GenomeDx is developing and commercializing Decipher®, a highly validated genomic test for predicting metastatic disease in men with prostate cancer. In partnership with leading medical centers, the company has assembled the largest genomic catalogue of prostate cancer tumors in the world, representing billions of data points and more than 20 years of prostate cancer research expertise. Using advanced cloud-based bioinformatics, GenomeDx mines the genomic data to develop proprietary tests that address key clinical questions in cancer patient management. GenomeDx has partnered to share genomic data with leading clinician-scientists worldwide to collaboratively enrich the knowledge and understanding of urologic cancers for the goal of improving global cancer patient care. GenomeDx is based in San Diego, California and Vancouver, British Columbia.
Complementing the specificity of the Decipher test is the Decipher Genomic Research Information Database (GRID™); the world’s largest accessible, urologic cancer genomic expression database formed from more than eight years of global research with thousands of patients studied on the Decipher test platform. Through partnerships with major cancer centers to develop clinical genomic registries, GenomeDx is rapidly expanding Decipher GRID. The development of this large and growing knowledgebase serves as a hub to drive R&D and unlock new insights into the biology urologic cancers. Learn more at: www.DecipherGRID.com
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