Phase III Trial Shows Veracyte’s Decipher Prostate Test Can Predict Benefit from Adding Abiraterone to Treatment in Very High-Risk Prostate Cancer

SOUTH SAN FRANCISCO, Calif., Oct. 23, 2026 -- Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, today announced new data showing that its Decipher® Prostate Genomic Classifier can predict benefit from adding abiraterone to androgen deprivation therapy (ADT) in men with clinically very high-risk nonmetastatic prostate cancer. The findings will be presented tomorrow in a proffered paper oral presentation at the European Society for Medical Oncology (ESMO) Congress 2026 by Dr. Sarah Howlett of University College London (UCL).

The retrospective analysis of the randomized Phase III STAMPEDE trial provides new Level 1B predictive evidence for Decipher in men with clinically very high-risk nonmetastatic prostate cancer. This predictive evidence bolsters Decipher’s high-risk claims to help physicians identify which patients are most likely to benefit from adding abiraterone to ADT. These findings build on Decipher’s long-established standing in guidelines for assessing the risk of cancer progression, as well as prior STAMPEDE analysis that was recently incorporated into the NCCN 2027 prostate cancer guidelines for high- and very high-risk disease.

For patients with very high-risk disease, the decision to add abiraterone treatment carries significant consequences. Abiraterone can improve cancer outcomes when added to ADT but also adds side effects and treatment burden. Understanding a patient’s expected benefit from the additional treatment can help physicians and patients weigh the potential benefit alongside the impact on daily life.

“For men with very high-risk disease, preventing the cancer from spreading is critical, and understanding who benefits most from additional treatment can make a meaningful difference,” said Dr. Sarah Howlett, clinical research fellow in the Research Department of Oncology at UCL and the study’s presenter. “This analysis shows that the Decipher test can identify which patients in this study population were at greatest risk of prostate cancer-specific mortality and, therefore, may gain the greatest benefit from adding abiraterone to ADT. That gives physicians and patients evidence to make more confident treatment decisions based on the biology of the individual tumor.”

Key study findings in very high-risk patients:

• Decipher predicted benefit from adding abiraterone. The treatment-by-Decipher interaction for distant metastasis was statistically significant among node-negative patients (p=0.01), indicating that treatment benefit differed according to the Decipher score.
• Patients with higher Decipher scores saw greater benefit. At five years, the absolute benefit for adding abiraterone in terms of reducing distant metastasis events was 10% for patients with high scores and 11% for those with very high scores, compared to 2% benefit for those with lower scores.
• Decipher scores identified differences in the risk of cancer spread. Higher scores were associated with greater distant-metastasis risk and worse metastasis-free and overall survival in the STAMPEDE cohort. A separate analysis including data from over 27,000 real-world patients reinforced Decipher’s prognostic value across NCCN high- and very high-risk clinical groups.

The STAMPEDE analysis included 401 patients who received ADT alone or ADT plus abiraterone. The separate real-world analysis evaluated associations between Decipher scores and patient outcomes; it was not designed to assess prediction of abiraterone benefit.

“These findings expand Decipher’s predictive evidence to another consequential treatment decision: whether adding abiraterone will provide meaningful benefit for a man with very high-risk prostate cancer,” said Elai Davicioni, Ph.D., Veracyte’s medical director, Urology. “Building on the predictive data recently presented in intermediate-risk disease at ASTRO, these results strengthen Decipher’s role in helping physicians connect tumor biology to treatment selection across the prostate cancer risk continuum. We believe this growing evidence gives physicians a stronger reason to use Decipher before making decisions that can affect both cancer outcomes and patients’ quality of life.”

Decipher is already used in the care of patients with high-risk prostate cancer. The new findings strengthen the clinical rationale for testing before treatment-intensification decisions and support the potential for broader adoption and use in this population. Another trial prospectively evaluating the use of the Decipher test to guide treatment intensification or de-intensification in high-risk prostate cancer is the phase III biomarker-driven NRG-GU009 (PREDICT-RT) study, which completed enrollment earlier this year. This trial will add prospective evidence to the findings from the STAMPEDE trial, further expanding the predictive evidence around the Decipher test for treatment intensification with apalutamide, a different androgen receptor pathway inhibitor.

ESMO 2026 presentation

• Title: Transcriptome classifier risk stratification and intensification with androgen receptor pathways inhibitors (ARPI) for clinically high-risk prostate cancer
• Presenter: Dr. Sarah Howlett, University College London
• Date and time: October 24, 2026 at 10:15–11:45 a.m. CEST
  

About Veracyte

Veracyte (Nasdaq: VCYT) is a global diagnostics company with a vision to transform cancer care for patients around the world. The company’s molecular tests assess the unique biology of each patient’s tumor to help clinicians answer essential questions about cancer care. Veracyte’s Diagnostics Platform combines broad genomic and clinical data, advanced bioinformatics and AI, and a powerful evidence-generation engine to support continued innovation and pipeline development. The company’s portfolio includes the Afirma® Genomic Sequencing Classifier test, Decipher® Bladder Genomic Classifier test, Decipher® Prostate Genomic Classifier test, Prosigna® Breast Risk of Recurrence test, and the TrueMRD™ Monitoring Test for MIBC. For more information, visit Veracyte’s website or follow the company on LinkedIn or X (Twitter).

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements, including, but not limited to, statements regarding the potential clinical utility, impact and benefits of the Decipher Prostate Genomic Classifier; the ability of the Decipher Prostate test to predict which patients with very high-risk, nonmetastatic prostate cancer may benefit from the addition of abiraterone to ADT; the potential use of Decipher to inform treatment selection, including treatment-intensification decisions, and personalize treatment decisions; the potential for Decipher to help physicians connect tumor biology to treatment selection across the prostate cancer risk continuum; the potential for broader adoption and use in patients with very high-risk, nonmetastatic prostate cancer; the significance and clinical implications of the study findings; and the potential outcomes, validation and impact of the ongoing Phase III PREDICT-RT clinical trial. Forward-looking statements can be identified by words such as “appears,” “anticipate,” “intend,” “plan,” “expect,” “believe,” “should,” “may,” “will,” “enable,” “positioned,” “offers,” “designed,” “ultimately,” and similar references to future periods. Actual results may differ materially from those projected or suggested in any forward-looking statements. These statements involve risks and uncertainties, which could cause actual results to differ materially from our predictions. Additional factors that may impact these forward-looking statements can be found under the caption “Risk Factors” in our Annual Report on Form 10-K filed on February 26, 2026, as well as in other documents that we may file from time to time with the Securities and Exchange Commission. Copies of these documents, when available, may be found in the Investors section of our website at investor.veracyte.com. These forward-looking statements speak only as of the date hereof and, except as required by law, we specifically disclaim any obligation to update these forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise.

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