Decipher Biosciences Announces Publication of a Prospective Clinical Study Demonstrating that the Use of Decipher Prostate RP Guides Post-Operative Management Decisions and Improves Patient Outcomes

Decipher Biosciences Announces Publication of a Prospective Clinical Study Demonstrating that the Use of Decipher Prostate RP Guides Post-Operative Management Decisions and Improves Patient Outcomes

San Diego – December 16, 2019

Decipher Biosciences, a commercial stage precision oncology company initially focused on urologic cancers, today announced that recent findings from a prospective study demonstrate the clinical utility of the Decipher Prostate Genomic Classifier after radical prostatectomy. The study shows that when treatment decisions were made and followed based on Decipher Prostate RP genomic test results, patient outcomes were significantly improved. Findings from this study appear in Nature’s journalProstate Cancer and Prostatic Diseases, and add to the existing evidence supporting the clinical utility and benefit of Decipher Prostate RP in the management of men with localized prostate cancer.  This study was conducted, in part, by researchers at Thomas Jefferson University.

Following a review of Decipher clinical validation data, a multidisciplinary tumor board at Thomas Jefferson University independently developed a guideline based on patient genomic risk, employing Decipher as the determining factor for treatment recommendations in eligible prostate cancer patients. Per the tumor board’s guideline, patients with adverse pathological findings after radical prostatectomy would receive the Decipher Prostate RP genomic test. Patients with Decipher high-risk scores were recommended for immediate treatment, and those with Decipher low- and intermediate-risk scores were recommended for observation.

In the prospective clinical study, 135 patients were given treatment recommendations according to the tumor board’s guideline and were monitored for disease progression for two years. The study authors reported a 3% rate of disease progression in Decipher low- and intermediate-risk patients who followed the tumor board’s guideline recommendation of observation, with no significant benefit for those who did not and instead opted for immediate treatment.  Decipher high-risk patients who did not follow the tumor board’s guideline recommendation of immediate treatment experienced a 25% rate of disease progression, whereas only 3% of those who followed the recommendation progressed.

“Our findings show that use of Decipher Prostate RP allows us to appropriately treat the men with adverse pathology after surgery who are most likely to derive maximum benefit,” said Robert Den, M.D., radiation oncologist and associate professor at Thomas Jefferson University and an author of the study. “We can also identify the men who may be safely observed and avoid the incontinence and sexual dysfunction commonly associated with immediate radiation following radical prostatectomy.”

A second aspect of this study examined the impact of Decipher genomic testing on treatment decisions in a diverse practice setting of 823 providers and 3,455 patients in the adjuvant setting nationwide. The authors reported that use of Decipher genomic testing results in a higher rate of observation for patients with Decipher low- and intermediate-risk scores, and increased utilization of immediate treatment for patients with Decipher high-risk scores.

“These findings demonstrate that Decipher provides critical information for the management of patients with prostate cancer, and establishment of treatment guidelines based on Decipher testing results improves patient outcomes,” said Tina Nova, Ph.D., Decipher Biosciences’ president and chief executive officer. “Taking into account the practice patterns observed with widespread use of the test, we believe that Decipher is already making a meaningful impact on the lives of prostate cancer patients in the United States.”

About Decipher Prostate RP and Decipher GRID

Our Decipher Prostate RP genomic tests are currently marketed and sold to physicians treating prostate cancer for patients who have received a radical prostatectomy and are being considered for additional therapy. The test reports the Decipher score which prognosticates a patient’s risk of metastasis within five years. The Decipher score is intended to improve clinical decision making by helping physicians identify patients who have high risk of metastasis and require more intensive therapy or who have low risk of metastasis and can reduce treatment intensity. We have obtained Medicare coverage for patients, including for those who have been diagnosed with adverse pathology following a radical prostatectomy and are being considered for additional therapy. Decipher Prostate RP can help guide physicians to better select the appropriate therapy for a specific patient, which in turn can result in improved patient outcomes.

Decipher GRID is our Real-World Evidence genomic database containing over 75,000 urologic cancer transcriptomes matched to patient demographics and including clinical trial outcome data, which is one of the largest and well-annotated urologic cancer genomic databases in the world. Decipher GRID’s patient data is derived from decades of clinical trials and is continuously being expanded through a growing community of pharmaceutical and academic partners. The diversity of clinical sample inputs, ranging from global clinical trials to standard-of-care practices in urban, suburban and rural centers, help provide a comprehensive view of the future and current states of the practice of urologic cancer care. We leverage Decipher GRID outputs to partner with investigators and pharmaceutical companies to help identify patient populations that might benefit from earlier use of proprietary drugs or combination therapeutic strategies, or that are prime candidates for novel therapeutics. Decipher GRID is our proprietary engine that drives product development for us, and informs the product development efforts for our pharmaceutical partners.

About Decipher Biosciences

Decipher Biosciences is a commercial-stage precision oncology company committed to improving patient care, initially focused on urologic cancers. Our novel prostate cancer genomic testing products, Decipher Prostate Biopsy and Decipher Prostate RP, provide valuable information about the underlying biology of a patient's tumor, assisting physicians in their selection of an optimal therapy. Our differentiated approach measures the biological activity of a patient's entire tumor genome, known as whole transcriptome analysis, and applies proprietary machine learning algorithms to help physicians improve therapy selection and accelerate adoption of new therapies into the standard of care. Decipher Biosciences is headquartered in San Diego, California.

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