Findings From Two Large-Scale, Real-World Data Sets Reinforce Clinical Utility of Veracyte’s Decipher Prostate Genomic Classifier

Data from studies encompassing over 100,000 prostate cancer patients presented at American Urology Association (AUA) 2023 Annual Meeting

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Veracyte, Inc. (Nasdaq: VCYT) announced that new data presented at the American Urological Association (AUA) 2023 Annual Meeting validate the real-world performance and clinical utility of the company’s Decipher Prostate Genomic Classifier. The findings are from two separate, large-scale studies evaluating the Decipher Prostate test among a total of more than 100,000 individuals with prostate cancer and reinforce its role as a new standard of care to help inform treatment decisions for these patients.

“The prognostic performance and utility of the Decipher Prostate test have been established previously in the context of more than 70 peer-reviewed publications,” said Elai Davicioni, Ph.D., Veracyte’s medical director for Urology. “These new, large-scale studies demonstrate that the Decipher Prostate test’s performance and utility are being confirmed in the real world and should give physicians even further confidence in the test’s results and clinical value.”

The 22-gene Decipher Prostate Genomic Classifier provides a score ranging from 0 to 1, categorized as low (0.60) of metastasis. It is the most validated prognostic biomarker for risk stratification among patients with prostate cancer to help determine who may benefit from treatment intensification.

In the first study presented at AUA2023 (#MP44-17), researchers used data from the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) database, the most commonly used cancer database in the United States, to examine treatment with conservative management (i.e., active surveillance) among patients with favorable-risk disease who were tested with the Decipher Prostate classifier. Specifically, the researchers examined the relationship between the Decipher test results, receipt of treatment and adverse pathology (AP) at the time of radical prostatectomy (RP) - a surrogate for poor outcomes in this otherwise low-risk population.

Researchers linked data from 2,744 patients in the SEER registry who were tested with the Decipher Prostate test between 2016 and 2020. They then quantified the association of these patients’ Decipher Prostate test scores with receipt of surgery, upgrading, upstaging and adverse pathology at RP, and compared these associations to those of tumor volume, PSA, patient age and Gleason score at diagnosis.

Results show that Decipher Prostate testing – regardless of individual patients’ test scores – was independently associated with a two-fold increase in conservative management utilization among those with favorable-risk disease (OR 2.1, 95% CI 1.9-2.5, p