New data from the ongoing FLEX Study highlight the value of real-world evidence in personalizing chemotherapy decisions and improving outcomes in early-stage breast cancer

Agendia®, Inc., a leader in precision oncology for breast cancer, today announced it will present new results from the ongoing real-world FLEX Study (NCT03053193) at the 2025 San Antonio Breast Cancer Symposium (SABCS), taking place December 9-12 in San Antonio, Texas.

The company will present five posters, led by Agendia investigators and independent academic collaborators, that collectively highlight the broad clinical impact of MammaPrint^® + BluePrint^® genomic profiling in optimizing treatment decisions and improving outcomes for patients with hormone receptor positive, HER2-negative (HR+/HER2–) early breast cancer (EBC).

“We look forward to sharing these new findings from the FLEX Study, which spans more than 20,000 participants across 100 global sites, making it the largest and most diverse real-world evidence cohort for early-stage breast cancer,” said William Audeh, M.D., Chief Medical Officer at Agendia. “These results underscore our commitment to generating robust clinical evidence in settings beyond traditional clinical trials, ensuring the results can inform personalized treatment decisions across diverse patient populations and everyday clinical practice.”

The full list of abstracts & poster presentations is as follows:

3.2yr Updated Outcome Analysis of ACT-T Benefit by MammaPrint Risk Result

Improved 3-year IDFS with anthracycline-based therapy for patients with 70-gene signature High 2, Luminal B, HR+HER2– EBC

Poster #PS2-07-03 | Dec. 10, 5:00 PM - 6:30 PM | Presenter: Joyce O'Shaughnessy

MammaPrint Provides Stronger Prognostic Value Than Histologic Grade

70-gene signature high risk classification provides stronger prognostic value than histologic grade in HR+HER2– EBC

Poster # PS5-04-19 | Dec. 12, 12:30-2:00 PM | Presenter: Erin Cobain

Older Patients with Aggressive Breast Cancer May Benefit from Chemotherapy

HR+HER2– Patients Aged ≥70 with High Risk MammaPrint Benefit from Chemotherapy

Poster #PS3-08-17 | Dec. 11, 12.30 PM - 2 PM | Presenter: Reshma Mahtani

Understanding Breast Cancer in Overweight Latin American Patients

Distinct Immune and Metabolic Profiles in Latin American Breast Cancer Patients with Obesity

Poster #PS4-09-09 | Dec. 11, 5:00 PM - 6:30 PM | Presenter: Marcela Mazo Canola

30,000-Patient Study Expanding to Improve Breast Cancer Outcomes

FLEX: From Genomic Profiling to Real-World Insights in 30,000 Patients with Early-Stage Breast Cancer

Poster #PS5-09-19 | Dec. 12 12:30-2:00 PM | Presenter: Linsey P. Gold

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 a clinically validated genomic test that analyzes the expression of 70 genes in breast cancer tissue to determine the likelihood of distant metastasis. By providing risk stratification into four categories — UltraLow Risk, Low Risk, High Risk 1, and High Risk 2 — MammaPrint enables more personalized, data-driven guidance to chemotherapy and endocrine therapy planning.

About BluePrint

BluePrint is a 80-gene molecular subtyping assay that reveals the underlying biology driving tumor growth, classifying tumors as Luminal-type, HER2-type, or Basal-type. By defining intrinsic subtypes beyond conventional pathology, BluePrint offers deeper biological understanding to refine therapeutic decision-making and enhance clinical outcomes.

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