Agendia®, Inc., a leader in precision oncology for breast cancer, today announced that more than 25,000 patients have now been enrolled in its flagship FLEX Study (NCT03053193), marking a major milestone in Agendia’s mission to advance more individualized breast cancer care.

The MammaPrint, BluePrint, and Full-genome Data Linked With Clinical Data to Evaluate New Gene EXpression Profiles (FLEX) study in early-stage breast cancer is a large-scale, prospective, observational breast cancer study that links whole transcriptome profiling, including MammaPrint® and BluePrint®, with complete clinical data. The primary goal of this project is to capture genomic and clinical data for at least 30,000 breast cancer patients and to follow them for up to 10 years. Designed to include patient groups historically underrepresented in clinical research, the FLEX Study enables researchers to investigate questions that extend beyond the scope of traditional randomized clinical trials.

As of July 2025, 12,354 patients enrolled in FLEX (54%) have reached three years of follow-up, and 6,206 patients (27%) have reached five years of follow-up. FLEX has 2,235 self-reported Black/African American, 2,125 Latin American/Hispanic, and 602 Asian American/Pacific Islander early-stage breast cancer (EBC) patients – making FLEX a highly diverse study. Similarly, FLEX represents one of the largest cohorts of invasive lobular carcinoma (ILC), with 2,981 ILC and 853 mixed ILC/ductal histology tumors. Studies from FLEX have led to eight peer-reviewed publications, and over 66 abstracts at congresses internationally, including 11 presentations focused on therapy selection, 12 on differences in tumor biology and clinical outcomes by race/ethnicity and two on ILC.

As the study continues to mature, findings from FLEX are contributing to the growing body of evidence supporting the use of genomic and molecular information in treatment planning – enabling personalized cancer treatment based on the biology of each patient’s tumor, while actively reducing health disparities.

“Reaching more than 25,000 patients is a meaningful milestone for FLEX and, most importantly, represents thousands of individual breast cancer journeys that are helping expand our understanding of the disease,” said Mark Straley, Chief Executive Officer. “By bringing together patients across a broad range of ages, ethnicities, genders and health statuses and connecting their tumor biology with treatment decisions and long-term outcomes, FLEX is helping generate the real-world evidence needed to make personalized breast cancer care a reality.”

Select examples of the clinical impact from the FLEX Study include:

  • Personalizing chemotherapy decisions: FLEX real-world data show that MammaPrint risk predicts chemotherapy benefit in HR-positive/HER2-negative EBC1. Patients with MammaPrint High Risk 1 and High Risk 2 tumors saw greater benefit from chemotherapy (5.5% and 10.9%, respectively), while Low and UltraLow Risk groups derived minimal benefit, supporting more individualized decisions about chemotherapy.

  • Guiding selection of chemotherapy regimen: FLEX data informed updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for breast cancer, demonstrating that patients with High Risk 2 tumors derive a survival benefit from adding anthracyclines to taxane-based chemotherapy regimens2.

  • Identifying aggressive tumor subtypes driving racial survival disparities: FLEX analyses across racial groups found that molecular subtyping by BluePrint further classified 55% of ER-positive/HER2-negative breast cancers as Basal-type tumors that were more common in Black women3. Identifying these overlooked cases highlights a potential undertreatment gap, while demonstrating how understanding tumor biology improves survival outcomes.

“FLEX provides a unique view into how breast cancer is being treated today, capturing contemporary treatment patterns alongside tumor biology and clinical outcomes,” said William Audeh, M.D., M.S., Chief Medical Officer at Agendia. “As therapies such as CDK4/6 inhibitors and immunotherapy become increasingly part of the treatment landscape, FLEX can help us understand their use and outcomes across diverse patient populations. As we mark Breast Cancer Awareness Month this October, we would like to express our gratitude to the investigators, patients and partners who have made FLEX one of the largest breast cancer research platforms in the world and whose contributions continue to expand what we can learn from real-world clinical care.”

References

1. MammaPrint predicts chemotherapy benefit in HR+HER2- early breast cancer: FLEX Registry real-world data. JNCI Cancer Spectr. 2025 Sep 1;9(5):pkaf079. doi: 10.1093/jncics/pkaf079.

2. Prediction of Anthracycline Benefit in Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Early-Stage Breast Cancer by the MammaPrint 70-Gene Signature for Patients Enrolled in the FLEX Study. JCO Precis Oncol 10, e2501285(2026) Volume 10, Number 6 DOI: 10.1200/PO-25-01285

3. Identification of racial disparities across MammaPrint and BluePrint subtypes in HR + HER2- breast cancer. npj Breast Cancer 12, 68 (2026). https://doi.org/10.1038/s41523-026-00932-1

About Agendia

Agendia is a global leader in precision oncology focused on early-stage breast cancer. The company’s genomic assays, MammaPrint + BluePrint, deliver essential biological insights to inform personalized treatment decisions for patients and their care teams. With operations in Amsterdam and Irvine, Agendia partners with academic and community oncology centers worldwide to generate real-world evidence through the landmark FLEX Study (NCT03053193), the largest whole-transcriptome registry of early-stage breast cancer.

About MammaPrint

MammaPrint is the only FDA-cleared gene expression profiling test that assesses a woman’s risk of distant metastasis in early-stage breast cancer. By analyzing 70 key genes in a tumor, it stratifies risk into four categories — UltraLow Risk, Low Risk, High Risk 1, and High Risk 2 — to help guide treatment planning, including chemotherapy benefits and de-escalation decisions.

About BluePrint

BluePrint is an 80-gene molecular subtyping assay that reveals the functional biology driving tumor growth, classifying tumors as Luminal-type, HER2-type, or Basal-type. By defining intrinsic subtypes beyond traditional immunohistochemistry, BluePrint provides critical insights to optimize treatment selection and improve outcomes.

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