Newswire (Published: Monday, February 6, 2017, Received: Thursday, February 2, 2017, 12:02:47 PM CST)

Word Count: 827

By a News Reporter-Staff News Editor at Clinical Trials Week -- - GenomeDx Biosciences announced the first study that demonstrates the ability of the Decipher® Prostate Cancer Classifier Biopsy Test (Decipher Biopsy) to predict for the development of metastasis after radiation and androgen deprivation therapy (ADT). The study showed that Decipher Biopsy may accurately risk stratify men for metastatic failure after first-line radiation and ADT. The study, titled "Utilization of Biopsy-Based Genomic Classifier to Predict Distant Metastasis after Definitive Radiation and Short-Course ADT for Intermediate and High Risk Prostate Cancer," was published online this month ahead of print in HYPERLINK "" \nProstate Cancer and Prostatic Diseases (see also GenomeDx Biosciences).

Radiation and ADT is a standard first-line therapy for patients diagnosed with intermediate- and high-risk prostate cancer. While many men will be cured with this treatment, there remains a proportion of men whose cancer will progress after therapy and develop into metastatic disease. For these men, intensification of therapy beyond standard radiation and ADT may be required to further reduce the risk of metastasis. However, it is important to correctly identify patients who would benefit from treatment intensification, due to an inherent risk of additional toxicity and side effects associated with radiation and ADT treatment.

The study included a cohort of 100 men with intermediate- and high-risk prostate cancer who received definitive radiation plus a median of six months of ADT between 2001 and 2013 and had prostate biopsy samples available from the Dana-Farber/Brigham and Women's Cancer Center. The samples were analyzed for genomic risk through Decipher Biopsy, as well as clinically through standard risk models used to evaluate cancer recurrence - National Comprehensive Cancer Network (NCCN) and Cancer of the Prostate Risk Assessment (CAPRA) categorizations. After studying both clinical and genomic risk factors, researchers found that Decipher Biopsy outperformed clinical variables and accurately predicted the 5-year and 10-year risk of distant metastasis with c-indices of 0.76 and 0.78, respectively. In addition, while the study contained mostly men with intermediate-risk disease, in the 26% of men that were found to have a high Decipher-based genomic risk score (>0.60), 20% metastasized within 5 years of therapy despite their previous treatment. This suggests that these men may be candidates for treatment intensification or enrollment in clinical trials of novel therapy.

"This study highlights the significant value that Decipher Biopsy may provide for patients who choose radiation as the primary management of their prostate cancer," said study lead author Paul Nguyen, M.D., genitourinary disease center leader for radiation oncology at the Dana-Farber/Brigham and Women's Cancer Center and Harvard Medical School. "The ability to detect which men harbor aggressive disease will allow clinicians to more accurately identify the optimal treatment to enhance disease control and ultimately improve outcomes in this patient population."

Doug Dolginow, M.D., chief executive officer of GenomeDx, added, "The findings from this study are meaningful and suggest that Decipher may help physicians make better informed decisions about appropriate utilization of therapy at critical junctures in the care of prostate cancer patients. Decipher Biopsy provides clinicians with the ability to improve risk assessment and tailor treatment approaches to further reduce a patient's risk of metastasis."

About Decipher GRID® and Decipher® Prostate 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 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, 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 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 HYPERLINK "" \ and HYPERLINK "" \

Keywords for this news article include: Biopsy, Surgery, Genetics, Oncology, Androgens, Chemicals, Prostate Cancer, Drugs and Therapies, Prostatic Neoplasms, Risk and Prevention, GenomeDx Biosciences, Diagnostics and Screening, Operative Surgical Procedures.

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GenomeDx Biosciences Inc.
Harvard Medical School


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