Veracyte's New Study Shows The Decipher Prostate Test Is Prognostic For Prostate Cancer Progression Among Patients Undergoing Active Surveillance

Veracyte, Inc. (NASDAQ:VCYT), a leading cancer diagnostics company, today announced that a new study published in JCO Precision Oncology shows that, among patients undergoing Active Surveillance (AS) for prostate cancer, the Decipher Prostate Genomic Classifier is prognostic for identifying those whose disease is likely to progress. The findings make the Decipher test the only gene expression test to have treatment-outcome data from a prospective, multi-center, phase 2, randomized trial in the AS population.

Patients whose prostate cancer is found at an early stage and who are clinically low or intermediate risk are commonly offered AS, meaning they are closely monitored rather than undergo intervention such as surgery or radiation. Identifying the optimal candidates for active surveillance, however, is not always easy, as clinical indicators are limited in their ability to identify those who may be at a higher risk of future grade reclassification or cancer progression.

"The findings from the ENACT trial analysis demonstrate that the Decipher Prostate test is a predictor of disease progression on AS," said Elai Davicioni, Ph.D., Veracyte's medical director for Urology. "These data also further reinforce Veracyte's commitment to evidence generation that supports the Decipher Prostate test's ‘Level 1B' evidence status – the highest among commercially available gene expression tests – in the most recent NCCN® Guidelines* for prostate cancer."

The new findings are from the biomarker analysis study of the ENACT clinical trial (NCT02799745) that aimed to compare the efficacy and safety of enzalutamide monotherapy plus AS vs AS alone in patients with low-risk or intermediate-risk prostate cancer. The study included 121 AS patients from the randomized trial who were monitored and followed for 3 years. In the AS alone or control arm, among patients with available tumor samples (n=65), the Decipher Prostate test predicted increased rates of disease progression after adjusting for baseline clinical risk factors (MVA HR [95% CI] per 10% increase in score: 1.17 [1.01 to 1.35]; P = 0.04).

The findings also demonstrated the use of Decipher GRID (Genomic Resource for Intelligent Discovery) as a research tool to help advance scientific understanding of prostate cancer. Specifically, the researchers evaluated whole-transcriptome data derived from Decipher Prostate testing of each sample in the study to assess the Decipher Prostate test and other, research-based biomarkers that could potentially indicate which tumors would be more likely to respond to treatment with enzalutamide, an androgen receptor (AR) signaling inhibitor. They observed that the subset of patients with higher Decipher scores, as well as luminal and high AR activity subtypes, had greater responses to enzalutamide.

"Our Decipher GRID tool enables researchers to analyze whole-transcriptome data for prostate cancer samples to gain further insights about the disease, which can ultimately further improve patient care," said Dr. Davicioni. "This study is a strong example of the Veracyte Diagnostics Platform in action, whereby we use a comprehensive, whole-transcriptome approach to develop a test, which fuels our ability to demonstrate the test's performance and utility, and also enables new discovery efforts."