GenomeDx Biosciences presents data on prognostic classifiers in diagnostic prostate needle biopsies

March 20, 2016 – SAN DIEGO. GenomeDx Biosciences announced results from a new study which demonstrates the ability to measure and evaluate biomarkers from RNA expression data obtained from prostate needle biopsies. The data demonstrate a high concordance in the genomic signatures between needle biopsy samples and post-prostatectomy tissue samples, providing preliminary evidence that the Decipher score may be predictive of disease progression following biopsy as well as following prostate surgery.

The results, published in the May 2016 issue of Journal of Molecular Diagnostics, and currently available online ahead of print, provide important findings about the feasibility of the Decipher Prostate Cancer Classifier test to obtain transcriptome-wide RNA expression data and to measure and evaluate prognostic classifiers in diagnostic prostate needle biopsies. The Decipher Prostate Cancer Classifier test used in the study, Decipher Biopsy, yielded genomic data from biopsy and surgical tissues of comparable quality. These data indicate that a sufficient amount of RNA can be consistently and successfully derived from the limited tumor tissue in biopsy cores, despite variation in the way biopsy cores are obtained from multiple institutes. The research was conducted by GenomeDx and its collaborators from Cedars Sinai Medical Center, University of California, San Francisco, and University Health Network, Toronto.

This study further supports findings of a study recently published in Urology (Klein et ‪al. Urology 2016) in validating and demonstrating the clinical utility of Decipher Biopsy in diagnostic needle biopsies.‬‬‬

“More than 800,000 men undergo prostate biopsy annually in the United States to identify prostate cancer, and this study increases confidence that reliable, quality genomic information can be obtained for those biopsies to better classify patient risk,” said Jeffry Simko, Ph.D., M.D., Professor of Clinical Pathology at the University of California, San Francisco. “Genomic biomarkers used by Decipher may help overcome current challenges of tumor heterogeneity and variability in staging of disease. This study demonstrates that the Decipher score may be predictive of disease progression in diagnostic prostate needle biopsies and warrants a larger, adequately powered study to validate this observation.”

The study compared analysis of a total of 158 samples from 33 men, including pre-operative needle core biopsies and tissues obtained from radical prostatectomy. Notably, researchers identified that 95 percent of transcriptomic features expressed in surgical samples were expressed in pre-surgery biopsy samples with a high expression correlation (r=0.96). The expression signature pattern yielded by Decipher Biopsy showed a high degree of correlation between the two sample types (r=0.70) providing strong evidence of the utility of Decipher Biopsy in prostate needle biopsies.

About Decipher® Prostate Cancer Classifier Tests

Our 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 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.

Source: GenomeDx Biosciences