Agendia to Present New FLEX Study Data at ASBrS 2026 Confirming the Consistent Performance of MammaPrint + BluePrint Across Diverse Racial Groups in Genomically Basal-Type Breast Cancer

Multivariate analyses reveal that pathologic complete response is associated with transcriptomic differences and chemotherapy type, rather than self-reported race

IRVINE, Calif. & AMSTERDAM--(BUSINESS WIRE)--Agendia^®, Inc., a leader in precision oncology for breast cancer, today announced that it will present new data from the FLEX Study at the 27th Annual Meeting of the American Society of Breast Surgeons (ASBrS 2026^®), demonstrating that MammaPrint^® + BluePrint^® perform consistently across self-reported race in patients with genomically High-Risk, Basal-Type early-stage breast cancer who are receiving neoadjuvant chemotherapy. In multivariate analyses, pathological complete response (pCR) was driven by biological and treatment-related factors rather than race itself, supporting the robustness of genomic profiling across diverse patient populations.

Poster #1062 | Friday, May 1, 6:00 p.m. – 7:00 p.m. PST | Presenter: Nathalie Johnson
Genomically Basal-Type tumors demonstrate distinct immune profiles and chemosensitivity across self-reported race among patients enrolled in FLEX receiving neoadjuvant chemotherapy

In this real-world cohort of 451 patients with BluePrint Basal-Type early-stage breast cancer treated with neoadjuvant chemotherapy, 46 percent achieved a pCR. While pCR rates varied across self-reported race, multivariate analyses demonstrated that pCR was significantly associated with MammaPrint index, patient age and receipt of platinum-based chemotherapy, rather than race itself.

Whole transcriptome analysis revealed immune active transcriptional profiles among tumors achieving pCR across all racial groups. Importantly, among patients who achieved pCR, significant differences in pathway activation and immune cell composition were observed across race, highlighting biological heterogeneity within chemotherapy-sensitive Basal-Type disease. These findings demonstrate how BluePrint Basal-Type classification captures shared biology associated with response to therapy, while whole transcriptome analysis enables deeper characterization of race-associated molecular and immune differences among responders.

“The FLEX Study provides a unique opportunity to evaluate tumor biology in a population that is more broadly representative than what is typically seen in clinical trials,” said Nathalie Johnson, Medical Director of the Legacy Cancer Institute and the Legacy Breast Health centers in Portland, Oregon, and first author of the study. “By including patients from diverse racial backgrounds, FLEX allows us to understand that patient outcomes are tied to shared and distinct biological features. More robust genomic and transcriptomic analyses are crucial in patient selection and in determining therapies that will result in higher pCR in all patient populations. This will help move us closer to equity in treatment outcomes.”

“These results align with findings from our recent publication in npj Breast Cancer, which highlight the strength of MammaPrint + BluePrint as biology-driven tools that perform consistently across self-reported racial groups and underscore the importance of identifying patients with High Risk Basal-Type tumors, which are twice as common among Black women compared to White women,” said William Audeh, MD, MS, Chief Medical Officer at Agendia. “By identifying tumors most likely to respond to therapy based on intrinsic biology, our assays support treatment decisions that are informed by molecular features rather than by demographic characteristics.”

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.