Healthcare Industry News:  GenomeDx Biosciences 

Diagnostics Oncology

 News Release - February 4, 2016

GenomeDx Publishes First Study Supporting Use of Decipher Test in Prostate Biopsy

Company's Proprietary Genomic Classifier Demonstrates Unprecedented Accuracy in Diagnostic Biopsies
Study Published in Urology

SAN DIEGO, Feb. 4, 2016 -- (Healthcare Sales & Marketing Network) -- GenomeDx Biosciences today announced publication of results that show Decipher Prostate Cancer Classifier, which is validated and commercially available for patients following prostate surgery, can also predict the risk of metastasis and high-grade disease at the time of biopsy. These results, currently available online and anticipated to be published in the April 2016 issue of Urology, are part of a study conducted by the Cleveland Clinic Foundation. This is the first validation study that demonstrates the potential of the Decipher test to be used for prostate cancer patients after biopsy. In this study, investigators found that the same cohort of samples that previously demonstrated the clinical validation of Decipher to predict the risk of metastasis after radical prostatectomy (RP) also possess a similar predictive ability when measured on diagnostic biopsies.

The findings provide compelling evidence for the capability for the Decipher platform to use diagnostic prostate needle biopsies to predict the risk of high-grade disease and metastasis at 5 and 10 years post RP. Fifty-seven patients with available biopsy specimens were analyzed from a cohort of men treated with RP in a previously reported Decipher validation study at Cleveland Clinic. The median follow-up for these patients was eight years, and Decipher was compared to standard clinical measures as well as reviewed in combination to better understand the predictive value of the classifier at the time of biopsy.

"We are continually looking for new and novel clinical aids to help us classify patient risk in the overall spectrum of care of patients with prostate cancer," said Eric Klein, M.D., Head of the Glickman Urological and Kidney Institute at Cleveland Clinic. "Biopsy-based Decipher outperformed NCCN (National Comprehensive Cancer Network) clinical risk, biopsy Gleason score, and preoperative PSA in terms of predictive value. Importantly, combining Decipher with NCCN clinical risk further increased the concordance index from 0.80 for Decipher alone to 0.88. Furthermore, Decipher showed predictive value for low, intermediate, and high risk patients in this small study, which if held up across larger cohorts, would be a powerful tool to help stratify risk across prostate cancer patients at the biopsy stage."

"We are extremely fortunate to collaborate with the team at Cleveland Clinic to further demonstrate the power of the Decipher platform," stated Elai Davicioni, President and Chief Scientific Officer at GenomeDx Biosciences. "The Decipher Prostate Cancer Classifier continues to deliver unrivaled performance in both biopsy and surgical tissue specimens. Ongoing validation studies with top institutions are investigating the utility of Decipher in thousands of patients at initial diagnosis across all stages of the disease and we are excited to share the results from these larger cohorts in the near future. We are honored to work with the community of Decipher users, such as the investigators at the Cleveland Clinic, to improve the lives of men with prostate cancer and to show the power of data sharing and collaborative research to further our understanding of this fundamentally genomic 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.

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About Decipher GRID™

The Decipher Genomic Resource Information Database (Decipher GRID™) was created to enable improvements to precision medicine in patient care and represents what we believe is the world's largest clinically-annotated genomic expression database in urologic oncology. 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.

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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, GenomeDx 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. GenomeDx is based in San Diego, California and Vancouver, British Columbia.

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Source: GenomeDx Biosciences

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