GenomeDx Biosciences, San Diego and Vancouver, British Columbia, Canada, recently announced first validation data supporting the use of its Decipher prostate cancer classifier for analyzing diagnostic needle core biopsies to help guide the treatment of men newly diagnosed with prostate cancer.

In studies involving more than 3,000 patients, Decipher has previously been validated for metastasis prediction after radical prostatectomy. In the most recent study, the test was used to perform genomic analysis of diagnostic biopsy specimens, and accurately predicted 10-year postoperative metastasis.

For the recent study, Decipher scores were evaluated from a cohort of primarily low- and intermediate-risk patients with available needle biopsy tissue who went on to receive radical prostatectomy at the Cleveland Clinic. Notably, Decipher reclassified 66.6% of intermediate-risk patients, as assessed by guidelines of the National Comprehensive Cancer Network (NCCN), into either lower (48.1%) or higher (18.5%) Decipher risk groups. The results of the study show the potential of Decipher to improve clinical decision-making even upon initial diagnosis of prostate cancer.

“Advancing research on the next generation of genomic tests for prostate cancer patients allows us to continue to refine our ability to more precisely assess a patient’s tumor aggressiveness to help inform clinical decision-making,” says Eric Klein, MD, chairman of the Glickman Urological and Kidney Institute at the Cleveland Clinic. “Decipher has proven itself a valuable tool for postprostatectomy patients. This study in a small cohort of patients hints at the potential utility of the test to accurately determine risk of tumor spread for patients at initial diagnosis.”

Evaluation of Decipher in 57 patients yielded a concordance index of 0.80 for prediction of metastasis at 10 years, compared to 0.75 for NCCN risk criteria alone. A combined model consisting of Decipher and NCCN risk criteria improved the accuracy to yield a concordance index of 0.88. Multivariable analysis found that Decipher was the only significant predictor of metastasis when adjusting for age, preoperative prostate-specific antigen score, and biopsy Gleason score (P = 0.02). These findings demonstrate that Decipher is significantly able to predict metastasis independent of clinical factors in men newly diagnosed with prostate cancer. The additional genomic information provided by Decipher may help identify men who may be optimal candidates for active surveillance or better identify appropriate first-line therapy for men with intermediate disease.

Doug Dolginow, MD, GenomeDx.

Doug Dolginow, MD, GenomeDx.

“We are pleased by the results of this study, and are looking forward to making the benefits of Decipher available to the almost 250,000 men in the US who are diagnosed with prostate cancer every year,” says Doug Dolginow, MD, CEO of GenomeDx. “We believe the additional information available to patients and physicians with the Decipher Genomic Resource Information Database (GRID) will further enable the future of genomic medicine for newly diagnosed men with prostate cancer.”

The Decipher GRID is the world’s largest genomic expression data-sharing program in urologic oncology, created to enable precision medicine improvements for patient care. GRID unifies whole-genome data with clinical outcomes from thousands of patients evaluated with Decipher, providing unprecedented data-sharing capabilities. Ultimately, GRID seeks to use patient tumor genomic information to better match an individual to a targeted therapy with the highest likelihood of providing a benefit.

For more information, visit GenomeDx Biosciences.