ESMO Breast Press Release

Real-world analysis shows BluePrintยฎ identifies chemotherapy-sensitive Basal-type tumorsย  among MammaPrintยฎ High Risk HR+ HER2- breast cancers, supporting more personalizedย  treatment strategies.ย 

IRVINE, CALIF., U.S., and AMSTERDAM, NETHERLANDS โ€“ May 6, 2025 โ€“ Agendiaยฎ, Inc., today announced that new data from its ongoing FLEX Study will be presented at the upcoming ESMO Breast ย Cancer 2025 congress taking place May 14-17 in both Munich, Germany and virtually.ย 

The FLEX Study (NCT03053193) is a prospective real-world evidence, observational breast cancer study designed to correlate whole transcriptome gene expression in early-stage breast cancer with clinical outcomes, and to evaluate how genomic insights can inform treatment decisions in early-stage breastย  cancer. In this analysis, researchers examined the impact of BluePrint, Agendiaโ€™s 80-gene molecular subtyping assay, on pathological complete response (pCR) rates and chemotherapy (CT) decision-making in patients with hormone receptor-positive (HR+), HER2-negative tumors classified as High Risk byย  MammaPrint. BluePrint further stratified these tumors into Basal or Luminal B subtypes, offering a more nuanced view of tumor biology and potential treatment response.ย 

The poster presentation, titled โ€œThe Impact of the 80-gene signature on pCR and chemotherapy treatment decisions in Early-Stage Breast Cancer: A FLEX Analysis [70P],โ€ (A.M. Brufsky, et al.), highlights findings from the analysis of two cohorts from the FLEX Study: one consisting of patients who underwent genomic analysis on pre-operative core needle biopsy, and received neoadjuvant chemotherapy with available pCR data and another cohort with documented physician chemotherapy recommendations. The analysis found that patients with MammaPrint High Risk, HR+ HER2- Basal-type tumors were more likely to achieve a pCR following neoadjuvant chemotherapy compared to those withย  Luminal B tumors. The analysis also showed that these Basal-type tumors were more frequently recommended for chemotherapy overall, more often treated with neoadjuvant chemotherapy specifically, and received more intensive regimens compared to Luminal B tumors. These results suggestย  that BluePrint provides actionable molecular insights that physicians are using to inform real-worldย  treatment decisions, even among patients already eligible for chemotherapy based on MammaPrintย  High Risk status.ย 

โ€œThese results reinforce the value of BluePrint in helping physicians personalize treatment plans for early-stage breast cancer,โ€ said Adam Brufsky, MD, PhD, Professor and Associate Chief of Hematology and Oncology at UPMC Hillman Cancer Center. โ€œBy identifying Basal-type tumors that are more likely toย  respond to chemotherapy, BluePrint can guide decisions about treatment intensity and timing that alignย  with each patientโ€™s individual tumor biology.โ€ย 

Poster Presentation Details:ย ย 

  • Title: The Impact of the 80-gene signature on pCR and chemotherapy treatment decisions inย  Early-Stage Breast Cancer: A FLEX Analysis [70P]ย ย 
  • Date and Time: Thursday, May 15, 12:00 PM CESTย 
  • Location: ICM โ€“ International Congress Center of the Munich Messe, Hall B0

About Agendiaย 

Agendia is a leading provider of innovative solutions in the field of precision oncology. With a focus on early-stage breast cancer, Agendia offers reliable biological insights that inform personalized treatmentย  decisions for patients and their care teams. Their advanced genomic assays, MammaPrintยฎ + BluePrintยฎ,ย  enable clinicians to quickly identify the most effective treatment plan, minimizing the risk of both under and over-treatment.ย 

Agendia was founded in 2003 and is headquartered in Amsterdam with its state-of-the-art laboratory facility located in Irvine, CA. Led by world-renowned scientists and oncologists, Agendia is committed to advancing genomic insights through ongoing research. This includes the notable FLEX Study โ€“ the worldโ€™s largest whole transcriptome Real-World Evidence-based Breast Cancer database which aims to revolutionize precision in breast cancer management. With cutting-edge technology, research and innovation, Agendia strives to shape the future of precision oncology and make a significant impact in the fight against breast cancer.ย 

About BluePrintย 

BluePrintยฎ is a gene expression profiling test that reveals the driving forces behind a tumorโ€™s growth atย  the earliest stage possible in a womanโ€™s breast cancer care journey to help optimize and personalizeย  treatment planning. As the only molecular subtyping test available in the U.S., BluePrintยฎ goes where pathology cannot, offers critical insights that providers may otherwise have not known to act on, and gives women the best chance to return to a life not defined by cancer. BluePrintยฎ measures the activity of 80 key genes that are involved in a tumorโ€™s growth to classify a tumor as Luminal-type, HER2-type, orย  Basal-type, each of which warrant distinct treatment pathways. By revealing the distinct underlying biology of a womanโ€™s tumor, BluePrintยฎ can catch often misclassified, yet highly aggressive, Basal tumors, so women can be prescribed the most appropriate treatment from the start.ย 

Media Contactย 

marketing@agendia.com