Veracyte to Present Landmark OPTIMA and ENZAMET Trial Data at ASCO 2026, Strengthening Evidence for Genomic Testing in Breast and Prostate Cancer Care
Veracyte, a leading cancer diagnostics company, has announced that new data from two major Phase III clinical trials—OPTIMA and ENZAMET—will be presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, taking place May 29–June 2. The findings are expected to provide practice-influencing evidence supporting the use of Veracyte’s genomic tests, including Prosigna Breast Cancer Assay and Decipher Prostate Genomic Classifier, in guiding treatment decisions across breast and prostate cancers.
The company stated that the upcoming presentations represent a major milestone in precision oncology, demonstrating how genomic testing can help clinicians better match treatment intensity to individual patient risk while reducing unnecessary therapies and associated toxicities.
OPTIMA Trial Reinforces Role of Genomic Testing in Early Breast Cancer
One of the most anticipated presentations at ASCO 2026 will be the results of the OPTIMA trial, a large-scale Phase III randomized study led by University College London (UCL) and supported by the UK’s National Institute for Health Research (NIHR). The study enrolled more than 4,400 patients and was designed to address a critical question in early breast cancer management: which patients truly benefit from chemotherapy, and which patients can safely avoid it without compromising outcomes.
The OPTIMA trial specifically evaluated whether the Prosigna Breast Cancer Assay could be used to guide adjuvant chemotherapy decisions in patients with high clinical risk, estrogen receptor-positive (ER+), HER2-negative early breast cancer. By incorporating genomic risk profiling, the study aimed to reduce overtreatment in patients who may not derive meaningful benefit from chemotherapy, while ensuring that high-risk patients still receive necessary intensive therapy.
According to Veracyte, the trial results are expected to provide Level 1A evidence supporting Prosigna-guided treatment strategies, a designation that reflects the highest standard of clinical evidence in oncology practice.
Dr. Kelly Marcom, Medical Director for Breast Cancer at Veracyte, emphasized the significance of the findings, stating that the OPTIMA trial represents a major advancement in precision breast oncology.
“These results represent a major milestone and will provide Level 1A evidence supporting Prosigna-guided treatment decisions,” Marcom said. “These findings have the potential to transform how clinicians treat a large population of patients with breast cancer by enabling more personalized treatment decisions based on genomic insights.”
The study findings will be formally presented by Dr. Robert Stein of University College London Hospitals Biomedical Research Centre, who served as the OPTIMA trial chief investigator. His presentation is scheduled for Saturday, May 30, during the breast cancer session at ASCO 2026.
If the findings are adopted broadly, they could significantly reshape early breast cancer treatment pathways by reducing unnecessary chemotherapy exposure—an intervention associated with long-term side effects such as fatigue, neuropathy, cardiac toxicity, and cognitive impairment.
ENZAMET Study Expands Role of Decipher in Metastatic Prostate Cancer
In parallel with the breast cancer findings, Veracyte will also present new data from the ENZAMET trial, an international Phase III randomized study conducted by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP).
The ENZAMET study focuses on patients with metastatic hormone-sensitive prostate cancer and evaluates how the Decipher Prostate Genomic Classifier can help identify patients most likely to benefit from treatment intensification strategies, including the addition of docetaxel chemotherapy to standard androgen deprivation therapy (ADT) and enzalutamide-based regimens.
The independent analysis from ENZAMET examined whether genomic risk stratification could predict treatment benefit, particularly in identifying patients who may benefit from triplet therapy while sparing others from unnecessary chemotherapy exposure.
Dr. Christopher Sweeney of the South Australian Immunogenomics Cancer Institute at Adelaide University will present these findings during the Genitourinary Cancer session on Saturday, May 30. His presentation will focus on Decipher’s ability to stratify patients based on genomic risk and guide decisions regarding the addition of docetaxel in metastatic hormone-sensitive prostate cancer.
According to Veracyte, the ENZAMET data support the growing role of Decipher as a tool not only for prognosis but also for predicting therapeutic benefit in advanced prostate cancer settings.
