SAN DIEGO, May 28, 2015 /PRNewswire/ -- GenomeDx Biosciences today announced the publication of a multi-institutional validation study titled "Characterization of 1,577 primary prostate cancers reveals novel biological and clinicopathologic insights into molecular subtypes." The study demonstrates the ability of its newly launched Decipher GRID (genomics resource information database) to accurately determine the status of molecular or 'intrinsic' subtypes of prostate cancer, including ERG, a well-documented biomarker correlated with prostate cancer progression and resistance to certain therapeutics.
The study, published online this month in European Urology, looked at genome-wide transcription of 1,577 low, intermediate and high risk patients from eight different US and international cancer centers profiled with the Decipher test and bioinformatics platform. The study showed that Decipher performed consistently across all the subtypes evaluated and most notably, demonstrated that the platform was able to determine ERG status with 95% accuracy when compared to testing by FISH (Florescent in situ hybridization), the current gold standard for evaluating ERG.
The biomarkers evaluated in this study, including ERG, ETV1, ETV4, ETV5, FLI1 and SPINK1 are now being offered as standard, along with others, through the Decipher GRID, a research-based data sharing platform and program that was launched earlier this month. As additional data are added to the Decipher GRID they can eventually be used to systematically study large populations of patients to help us redefine our understanding of the biology of prostate and other urologic cancers.
"The findings from this study are important since we know that men with prostate cancer harbor multiple genetically independent tumor clones that may have variable morphology such as Gleason score," said Scott A. Tomlins M.D., Ph.D., Assistant Professor of Urology and Pathology, University of Michigan Medical School. "That means we may be able to use this technology to profile multiple foci at surgery or biopsy to directly assess the impact of true multi-focality on the Decipher prognostic result or other prognostic signatures. Likewise, as the subtyping is generated from the same data generated as part of the Decipher prognostic test, there isn't a need to run two different assays to get this information."
The commercially available Decipher Prostate Cancer Classifier is covered by Medicare and evaluates 22 genomic markers to accurately & independently predict metastatic onset after radical prostatectomy. The Decipher test was developed by interrogating billions of genomic data points collected from clinical studies published in 20 peer-reviewed articles. The University of Michigan led study highlights the potential of this rich clinical genomic resource (known as Decipher GRID), which has been developed by GenomeDx in collaboration with leading cancer centers.
"This study showed us that Decipher can measure the expression of multiple known clonal markers that may be important to our understanding of prostate cancer heterogeneity," said Elai Davicioni Ph.D., President and Chief Scientific Officer at GenomeDx Biosciences. "These results are exciting because they show we can provide additional data for users of the Decipher GRID that may be of impact to men after an initial diagnosis of cancer with a prostate biopsy."
Incorporation of intrinsic subtypes into a clinically available prognostic assay has several areas of potential near-term clinical utility including offering predictive biomarkers for systemic therapy. In the immediate future, providing transcriptomic profiles for tens of thousands of patients could help further precise and personalized treatment decisions with more targeted approaches.
The Decipher® Prostate Cancer Classifier is a highly validated and commercially available genomic test for men with intermediate and high risk prostate cancer. Decipher predicts cancer aggressiveness by looking for a unique genomic signature comprised of a validated series of biomarkers associated with metastatic disease. Adding truly unique information to the treatment decision-making process, Decipher generates a risk result that is completely independent and distinct from PSA, Gleason score and other clinical risk factors. Clinical studies from leading cancer centers published in over a dozen medical journals demonstrate that Decipher can accurately predict metastatic disease, which men may benefit from radiation therapy following prostate surgery, and can lead to significant cost-savings for healthcare systems. Decipher was developed in partnership with the Mayo Clinic.
Decipher is covered by Medicare and multiple private insurance plans and is available to eligible US patients through their physicians.
About Decipher GRIDTM
The Decipher Genomic Research Information Database (GRIDTM) is the world's largest clinically annotated urologic cancer genomic expression database, built up over 8 years of global research with thousands of patients studied using the Decipher test platform. Data sharing through Decipher GRID provides clinicians and cancer centers & an innovative opportunity to translate advances in genomics to individualize the care of patients suffering from urologic cancers. The ability to mine the GRID for genomic insights may help identify more appropriate treatment strategies or selection for clinical trials of novel agents for patients at the highest risk of disease progression.
Learn more at: www.DecipherGRID.com
About GenomeDx Biosciences
GenomeDx Biosciences is focused on transforming cancer patient care by putting usable genomic information in the hands of patients and their physicians. GenomeDx is developing and commercializing Decipher®, a highly validated genomic test for predicting metastatic disease in men with prostate cancer. In partnership with leading medical centers, the company has assembled the largest genomic catalogue of prostate cancer tumors in the world, representing billions of data points and more than 30 years of prostate cancer clinical experience. Using advanced cloud-based bioinformatics, GenomeDx mines the genomic data to develop proprietary tests that address key clinical questions in cancer patient management. GenomeDx has partnered to share genomic data with leading clinician-scientists worldwide to collaboratively enrich the knowledge and understanding of urologic cancers for the goal of improving global cancer patient care. GenomeDx is based in San Diego, California and Vancouver, British Columbia.
University of Michigan Health System Conflict of Interest Notice
The University of Michigan has been issued a patent on the detection of ETS gene fusions in prostate cancer on which Dr. Tomlins is listed as a co-inventor. The University of Michigan licensed the diagnostic field of use to Hologic/Gen-Probe Inc., which sublicensed some rights to Ventana Medical Systems. Dr. Tomlins has received Honoria from and served as a consultant to Ventana.
SOURCE GenomeDx Biosciences