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 testing 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 testing 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 is a randomized, blinded, Phase 3 trial that is evaluating if outcomes are similar when women, identified as having low risk by a genomic test (the Prosigna test) are treated with hormonal therapy alone vs the combination of hormonal therapy with chemotherapy. If successful, the OPTIMA study will help identify patients who do not benefit from chemotherapy and can avoid treatment and side effects. Prosigna was exclusively selected for OPTIMA based on a thorough analysis of available molecular tests.

The OPTIMA study will assess whether the Prosigna test improves chemotherapy use for patients with hormone-sensitive, early-stage breast cancer, including cases where cancer has spread to the lymph nodes.

Group 1: Standard chemotherapy +5-10 years hormone therapy

Group 2: Prosigna test guides treatment decision

• High-risk result: chemotherapy + hormone therapy
• Low-risk result: hormone therapy alone

Patients will be followed for 5-10 years

Data from OPTIMA Prelim feasibility study presented at ESMO Breast 2025

• Prosigna showed higher accuracy in high-risk patients vs. initial test
• 19% of patients had conflicting test results
• 25% recurrence rate in discordant cases suggests some patients may have been incorrectly guided to avoid chemotherapy

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

>4,700 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