Agendia to Showcase New Evidence Supporting Expanded Use of MammaPrint® and BluePrint® at the 2026 ESMO Breast Cancer Congress
Agendia Inc., a leader in genomic testing for breast cancer, has announced the presentation of new clinical data at the European Society for Medical Oncology Annual Congress on Breast Cancer 2026, taking place from May 6–8 in Berlin, Germany. The company’s latest findings further reinforce the clinical value of its genomic assays, MammaPrint and BluePrint, in refining prognosis and informing treatment strategies in early-stage breast cancer (EBC).
At the congress, Agendia is presenting two scientific posters derived from analyses of major clinical datasets, including the ongoing FLEX Study and the landmark MINDACT trial. Together, these studies provide new insights into tumor biology, recurrence risk, and patient-specific factors that may influence outcomes in breast cancer.
FLEX Study Analysis Highlights Hidden Risk in Small Tumors
One of the featured presentations focuses on the prognostic performance of MammaPrint in patients with small, node-negative tumors, traditionally considered to have favorable outcomes. The retrospective analysis draws from the FLEX Study and includes data from 4,349 patients with T1a, T1b, and T1c early-stage breast cancer.
While these tumors are generally associated with a lower risk of recurrence based on size and clinical staging, the findings reveal significant biological heterogeneity within this group. Using MammaPrint, researchers were able to stratify patients into distinct genomic risk categories, uncovering a subset of patients with unexpectedly aggressive disease biology.
Specifically, the test identified a “High Risk 2” (H2) subgroup, representing approximately 10% of the overall study population and about 5% of patients with hormone receptor-positive (HR+) and HER2-negative disease. This subgroup demonstrated significantly worse recurrence-free survival (RFS) compared to patients classified as High Risk 1 (H1) or Low/UltraLow Risk (LR/UL).
Among all patients analyzed, the three-year RFS rate was 93% for those in the H2 category, compared to 98% for patients classified as low or ultra-low risk. In the HR+HER2- subgroup, the difference was similarly pronounced, with H2 patients experiencing a three-year RFS of 91%, versus 98% in the lower-risk categories.
These results suggest that tumor size alone may not be sufficient to guide treatment decisions in early-stage breast cancer. Even among patients with small, node-negative tumors, genomic profiling can reveal high-risk biology that may warrant more aggressive or tailored therapeutic approaches.
William Audeh, MD, Chief Medical Officer at Agendia, emphasized the clinical implications of these findings. He noted that while small tumors are often associated with a favorable prognosis, the FLEX Study data highlight the importance of identifying patients whose tumors harbor high-risk molecular features. According to Audeh, these patients may benefit from escalated treatment strategies or more personalized approaches that go beyond traditional clinical parameters.
MINDACT Analysis Explores BMI and Recurrence Risk
The second presentation builds on data from the MINDACT trial, a landmark study that established the clinical utility of genomic testing in guiding treatment decisions for breast cancer patients. This exploratory post hoc analysis examines the relationship between body mass index (BMI) and the dynamics of distant metastasis risk (DMR) in patients with estrogen receptor-positive (ER+) and HER2-negative breast cancer.
The analysis, co-authored by Agendia co-founder and MammaPrint inventor Laura van ‘t Veer, offers a nuanced view of how BMI may influence long-term outcomes. Contrary to conventional expectations, the findings indicate that higher BMI was not linearly associated with worse outcomes in this patient population.
In fact, patients classified as obese demonstrated a lower risk of distant metastasis compared to those with normal body weight, with a hazard ratio of 0.36. This unexpected result challenges widely held assumptions about the relationship between obesity and cancer prognosis, suggesting that the interaction may be more complex than previously understood.
The analysis also revealed dynamic patterns in recurrence risk over time. For patients with a BMI in the range of 24–28, the risk of distant metastasis appeared to peak around six years after diagnosis, followed by a rapid decline. This non-linear pattern underscores the importance of considering time-dependent factors when evaluating recurrence risk and planning long-term follow-up strategies.
Researchers concluded that the observed non-monotonic relationship between BMI and metastasis risk warrants further investigation in larger, prospective studies. Understanding these dynamics could help optimize patient management, including decisions around surveillance, lifestyle interventions, and adjuvant therapy.
Advancing Precision Oncology in Breast Cancer
Together, these two analyses highlight the growing role of precision oncology in breast cancer care. By integrating genomic data with clinical and patient-specific factors, tools like MammaPrint and BluePrint are helping clinicians move beyond one-size-fits-all treatment approaches.
The FLEX Study findings reinforce the importance of genomic testing in identifying high-risk patients who might otherwise be overlooked based on traditional staging criteria. Meanwhile, the MINDACT analysis introduces new considerations around patient characteristics such as BMI, suggesting that personalized care must account for a wide range of biological and lifestyle factors.
Agendia’s participation at ESMO Breast 2026 reflects its ongoing commitment to advancing the science of breast cancer diagnostics and improving patient outcomes through more precise and individualized treatment strategies.
As research continues to uncover the complexity of breast cancer biology, the integration of genomic profiling into routine clinical practice is expected to play an increasingly central role. The data presented by Agendia contribute to a growing body of evidence supporting the use of molecular diagnostics to refine risk assessment, guide therapy, and ultimately improve survival outcomes.
The insights generated from both the FLEX Study and the MINDACT trial analyses are likely to inform future research and clinical guidelines, particularly in the management of early-stage breast cancer. By identifying patients who may benefit from intensified treatment or alternative approaches, these findings have the potential to enhance decision-making and deliver more personalized care.
In summary, Agendia’s latest data presentations underscore the value of combining genomic testing with clinical insights to better understand disease behavior and optimize treatment strategies. As the field of precision oncology continues to evolve, such innovations are expected to reshape the standard of care for breast cancer patients worldwide.
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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