Studies Published in the Journal of Clinical Oncology and European Urology
San Diego – June 7, 2017 – GenomeDx Biosciences, a leader in the field of urologic cancer genomics, today announced results from three recent publications demonstrating the clinical validity of the Decipher® Prostate Cancer Classifier (Decipher Post-Op), a commercially available genomic test for men with prostate cancer following radical prostatectomy (RP). Collectively, the new data highlight the ability of Decipher Post-Op to predict disease aggressiveness, enabling physicians to stratify the patient into more accurate risk groups and better determine which patients will likely benefit from additional treatment and which will not. The studies have been published in the Journal of Clinical Oncology and European Urology, respectively.
“We have demonstrated across numerous clinical publications that Decipher Post-Op is one of the only commercially available genomic tests developed for men following RP that can consistently outperform traditional clinical measures,” said Doug Dolginow, M.D., chief executive officer of GenomeDx. “Despite the strong prognostic value of Gleason score, stage, and PSA in men who have undergone RP, there remains considerable variability in risk of dying from, rather than with, prostate cancer. Decipher Post-Op provides physicians with critical genomic information to aid in treatment decisions and allow for better personalization of therapy.”
The study, “Individual Patient-Level Meta-Analysis of the Performance of the Decipher Genomic Classifier in High-Risk Men After Prostatectomy to Predict Development of Metastatic Disease,” was published online ahead of print in Journal of Clinical Oncology. The study performed the first meta-analysis of the performance of Decipher Post-Op in men following RP and included a total of 855 patients across five studies. Results showed that Decipher further improved prediction of metastasis (AUC 0.81) at 10 years after prostate surgery versus the clinical model alone.
Further demonstrating the clinical validity of Decipher Post-Op, the study, “Genomic Classifier Augments the Role of Pathological Features in Identifying Optimal Candidates for Adjuvant Radiation Therapy in Patients With Prostate Cancer: Development and Internal Validation of a Multivariable Prognostic Model,” was also published online ahead of print in Journal of Clinical Oncology. The purpose of the study was to develop a risk stratification tool incorporating the Decipher score, along with routinely available clinicopathologic features to identify which patients would benefit the most from adjuvant radiation therapy (ART). The cohort included 512 prostate cancer patients treated with RP at multiple institutions between 1990-2010. Results showed that incorporating Decipher added prognostic value in identifying patients with adverse pathologic features, which might reduce overtreatment, decrease unnecessary adverse effects, and reduce risk of clinical recurrence in the subset of prostate cancer patients who benefit from ART.
The clinical validity of Decipher Post-Op was also featured in the study, “Validation of a Genomic Risk Classifier to Predict Prostate Cancer Specific Mortality in Men with Adverse Pathologic Features,” published online ahead of print in European Urology. The multi-institutional study included 561 men at intermediate and high risk for prostate cancer progression that underwent RP between 1987-2010, and demonstrated the ability Decipher Post-Op to predict likelihood of prostate cancer specific mortality in patients ten years after their prostate surgery, independent of standard risk models.
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.
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