Agendia's FLEX Study Reaches Enrollment of Over 17,000 Early-Stage Breast Cancer Patients Across Diverse Population

This achievement highlights the remarkable seven-year progression of FLEX and its many sub-studies highlighting the ethnic and racial nuances that may influence treatment pathways

Agendia, Inc. today announced that a diverse patient population of over 17,000 has been successfully enrolled in the FLEX Study, a prospective real-world evidence, whole transcriptome, observational breast cancer study (NCT03053193). The FLEX Study, which intends to enroll 30,000 patients, employs a patient-centric design to accelerate impactful data generation through a national network of participating sites. This approach encourages investigator-initiated sub-studies, providing robust analysis of diverse patient populations and supporting various research perspectives that, as a result, enhances the scope of the overall study.

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Since its launch seven years ago in April 2017, FLEX has enrolled patients across 100 sites in the US and around the world and has conducted over 40 sub-studies in several topics. FLEX has also created a comprehensive patient database with the potential to identify new gene associations with prognostic and/or predictive value in breast cancer. In addition to producing key information around early breast cancer (EBC) care, FLEX aims to address racial and ethnic disparities through its sub-studies. This concerted effort has led to more than 10 pieces of clinical evidence across both abstracts and publications assessing diversity. The study includes 1,377 self-identified Black, 530 Latin American/Hispanic, and 353 Asian and Pacific Islanders. These numbers make FLEX the most diverse study on EBC patients to date. Open to patients of all racial and ethnic backgrounds diagnosed with stage I, II, or III early-stage breast cancer, including all clinical subtypes, the dataset aims to be a true representation of the entire patient population. As a result of Agendia’s commitment to enroll a racially diverse patient population, the FLEX Study can be used to better understand differences in breast cancer biology due to genetic ancestry which may affect outcomes and helps to further support the Diversity Action Plans initiative, set forth by the FDA.

“Enrolling 17,000 patients in only seven years is an extraordinary milestone for the FLEX Study. It underscores the critical advancements being made in breast cancer research and the continued advancement of personalized treatment planning for patients across diverse, self-identified racial groups,” said Joyce O’Shaughnessy, MD, National Principal Investigator of the FLEX Study, Director, Breast Cancer Research, Baylor University Medical Center, Texas Oncology and the Sarah Cannon Research Institute in Dallas, TX. “Agendia, in partnership with clinicians and researchers from around the world, is spearheading the discovery and compilation of valuable data that have the potential to impact how early breast cancer patients receive treatment based on their specific biologic profile.”

About the FLEX Study

The FLEX Study is a large-scale, prospective, observational breast cancer study that links full genome profiling, including MammaPrint and BluePrint, with complete clinical data. FLEX has created a comprehensive patient database with the potential to identify new gene associations with prognostic and/or predictive value in breast cancer. The primary goal of this project is to capture genomic and clinical data for 30,000 breast cancer patients and to follow them for more than 10 years. Open to both women and men diagnosed with stage I, II, or III breast cancer, including all clinical subtypes, the dataset will be a true representation of the entire patient population. By capturing data from patients of all ethnicities, ages, genders, and health statuses, the FLEX database provides valuable opportunities to accelerate real-world breast cancer research.

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. Both assays are available for use in the diagnostic setting around the world.

Founded in 2003 in Amsterdam, Agendia is headquartered in Irvine, California with a state-of-the-art laboratory facility. 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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