Prospective Study Shows GenomeDx's Decipher Cancer Classifier Significantly Reclassifies Tumor Aggressiveness

Tuesday, September 6, 2016 Cancer News
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Study Published in Prostate Cancer and Prostatic Diseases

SAN DIEGO, Sept. 6, 2016 /PRNewswire/ -- GenomeDx Biosciences today announced the publication of the first prospective

validation study for its Decipher® Prostate Cancer Classifier test, Decipher Post-Op, a genomic test used to improve clinical decision-making following radical prostatectomy. In the study, Decipher Post-Op reclassified tumor aggressiveness in a large number of patients based on genomic risk assessment, as compared to traditional clinical and pathological risk assessment. These reclassifications have the potential to alter postoperative therapy decisions for patients following prostatectomy by predicting if an individual is at low, intermediate or high risk of tumor metastasis. The study, titled "Decipher correlation patterns post-prostatectomy: initial experience from 2342 prospective patients," was published this month ahead of print in Prostate Cancer and Prostatic Diseases.

"The delivery and timing of postoperative radiation therapy to treat prostate cancer continues to be controversial within the medical community because of ambiguity produced by traditional diagnostic tools," said Robert Den, M.D., associate professor of radiation oncology, cancer biology and urology at Thomas Jefferson University and lead author of the study. "Determining the right patient and the right time for postoperative radiation therapy is not straightforward. Patients and physicians have to balance the potential complications from radiation treatment with the risk of prostate cancer recurring. This study emphasizes the importance of utilizing a genomic classifier score, such as Decipher, to reclassify patients and better stratify postoperative therapy decisions, allowing for increased personalization of patient management."

The study included de-identified Decipher test results from 2,342 radical prostatectomy patients tested between January and September 2015. The samples were analyzed for genomic risk through Decipher, as well as clinically through CAPRA-S, a standard risk model used to evaluate cancer recurrence after surgery. While Decipher correlated with baseline tumor characteristics for more than 2,000 patients, there was significant reclassification of tumor aggressiveness as compared to clinical parameters alone.  Specifically, Decipher reclassified 52%, 76% and 40% of patients in CAPRA-S low, intermediate and high-risk groups, respectively, demonstrating that utilization of the Decipher genomic classifier can have major implications in assessment of postoperative risk.  Previous studies of Decipher have shown that Decipher is highly accurate in detecting tumors with the greatest potential to metastasize, confirming the value of reclassifying patients' risk based on genomic information and selecting therapy accordingly.

"This study demonstrates, in a robust cohort of patients, that the use of Decipher can provide both the patient and physician with a more accurate classification of low, intermediate and high risk of tumor aggressiveness, compared to clinical measures alone," said Doug Dolginow, M.D., chief executive officer of GenomeDx. "We believe this will lead to more informed postoperative treatment recommendations and allow for better personalization of therapy."

About Decipher® Prostate Cancer Classifier TestsOur Decipher Prostate Cancer Classifier tests are currently comprised of Decipher Biopsy and Decipher Post-Op. These commercially available genomic tests provide an assessment of tumor aggressiveness based on the patient's unique genomic profile. Decipher Biopsy is indicated for men with localized prostate cancer after biopsy diagnosis and Decipher Post-Op is indicated for men after prostate removal surgery. The Decipher tests are used by physicians to stratify patients into more accurate risk groups to better determine which patients will likely benefit from additional treatment and which will not, thereby enabling improved decision-making and helping low-risk patients avoid unnecessary treatments that have serious adverse side effects and result in unnecessary costs to the healthcare system. Studies of thousands of patients from leading cancer centers, published in multiple peer-reviewed journals, demonstrate that the Decipher tests can more accurately predict disease aggressiveness than traditional clinical measures, such as PSA and Gleason score. Decipher Post-Op is covered by Medicare and by a number of private payors and preferred provider organizations representing, together with Medicare, about 70% of the approximately 66 million adult men in the United States age 40 or older who are at increased risk of being diagnosed with prostate cancer.

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About Decipher GRID®Our Decipher Genomics Resource Information Database (Decipher GRID) is a genomic expression database that provides a foundation for open and interactive research collaboration and knowledge creation. Decipher GRID is a rapidly growing database that contains genomic profiles of thousands of patient tumors, and constitutes what we believe to be the world's largest shared, clinically-annotated genomic expression database in urologic cancer as well as one of the world's largest global RNA expression databases utilizing cloud-based analytics. We believe Decipher GRID gives rise to new opportunities for information technology-enabled genomic solutions and enables us to more rapidly discover, develop, commercialize and drive the adoption of our existing and new genomic tests. Through Decipher GRID, GenomeDx is building a suite of genomic tests in urologic cancer that we believe will allow us to achieve our goals of reducing costs to the healthcare system and improving patient lives, from screening through late-stage therapy.    

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About GenomeDx BiosciencesGenomeDx Biosciences uses the power of collaborative genomics to transform the management and treatment of cancer patients. GenomeDx has built Decipher GRID, a large genomics database in urologic cancer that provides a foundation for open and interactive research collaboration and knowledge creation. Using Decipher GRID 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 both traditional diagnostic tools and existing genomic tests. GenomeDx's Decipher Biopsy and Decipher Post-Op are commercially available prostate 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 has offices in San Diego, California.

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SOURCE GenomeDx Biosciences

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