GenomeDx's Decipher Prostate Cancer Classifier Accurately Predicts Metastasis Ten Years after Prostate Removal in Study Published by European Urology
SAN DIEGO, June 25, 2015 /PRNewswire/ -- GenomeDx Biosciences today announced that a study published in European Urology showed that its Decipher® Prostate Cancer Classifier maintained accurate prediction of metastasis in patients up to ten years after prostate surgery. The study, titled "Tissue-based Genomics Augments Post-prostatectomy Risk Stratification in a Natural History Cohort of Intermediate- and High-Risk Men," was published online this month ahead of print in the June 2015 issue of European Urology.
The study, conducted at Johns Hopkins Hospital, is the longest follow-up study to date with Decipher and was evaluated in 260 men who did not receive additional treatment until metastasis following prostate surgery. At 10 years after prostate surgery, the cumulative incidence of metastasis was 12%, 31%, and 47% (p < 0.01) among patients with low, intermediate, and high Decipher scores, respectively. Decipher was independently prognostic of metastasis in multivariable analysis (hazard ratio 1.26 per 10% increase; p < 0.01). In combination with standard risk models such as CAPRA-S, Decipher further improved prediction of metastasis (AUC 0.87) at 10 years after prostate surgery.
"In our earlier studies, we have repeatedly seen that Decipher is accurate in predicting tumor metastasis up to five years after prostate surgery," said Elai Davicioni, Ph.D., president and chief scientific officer at GenomeDx and an author on the study. "With this longer follow-up in a robust cohort of treatment-naive patients, investigators at Johns Hopkins have demonstrated that Decipher is highly predictive of tumor metastasis in the ten year period following prostate surgery, and that its ability to maintain its performance is not impacted by treatment. These are important findings for clinicians and patients making decisions about the best course of treatment after surgery."
"The findings from this study are significant and suggest that use of genomic testing such as Decipher may help us make better informed decisions about appropriate utilization of therapy," said Edward Schaeffer, M.D., associate professor or urology, oncology & pathology and director of the prostate cancer program at the James Buchanan Brady Urological Institute at Johns Hopkins Medical Center. "The long term follow-up in this study gives us increased confidence that Decipher can provide independent information to guide decision-making for men after prostate surgery."
The commercially available Decipher Prostate Cancer Classifier is covered by Medicare and evaluates 22 genomic markers to accurately and independently predict metastatic onset after radical prostatectomy for patients with adverse pathology. The Decipher test was developed by interrogating billions of genomic data points collected from clinical studies published in over 20 peer-reviewed articles. That foundational genomic database also serves as the basis for Decipher GRIDTM, GenomeDx's clinical genomics registry data sharing program, which was launched last month. Genomic information collected through Decipher GRID enables more personalized genomic insights for major cancer centers and community-based urology practices participating in the program.
About Decipher® Prostate Cancer Classifier
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.
Learn more at: www.DecipherTest.com and follow Decipher on Twitter @DecipherTest and on Facebook.
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 20 years of prostate cancer research expertise. 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.
Learn more at www.genomedx.com and follow us on Twitter at @GenomeDx, Facebook, LinkedIn and YouTube.
Media Contact:
Ian Stone
Canale Communications
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SOURCE GenomeDx Biosciences
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