GenomeDx's Decipher Post-Op Demonstrates Positive Impact on Physician, Patient Treatment Decisions in Multicenter Prospective Study

SAN DIEGO, April 25, 2017 /PRNewswire/ -- GenomeDx Biosciences today announced the publication of interim results from an ongoing prospective clinical study of the impact of the Decipher® Prostate Cancer Classifier Post-Op test (Decipher test) on physician and patient decision making after prostate surgery. The interim results showed that knowledge of Decipher test results was associated with a change in both physician and patient treatment decisions, as well as improved decision effectiveness for men with prostate cancer considering adjuvant radiation therapy (ART) or salvage radiation therapy (SRT) after radical prostatectomy (RP). The article, titled "Decipher Test Impacts Decision-Making among Patients Considering Adjuvant and Salvage Treatment following Radical Prostatectomy: Interim Results from the Multicenter Prospective PRO-IMPACT Study," was published online this month ahead of print in the journal Cancer.

Approximately 50% of patients will have one or more adverse tumor pathology features after prostate cancer surgery and will be at increased risk of recurrence, metastasis and death. In these men, a multi-modal treatment is often followed by combining surgery with radiation, and either with or without hormone therapy. While known to improve health outcomes, multi-modal therapy poses potential significant harm to the patient's quality of life, including impeding sexual and urinary functional recovery. The Decipher test provides a genomic assessment of the aggressiveness of the patient's tumor, and is used by physicians to determine the need for and timing of additional therapy after surgery.

"Making additional treatment decisions for men with adverse pathology after surgery is difficult. Prior to the development of genomic assessment for prostate cancer patients, there was a lot of uncertainty around which patients might benefit from postoperative radiation and when to begin treatment," said John Gore. M.D., M.S., Associate Professor of Urology at the University of Washington and Seattle Cancer Care Alliance. "This study demonstrates that Decipher is important to guiding the shared decisions physicians and patients need to make after surgery and provides more confidence in those decisions.  We have now completed the trial and look forward to the final study analyses to determine whether the treatment recommendations led to actual treatment decisions and how the use of Decipher has impacted patients' health-related quality of life."

The study included a total of 265 patients who enrolled at 19 community and academic practice settings. At baseline, prior to receipt of Decipher test results, physicians recommended primarily a 'wait-and-see' approach for most patients, irrespective of established clinical risk factors. With knowledge of Decipher test results, 96% and 74% of men with low genomic risk in the adjuvant and salvage arms, respectively, as indicated by Decipher test results, were recommended to observation. Among men whose Decipher test results showed a high genomic risk of metastasis, 37% and 69% of men in the ART and SRT arms, respectively, were recommended to receive intensification to multi-modal therapy. The study also indicated that decision quality was improved for patients considering post-surgery radiation therapy when exposed to Decipher test results, and that the fear of prostate cancer recurrence in the adjuvant and salvage arms decreased among low-risk patients.

"The clinical utility of Decipher seen in this interim analysis demonstrates that knowledge of Decipher test results can influence treatment recommendations and improve decision quality among men with prostate cancer," said Doug Dolginow, M.D., chief executive officer of GenomeDx. "As men in our society are living longer than ever before, determining the appropriate treatment of prostate cancer, which may save or extend life, is important. We believe incorporating Decipher into clinical practice will allow for better stratification of risk, improve decision-making and allow patients to be more confident with the difficult choices they may have to make."

About Decipher GRID® and Decipher® Prostate and Bladder 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 radical cystectomy. 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.

More information is available at www.deciphertest.com and www.deciphergrid.com

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 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 operates a clinical laboratory in San Diego, California.

Learn more at www.GenomeDx.com

SOURCE GenomeDx Biosciences

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