GenomeDx's Decipher Platform Utilizes Gene Expression Signatures to Predict Lymph Node Metastasis in Bladder Cancer Patients

SAN DIEGO, June 14, 2016 /PRNewswire/ -- GenomeDx Biosciences today announced that its Decipher GRID^TM platform was used to develop and validate a novel genomic signature, known as KNN51, for the prediction of lymph node involvement at the time of radical cystectomy in patients with muscle-invasive bladder cancer (MIBC). Lymph node involvement is a known risk factor warranting intensification of therapy, however it is missed in up to approximately 25% of cases. Researchers indicated that more accurate detection and classification of disease with this genomic signature may potentially guide patient therapy earlier in the disease. The study was published online ahead of print in The Journal of Urology.

Patients with lymph node involvement in their disease have historically been shown to be at a high risk for disease recurrence and death. These patients have demonstrated improved outcomes by treatment intensification with neoadjuvant chemotherapy (NAC). However, current clinical staging misses up to approximately 25% of these high-risk cases due to sensitivity limitations with imaging techniques and rudimentary clinical risk assessment tools. The ability to pre-operatively predict patient response to NAC would allow for optimal patient management. The data demonstrate that this newly developed gene signature is clinically superior to previously described gene signatures, and if validated prospectively, could be used to guide high-risk patients to early multimodal therapy.

"Decipher GRID has proven to be a powerful tool for identifying powerful genetic markers that are predictive of aggressive disease, and a more accurate tool than existing methods for characterizing patient risk," said Doug Dolginow, M.D., chief executive officer of GenomeDx. "The identification of new genomic solutions that can be applied towards patients suffering from bladder cancer, such as KNN51, is another step forward towards improving outcomes in this underserved patient population. We look forward to continuing to validate this genomic solution in bladder cancer, and expect to bring Decipher Bladder to market in early 2017."

The study included 199 patients that underwent radical cystectomy with extended pelvic lymphadenectomy at the University of Southern California between 1998 and 2004.  Whole transcriptome expression profiles were generated on all patients. The cohort was divided randomly into a discovery (n=133) and a validation set (n=66). In the discovery set, features were identified and modeled into a classifier (KNN51) for prediction of pathologic lymph node metastases. Two previously described bladder cancer gene signatures, the 15-gene cancer recurrence signature (RF15) and 20-gene lymph node signature (LN20) were also modeled in the discovery set for comparison.

In the validation set, KNN51 predicted lymph node involvement with high discrimination and significantly outperformed RF15 and LN20. In addition, only KNN51 was significant in predicting the odds of lymph node metastasis whereas both RF15 and LN20 were not significant predictors of lymph node metastasis in this study.

About Decipher® Bladder Cancer Classifier Tests
Our first Decipher bladder cancer classifier tests are currently under development with a goal of providing an assessment of tumor aggressiveness based on the patient's unique genomic profile. We believe these tests may be used by physicians to stratify patients into more accurate risk groups to better determine which patients will likely benefit from additional treatment and which will not, thereby enabling improved decision-making and helping low-risk patients avoid unnecessary treatments that have serious adverse side effects and result in unnecessary costs to the healthcare system. GenomeDx is currently validating its lead bladder cancer test through clinical studies and plans to launch it commercially in early 2017.

About Decipher GRID^TM
Our Decipher Genomics Resource Information Database (Decipher GRID) is a genomic expression database that provides a foundation for open and interactive research collaboration and knowledge creation. Decipher GRID is a rapidly growing database that contains genomic profiles of thousands of patient tumors, and constitutes what we believe to be the world's largest shared, clinically-annotated genomic expression database in urologic cancer as well as one of the world's largest global RNA expression databases utilizing cloud-based analytics. We believe Decipher GRID gives rise to new opportunities for information technology-enabled genomic solutions and enables us to more rapidly discover, develop, commercialize and drive the adoption of our existing and new genomic tests. Through Decipher GRID, GenomeDx is building a suite of genomic tests in urologic cancer that we believe will allow us to achieve our goals of reducing costs to the healthcare system and improving patient lives, from screening through late-stage therapy.    

Learn more at www.DecipherGRID.com

About GenomeDx Biosciences
GenomeDx Biosciences uses the power of collaborative genomics to transform the management and treatment of cancer patients. GenomeDx has built Decipher GRID, a large genomics database in urologic cancer that provides a foundation for open and interactive research collaboration and knowledge creation. Using Decipher GRID to analyze vast amounts of genomic data, GenomeDx develops and commercializes proprietary clinical tests that are intended to provide more accurate and useful diagnostic information than both traditional diagnostic tools and existing genomic tests. GenomeDx's Decipher Biopsy and Decipher Post-Op are commercially available prostate cancer genomic tests that provide an assessment of tumor aggressiveness based on a patient's unique genomic profile. GenomeDx is headquartered in Vancouver, British Columbia and has offices in San Diego, California.

Learn more at www.GenomeDx.com

SOURCE GenomeDx Biosciences

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