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GenomeDx Launches Decipher Bladder Cancer Classifier Following Publication of Study on Development, Validation of Molecular Subtyping in Muscle-Invasive Bladder Cancer Patients

Company’s Proprietary Genomic Technology to Guide Treatment of Aggressive Bladder Cancer

Study Published in European Urology

San Diego – May 10, 2017 – GenomeDx Biosciences today announced the launch of its Decipher® Bladder Cancer Classifier (Decipher Bladder) following the publication of a study supporting its development and validation. GenomeDx believes that Decipher Bladder is the first commercially available clinical assay to subtype muscle invasive bladder cancer (MIBC) with a high degree of accuracy. The study, “Impact of molecular subtypes in muscle-invasive bladder cancer on predicting response and survival outcome to neoadjuvant chemotherapy,” was published online ahead of print in European Urology.

“We believe that Decipher Bladder is the first commercially available genomic test available for muscle invasive bladder cancer patients facing very challenging decisions around their care,” said Doug Dolginow, M.D., chief executive officer of GenomeDx. “We believe that use of genomic information will be essential for all patients with MIBC and are excited to see further results from our ongoing studies of Decipher and the GRID genome-wide expression analysis that support the utility of genomics in this underserved population.”

Molecular subtyping of MIBC may be used to better prioritize patients diagnosed with aggressive bladder cancer to pursue underutilized standard of care chemotherapy before bladder removal surgery. MIBC is a high-grade bladder tumor that has significant risks of recurrence, metastasis and death. The standard treatment for these patients is neo-adjuvant chemotherapy (NAC) followed by radical cystectomy. Suboptimal response rates to chemotherapy and the associated burden of cisplatin-based treatment underscore the need to develop new tools to help better identify patients who may benefit most from chemotherapy.

The prospectively designed retrospective study enrolled 343 patients with MIBC treated at seven institutions from Canada, Europe and the United States. Using the Decipher assay, the samples were classified with a high degree of accuracy (AUC >0.85) according to four consensus subtypes proposed by the University of North Carolina, The Cancer Genome Atlas project and other leading MIBC research groups. In 305 evaluable patients, the study validated the previous findings that patients with favorable prognosis luminal tumors had the best overall survival, irrespective of treatment regimen, while basal tumors showed a nearly 30% improvement in overall survival with NAC compared to surgery alone and should be prioritized for treatment.

“Despite evidence demonstrating a survival benefit of NAC in MIBC, uptake remains low. Use of Decipher to identify bladder cancer subtypes with the most to gain from chemotherapy may help improve its utilization in clinical practice,” said Peter Black M.D., associate professor at the University of British Columbia, and lead investigator of this study. “Decipher genome-wide RNA expression analysis has great potential as a tool to help us better treat patients and continue our research of bladder cancer that we believe will benefit future patients as well.”

About Decipher GRID® and Cancer Classifier Tests

GenomeDx’s Decipher Genomics Resource Information Database (GRID) contains genomic profiles of thousands of tumors from patients with urological cancers, and is believed by GenomeDx to be the largest shared genomic expression database in urologic cancer as well as one of the world’s largest global RNA expression databases using cloud-based analytics. GRID is a platform for interactive research collaboration, and may enable more rapid discovery, development, commercialization and adoption of new genomic solutions for key clinical questions in cancer treatment.

Derived from GRID, GenomeDx’s Decipher Prostate and Bladder Cancer Classifier tests are commercially available genomic tests that provide a genomic assessment of tumor aggressiveness for individual patients. Decipher Biopsy is indicated for men with localized prostate cancer at diagnosis, Decipher Post-Op is indicated for men after prostate removal surgery and Decipher Bladder is indicated for patients being considered for neoadjuvant chemotherapy prior to bladder removal surgery. The Decipher tests are used by physicians to stratify patients into more accurate risk groups than determined by traditional diagnostic tools and to better determine which patients may be more likely to benefit from additional treatment. Each tumor analyzed with a Decipher test adds new data points to the GRID database, which is compiled into a Decipher GRID Profile that may reveal additional biological characteristics of the tumor for ongoing research purposes. Going beyond risk stratification, Decipher and GRID makes accessible genetic information for researchers to potentially better predict responses to therapy and more precisely guide treatment.

More information is available at www.deciphertest.com and www.deciphergrid.com

About GenomeDx Biosciences

GenomeDx has reimagined the use of genomics as a platform for mass collaboration to improve treatment and outcomes of people with cancer. GenomeDx has built Decipher GRID, a large and fast-growing genomics database in urologic cancer that provides a foundation for open and interactive research collaboration and knowledge creation. Using Decipher GRID and machine learning 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 traditional diagnostic tools or existing genomic tests. GenomeDx’s Decipher Biopsy, Decipher Post-Op and Decipher Bladder are commercially available urologic 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 operates a clinical laboratory in San Diego, California.

Learn more at www.GenomeDx.com

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