GenomeDx, Mayo Clinic to Conduct Validation Study of Decipher® Prostate Cancer Test
Builds on initial collaboration with Mayo Clinic that led to the development and commercialization of Decipher in patients following prostate surgery
GenomeDx Biosciences today announced that the company has expanded its research agreement with Mayo Clinic to initiate a validation study to expand the use of the Decipher® Prostate Cancer Classifier, a genomic test capable of predicting metastatic prostate cancer, for use in prostate biopsy specimens. The outcome of the study, if successful, is expected to support the application and utility of the Decipher test in patients receiving biopsy.
“Our past research on the Decipher prostate cancer test has helped build an understanding of the important role that a genomic test plays in managing the treatment of high-risk men after surgery,” says R. Jeffrey Karnes, M.D., associate professor and vice chair in Urology at Mayo Clinic and principal investigator on the study. “With this new study, we can now further our understanding of how genomics may be applied in other prostate cancer populations.”
“Mayo Clinic maintains the most comprehensive cohort of samples associated with well-curated clinical and outcomes data from patients classified as high risk for metastatic disease,” says Doug Dolginow, M.D., chief executive officer of GenomeDx. “Both parties have a commitment to developing transformative genomic tools for predicting aggressiveness of prostate cancer. This naturally evolving collaboration with Mayo Clinic is essential to further establish the potential of Decipher in patients with different stages of prostate cancer.”
The study is the result of research conducted by the Mayo Clinic Departments of Urology and Laboratory Medicine and Pathology. The study will be managed by Mayo Validation Support Services, which will serve as the collaboration liaison for the Mayo investigators while facilitating access to Mayo Clinic biospecimen resources and clinical information.
GenomeDx and Mayo Clinic previously expanded their agreement in April 2013 to include an exclusive license to certain co-developed and Mayo-developed intellectual property. This new agreement includes continued access to the clinical data concerning Mayo Clinic’s cohort of prostate cancer samples to allow for longer term follow-up and evaluation of biomarkers. The initial collaboration, entered in 2009, led to the development, validation, and commercialization of the Decipher Prostate Cancer Classifier for use in high-risk men following radical prostatectomy (prostate surgery). Decipher has already been validated in 10 peer-reviewed published studies, all work that was initiated with that initial Mayo collaboration.
GenomeDx recently announced that Palmetto GBA, the Medicare administrative contractor, issued a draft local coverage determination (LCD) for Decipher for men who have undergone radical prostatectomy. Once finalized the LCD will establish coverage for Medicare beneficiaries throughout the United States.
Mayo Clinic has a financial interest in the technology referenced in this news release.
The Decipher® Prostate Cancer Classifier directly measures a patient’s biological risk of developing metastatic prostate cancer. By assessing the activity of multiple genomic markers associated with metastatic disease, Decipher provides information about the aggressiveness of a patient’s tumor — information distinct from that provided by PSA and other clinical risk factors. Decipher continues to demonstrate that it can accurately predict aggressive disease and help physicians make more informed treatment decisions for men with prostate cancer.
Decipher is covered by multiple private insurance plans and is available to eligible U.S. patients through their physicians. To learn more about ordering the Decipher test, please visit www.deciphertest.com.
About GenomeDx Biosciences
GenomeDx Biosciences is focused on transforming patient management by putting usable genomic information in the hands of patients and their physicians. GenomeDx has developed the Decipher® Prostate Cancer Classifier, the first and only commercially available genomic test that predicts the risk of developing metastatic prostate cancer independently of PSA and other conventional risk-assessment tools. GenomeDx is based in San Diego, California, and Vancouver, British Columbia. To learn more, visit www.genomedx.com.
About Mayo Medical Laboratories and the Mayo Clinic Department of Laboratory Medicine and Pathology
Mayo Medical Laboratories is the largest for-profit company associated with Mayo Clinic, the world-renowned health care organization located in Rochester, Minnesota. MML is the third-largest provider of esoteric laboratory services in the United States and serves more than 4,000 clients in 130 countries. Mayo Clinic's Department of Laboratory Medicine and Pathology maintains an active diagnostic test-development program. These activities also incorporate technologies from collaborations with diagnostic and biotechnology companies. Mayo Clinic utilizes these proven diagnostic technologies in the care of its patients and offers them to health care institutions through Mayo Medical Laboratories. Revenue from this testing is used to support medical education and research at Mayo Clinic.
Mayo Clinic is a nonprofit worldwide leader in medical care, research, and education for people from all walks of life. For more information, visit mayoclinic.com or mayoclinic.org/news. Journalists can become a member of the Mayo Clinic News Network for the latest health, science, and research news and access to video, audio, text, and graphic elements that can be downloaded or embedded.