IRVINE, Calif. & AMSTERDAM–(BUSINESS WIRE)–Agendia, Inc., a leader in gene expression profiling for early-stage breast cancer, received acceptance for all six abstract submissions that will help guide the future of personalized cancer care and will be presented at the 2022 San Antonio Breast Cancer Symposium (SABCS). These studies focus on the impact of MammaPrint and BluePrint test results, unveiling the underlying biology of a breast cancer patient’s unique tumor to help inform more personalized treatment decisions. The data reaffirm Agendia’s commitment to driving the science behind early-stage breast cancer, so women and their providers have access to an accurate assessment of the tumor’s risk of metastasizing, and of which molecular pathway is driving that tumor’s growth. These informative insights come from Agendia’s proprietary signature derived directly from the tumor’s biology and go beyond conventional methods.

Three of the studies Agendia will present are based on its FLEX trial, the largest real-world evidence database of patients with early-stage breast cancer. With over 10,000 patients enrolled, the FLEX trial allows researchers to conduct sub-studies in parallel to uncover new genomic trends and produce practice-changing results that can improve the lives of women. Because many breast cancer trials lack the diversity needed to adequately inform clear guidance on treatment recommendations for minority groups, FLEX’s inclusion of both genomic data and clinical data across a true representation of the population allows for a critical focus on the needs of diverse, marginalized patient groups.

“The value of unbiased genomic data lies in tailoring treatment plans for each individual tumor with unprecedented precision. The research derived from our FLEX trial is a key example of the type of advancements in breast cancer Agendia is helping to fuel. These critical discoveries will improve the future of personalized care for all women with breast cancer, including those who are often underrepresented in genomic studies,” said William Audeh, MD, Chief Medical Officer at Agendia.

Agendia’s Spotlight Poster will showcase one such sub-study on Wednesday, December 7^th at 5pm CT, “ImPrint immune signatures in 10,000 early-stage breast cancer patients from the real-world FLEX database.” Dr. Adam Brufsky, Professor and Associate Chief of Hematology and Oncology at UPMC Hillman Cancer Center will present research that found Agendia’s 53-gene signature ImPrint® test identified women who may benefit from immune therapy, supporting the potential use of checkpoint inhibitors, especially among populations who are underrepresented in clinical trials, including pre-menopausal patients, Black and Latina women.

Additional research areas where Agendia is advancing breast cancer research will be presented through the following FLEX sub-studies:

• “FLEX: 30K transcriptome, real-world evidence database for early-stage breast cancer and investigator initiative protocols,” presented on Wednesday, December 7^th at 5pm CT, by Dr. Alejandra Perez, a medical oncologist from the University of Miami Hospital. Dr. Perez and the FLEX Investigators will detail the methods behind building the FLEX registry and highlight its impact on fast data generation for underserved research areas and on advancing widespread understanding of tumor biology.
• “Impact of neoadjuvant endocrine therapy on tumor transcriptome in patients with early-stage breast cancer from the FLEX trial,” presented on Thursday, December 8^th at 5pm CT, by Dr. Mehran Habibi, Associate Professor of Surgery at Johns Hopkins University. This study evaluated the genomic effect of short-term neoadjuvant endocrine therapy (NET) in early-stage breast cancer tumors and discovered MammaPrint test results can predict patient response within a shorter timeframe than the several months it typically takes to observe immediate genomic changes.

“As the amount of robust gene expression profiling data available for research grows, so does its influence on the way we treat early-stage breast cancer tumors, and on the outcomes of millions of women with breast cancer seeking evidence-based, personalized care plans,” said Dr. Adam Brufsky. “By opening up a world of data that otherwise would have been nearly impossible to gather via traditional trial recruitment, we grow our collective understanding of tumor biology and can give patients the confidence they need to trust our treatment planning decisions.”

In addition to research from the FLEX database, the following three presentations will help inform personalized treatment decisions:

• “Utility of the 70-gene signature and 10-year follow up in patients with early-stage breast cancer in a single institution study,” presented on Thursday, December 8^th at 7am CT, by Dr. Nasrazadani, Assistant Professor in the Department of Breast Medical Oncology at The University of Texas MD Anderson Cancer Center, and Dr. Adam Brufsky. The presentation will detail findings of a retrospective analysis of women with early-stage breast cancer whose treatment plans may have changed if they had a MammaPrint test result.
• On Thursday, December 8^th at 10am CT in the Exhibit Product Theater, Dr. William Audeh will address leaders in oncology and highlight recent data in the Journal of Clinical Oncology that supports Agendia’s proven gene expression profiling tests can help inform the most effective treatment approaches for a woman’s unique cancer, regardless of age and menopausal status..
• “Utility of the 70-gene MammaPrint test for prediction of extended endocrine therapy benefit in patients with early-stage breast cancer in the IDEAL Trial,” presented on Friday, December 9^th at 12pm CT, by Dr. Laura van’t Veer PhD, Professor Laboratory Medicine and Director Applied Genomics at the Cancer Center at UCSF and Founder of Agendia. During this oral presentation, Agendia will discuss the breakthrough findings uncovered by the IDEAL study and reiterate the impact of MammaPrint test results in identifying which post-menopausal women could benefit from extended endocrine therapy. The presentation will also share what these findings mean for the future of breast cancer care, most notably the ability to identify patients who can avoid overtreatment if there will be little predicted benefit.

To learn more about Agendia’s solutions being showcased at booth #315 at SABCS, visit https://agendia.com/our-tests/. Follow Agendia on Twitter, Facebook and LinkedIn for updates throughout the conference.

About Agendia

Agendia is a mission-driven, commercial stage company focused on enabling optimized decision-making by providing physicians with next-generation diagnostic and information solutions that can be used to help improve outcomes for breast cancer patients worldwide. The company currently offers two commercially-available genomic profiling tests that help surgeons, oncologists and pathologists to personalize treatment for women at critical intervention points throughout their patient journey.

MammaPrint^® is a 70-gene prognostic test that, along with other clinicopathologic factors, determines a specific patient’s breast cancer recurrence risk. BluePrint^® is an 80-gene molecular subtyping test that identifies the underlying biology of an individual breast cancer to provide information about its behavior, long-term prognosis and potential response to systemic therapy. Together, MammaPrint^® and BluePrint^® provide a holistic view of the biology underlying an individual patient’s breast cancer, enabling physicians to objectively select the best treatment plan.

For more information on Agendia’s assays and ongoing trials, please visit www.agendia.com.