“Together, these studies provide practice-changing evidence supporting the use of Veracyte’s tests in guiding treatment decisions across cancer types,” said Dr. Phillip Febbo, Chief Scientific and Medical Officer at Veracyte. “This allows clinicians to better match treatment intensity to individual patient risk, ensuring the right level of care while avoiding unnecessary treatment and its side effects.”
Broader Clinical Impact of Genomic Classifiers
The OPTIMA and ENZAMET trials are part of a growing body of clinical evidence supporting the use of genomic classifiers in oncology. These tests analyze tumor biology at the molecular level, offering insights that go beyond traditional clinical and pathological factors.
In breast cancer, tools like Prosigna help refine recurrence risk estimates, allowing clinicians to identify patients who may safely avoid chemotherapy. In prostate cancer, Decipher is increasingly used to assess tumor aggressiveness and predict disease progression, helping guide decisions about radiation, hormone therapy, and chemotherapy combinations.
Experts believe that integrating genomic data into clinical decision-making represents a major step toward truly personalized oncology care. By tailoring treatments based on tumor biology rather than relying solely on clinical staging, physicians can reduce both under-treatment and overtreatment.
Additional Research Presentations at ASCO 2026
Beyond the headline OPTIMA and ENZAMET trials, Veracyte will also present multiple additional studies at ASCO 2026, highlighting its expanding role in oncology diagnostics and artificial intelligence-driven cancer classification.
Prostate Cancer Risk Stratification and Treatment Intensification
One oral presentation will focus on a combined analysis of multiple clinical trials (NRG/RTOG 9202, 9413, 9902, and 0521), examining transcriptomic risk stratification to guide abiraterone treatment intensification in high-risk prostate cancer patients. The study aims to identify which patients benefit most from adding advanced hormonal therapies to standard treatment regimens.
Another presentation will explore how genomic classifiers contribute to NCCN risk reclassification in early prostate cancer. This research aims to improve risk stratification models and better define treatment pathways for patients with localized disease.
ENZAMET-Related Biomarker Evidence
Additional ENZAMET-derived analysis will further evaluate Decipher’s performance in predicting benefit from docetaxel when added to androgen deprivation therapy and enzalutamide. The findings strengthen evidence that genomic scores above certain thresholds may identify patients most likely to benefit from aggressive treatment intensification.
Poster Presentations Across Multiple Cancer Types
Veracyte will also present several poster abstracts across prostate, bladder, and breast cancer research areas.
One poster will examine real-world outcomes in octogenarian patients with high-risk localized prostate cancer, focusing on how genomic risk stratification influences treatment patterns and outcomes in older populations.
Another study evaluates neoadjuvant sacituzumab govitecan in muscle-invasive bladder cancer, including final results and biomarker analyses from the SURE-01 trial. This research explores how antibody-drug conjugates may improve outcomes in aggressive bladder cancer subtypes.
A separate poster will analyze the relationship between Artera multimodal artificial intelligence (MMAI) and the Decipher genomic classifier in localized prostate cancer. This study explores how AI-based pathology tools and genomic classifiers can complement each other in improving risk prediction accuracy.
Additional research will investigate molecular characteristics of residual disease following neoadjuvant treatment with sacituzumab govitecan, pembrolizumab, or combination therapy in muscle-invasive bladder cancer patients.
Toward a New Era of Precision Oncology
Taken together, the body of research being presented at ASCO 2026 underscores a broader transformation in cancer care. Genomic testing is increasingly being integrated into routine clinical practice, helping physicians move beyond traditional staging systems toward more personalized treatment frameworks.
Veracyte’s Prosigna and Decipher tests are positioned at the center of this shift, offering validated tools that help guide treatment intensity decisions in both early and advanced cancers.
As oncology continues to evolve, studies like OPTIMA and ENZAMET are expected to play a critical role in shaping future clinical guidelines, potentially reducing unnecessary chemotherapy use while ensuring that high-risk patients receive appropriately aggressive treatment.
The ASCO 2026 presentations mark an important step forward in validating precision oncology approaches and may influence treatment standards for years to come.
About Veracyte
Veracyte 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
