Clinical Studies Generate Evidence and Insights That Support Our Tests

This Phase 3 trial is evaluating whether early intervention with the immunotherapy tislelizumab—based on detection of cancer DNA fragments in the blood following treatment (i.e., minimal residual disease, or MRD)—improves outcomes for patients with lung, colorectal, pancreatic, and soft tissue sarcoma.

Our MRD platform was exclusively selected by leading cancer center Gustave Roussy to assess post-treatment strategies based on a patient’s MRD status. This trial could potentially help pave the way for a more personalized and effective approach to cancer care. Additionally, it can potentially support expansion of our MRD platform to multiple cancer types.

• MRD-positive patients: receive tislelizumab immunotherapy or placebo
• MRD-negative patients: receive reduced or standard follow-up care
• 24-month follow-up period for all participants

Gustave Roussy, France Leading global cancer research institution

Multiple centers in France

~700 patients will be enrolled

This phase 2, multicenter, prospective trial assesses outcomes following treatment with immunotherapy (atezolizumab) guided by circulating tumor DNA (ctDNA) status. The trial enrolled patients with muscle-invasive bladder cancer (MIBC) who received standard-of-care neoadjuvant therapy followed by cystectomy. ctDNA is assessed using tumor-informed digital droplet PCR (ddPCR), and the ddPCR results are then compared with Veracyte’s TrueMRD whole-genome approach as well as standard-of-care CT imaging.

The findings from this study could help transform care for patients with MIBC by providing better guidance on the need for adjuvant immunotherapy, with the potential to improve response rates and survival. We believe the results may also further demonstrate the performance and clinical utility of our novel MRD approach in patients with MIBC.

Data presented at the European Association of Urology Congress (EAU25) showed:
• Our approach demonstrated high accuracy and may improve overall clinical utility compared with ddPCR, a traditional blood-based MRD testing method
• Earlier detection compared with standard imaging

5 centers in Denmark

>190 patients enrolled

STAMPEDE is a long-running, large, randomized, prospective, Phase 3 trial that aims to assess new treatment approaches for patients with high-risk prostate cancer. A correlative retrospective analysis showed that Veracyte’s Decipher Prostate test predicted which patients with advanced prostate cancer are most likely to benefit from treatment intensification with chemotherapy (docetaxel) and which may avoid ineffective chemotherapy and its potential side effects.

The Decipher Prostate Genomic Classifier is already widely used to inform treatment decisions for patients with localized prostate cancer. STAMPEDE provides the first published evidence that the Decipher Prostate test can help personalize chemotherapy decisions for the growing population of patients whose prostate cancer has advanced beyond the prostate.

Data published in Cell (October 2025):

• Patients with higher Decipher scores: 36% improved survival with docetaxel
• Patients with lower Decipher scores: No benefit from treatment intensification with docetaxel
• Results were consistent regardless of disease volume
• 14-year median follow-up demonstrates long-term impact

• Large, randomized trial comparing treatment approaches
• 1,523 patients in retrospective Decipher Prostate sub-study analysis
• Standard hormone therapy vs. chemotherapy plus hormone therapy based on Decipher Prostate score
• Molecular testing performed on tumor samples retrospectively to predict treatment response

120 sites in UK & Switzerland

>12,000 patients enrolled

OPTIMA (Optimal Personalized Treatment of Early Breast cancer using Multi-parameter analysis) is an international, randomized, Phase 3 trial.

The OPTIMA study aims to determine if gene expression testing (specifically the Prosigna test) can safely allow patients with hormone-sensitive (ER-positive, HER2-negative) early breast cancer to avoid unnecessary chemotherapy.

OPTIMA provides the first evidence supporting test-directed chemotherapy decisions for:

• Node-positive premenopausal patients treated with ovarian function suppression
• Patients with up to 9 positive lymph nodes

Participants are randomized to receive standard treatment (chemotherapy and endocrine therapy) or test-directed treatment (using the Prosigna test to guide chemotherapy decisions).

Group 1: Standard treatment – chemotherapy followed by 5-10 years hormone therapy

Group 2: Prosigna test guided treatment decision

• High-risk result: chemotherapy followed by 5-10 years of hormone therapy
• Low-risk result: 5-10 years of hormone therapy alone

Patients will be followed for 5-10 years

>170 sites across UK, Norway, Sweden, Australia, New Zealand, Thailand

>4,500 patients enrolled to date

NIGHTINGALE is a prospective, multicenter, randomized trial that Veracyte is sponsoring to evaluate Percepta Nasal Swab test‘s ability to improve clinical decision-making for patients with lung nodules—helping to reduce unnecessary invasive procedures for patients with benign nodules while ensuring faster treatment for those with cancerous nodules.

Proving the Percepta Nasal Swab test’s clinical utility is essential for ensuring that clinicians will use it and that insurers will cover it. It is a key milestone before making our novel test widely available to clinicians and their patients.

• Patients with lung nodules are randomized to either have or not have Percepta Nasal Swab test results provided to their physician
• Patients are followed for up to 24 months or until a cancer diagnosis
• Management approaches and outcomes are compared between the two groups

Phillip Febbo, M.D. (Study Chairman) Veracyte

>90 sites in United States and Puerto Rico