Agendia to Unveil Novel Data on Genomic Risk and Treatment Disparities in Early-Stage Breast Cancer at 2025 ASCO® Annual Meeting

FLEX Study reaches milestone of 20,000 enrolled patients, providing new insights on genomic testing across diverse patient populations

Agendia^®, Inc., announced today that new data on its comprehensive genomic tests will be presented at the American Society of Clinical Oncology Annual Meeting (ASCO), taking place May 30^th – June 3^rd, 2025, in Chicago, Illinois.

The selected abstracts draw upon data from the ongoing FLEX Study (NCT03053193), which recently reached a significant milestone of 20,000 enrolled patients, nearly 10,000 of which have reached 3-year follow-up and 4,000 have reached 5-year follow-up. This real-world evidence study is providing critical insights into how genomic testing can address disparities in early-stage breast cancer care and optimize treatment selection across diverse patient populations. Since its launch in April 2017, the FLEX Study has enrolled patients across 100 sites in the U.S. and around the world, including 12 NCI-designated cancer centers, and has conducted over 40 sub-studies in several topics.

“The 2025 ASCO Annual Meeting provides an important platform to share our latest findings from the FLEX Study, which now includes crucial survival metrics for a modern cohort of early-stage breast cancer patients,” said William Audeh, MD, MS, Chief Medical Officer at Agendia. “The exceptional follow-up rates enable meaningful analysis of correlations between patient-reported genetic ancestry, molecular classifications, and treatment approaches, reinforcing the value of genomic testing in guiding equitable treatment decisions.”

The following are details of the abstracts that have been accepted as poster presentations:

• Association of MammaPrint and clinical outcomes by race among 5000 individuals with HR+HER2- early-stage breast cancer enrolled in FLEX
  
  Author: Cobain, E., et al.
  
  Presenter: Erin Cobain MD, Associate Professor in the Division of Hematology/Oncology at the University of Michigan Medical School, Ann Arbor and co-Principal Investigator of the SWOG S2206 Trial
  
  Session: Quality Care/Health Services Research
  
  Date / Time: Saturday, May 31, 2025 | 1:30 – 4:30 PM CDT
  
  
  
  
• Real-World Evidence from FLEX: Utility of MammaPrint in guiding treatment planning for patients aged 70 and older with early-stage breast cancer
  
  Author: Mahtani, R., et al.
  
  Presenter: Reshma Mahtani, DO, Baptist Health Miami Cancer Institute, Chief of Breast Medical Oncology at Baptist Health Wellness and Medical Complex
  
  Session: Quality Care/Health Services Research
  
  Date / Time: Saturday, May 31, 2025 | 1:30 – 4:30 PM CDT
  
  
  
  
• Association of ImPrintTN signature with survival outcomes by race in Basal-Type Triple Negative Breast Cancer (TNBC)
  
  Author: Sharma, P., et al.
  
  Presenter: Priyanka Sharma, MD, Professor, Medical Oncology, University of Kansas Medical Center
  
  Session: Breast Cancer - Local/Regional/Adjuvant
  
  Date / Time: Monday, June 2, 2025 | 9:00 AM – 12:00 PM CDT
  
  
  
  
• Molecular Insights into HR+/HER2+ Early-Stage Breast Cancer: Neoadjuvant Therapy Responses by MammaPrint and BluePrint genomic subtypes
  
  Author: Samijan, L., et al.
  
  Presenter: Adam Brufsky, MD, PhD, Professor and Associate Chief of Hematology and Oncology at UPMC Hillman Cancer Center
  
  Session: Breast Cancer - Local/Regional/Adjuvant
  
  Date / Time: Monday, June 2, 2025 | 9:00 AM – 12:00 PM CDT

More information about the program can be found at the 2025 ASCO Annual Meeting website.

About Agendia

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 treatment decisions for patients and their care teams. Their advanced genomic assays, MammaPrint^® + BluePrint^®, enable clinicians to quickly identify the most effective treatment plan, minimizing the risk of both under- and over-treatment.

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 – the world’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.

About MammaPrint

MammaPrint® is a gene expression profiling test that reveals the distinct underlying biology of an early-stage tumor to determine its risk of spreading. As the only FDA-cleared gene expression profiling test to assess a woman’s risk of distant metastasis, MammaPrint® provides critical answers that help inform the future of her treatment plan at the point of diagnosis, including the timing and benefit to chemotherapy and endocrine therapy. MammaPrint® listens to the signals from 70 key genes in a woman’s tumor to stratify her risk within four distinct categories – ranging from UltraLow, Low, High 1, and High 2– to fuel a right-sized care plan tailored to her biology and her life’s plans.

About BluePrint

BluePrint® is a gene expression profiling test that reveals the driving forces behind a tumor’s growth at the earliest stage possible in a woman’s breast cancer care journey to help optimize and personalize treatment planning. As the only molecular subtyping test available in the U.S., BluePrint® 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. BluePrint® measures the activity of 80 key genes that are involved in a tumor’s growth to classify a tumor as Luminal-type, HER2-type, or Basal-type, each of which warrant distinct treatment pathways. By revealing the distinct underlying biology of a woman’s tumor, BluePrint® can catch often misclassified, yet highly aggressive, Basal tumors, so women can be prescribed the most appropriate treatment from the start.

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