Agendia Announces First Patient Enrolled in DEBRA Trial Using MammaPrint®

MammaPrint 70-gene signature to aid in evaluation of de-escalation of radiation therapy in Stage I, Hormone Sensitive, HER2-Negative breast cancer

Agendia^®, Inc., announced today that the first patient to use MammaPrint^® as an enrollment biomarker for the DEBRA Trial is to be enrolled. The Phase III NRG Oncology De-Escalation of Breast Radiation (DEBRA) Trial (NCT04852887) is a clinical study looking at safely reducing the use of breast radiation after lumpectomy for people with low-risk, early-stage breast cancer.

The DEBRA trial will seek to determine if, in comparison to the usual treatment of breast radiation and hormonal therapy, a more conservative treatment of hormonal therapy alone is as effective in women with low-risk, early-stage, hormone-sensitive breast cancer who have had a lumpectomy. The use of MammaPrint in this study will build on researchers’ work to identify tailored treatment paths, in this case redefining the standard of care that breast conservation must require both lumpectomy and radiotherapy.

“I am thrilled to be offering this trial to patients with Low Risk MammaPrint because the more we learn about tumor biology, the less likely we are to overtreat women with breast cancer,” said Eric Brown, MD, FACS Breast Surgeon, Comprehensive Breast Care, A Division of Michigan Healthcare Professionals, the center which enrolled the first patient for this study using MammaPrint. “Ultimately, we hope that this trial will allow the 70 gene assay to determine benefit of radiation in addition to its current utilization in defining the benefit of chemotherapy and length of endocrine therapy.”

MammaPrint is a 70-gene expression profile that reveals the distinct underlying biology of an early-stage tumor to determine its risk of recurrence. A MammaPrint Low Risk result is now used as a biomarker for enrollment criteria to the DEBRA study.

“The Michigan Health Professionals Team is excited to offer our patients personalized care by tailoring radiation treatment based on their unique tumor biology,” said Vito Antonucci, MD, Radiation Oncologist, Michigan Healthcare Professional’s Radiation Oncology Institute, a center participating in the DEBRA Trial. “Utilization of genomic testing (MammaPrint) has been key in treatment planning for early stage breast cancer patients for many years, and we look forward to exploring additional clinical utility in the management of our patients by optimizing our approach to delivering radiation therapy.”

“De-escalation of therapy is critical to improving the care of patients with low-risk, early-stage breast cancer, based on insights gained from gene expression profiling,” said William Audeh, MD, MS, Chief Medical Officer of Agendia. “With the first patient of this study being enrolled using MammaPrint, we look forward to participating in the development of a new path towards more precise, proactive treatment planning for early-stage breast cancer.”

To learn more about the DEBRA Trial and enrollment criteria, visit www.nrgoncology.org/DEBRA-Trial. For more information about Agendia, visit www.agendia.com and follow Agendia on Facebook, Twitter, YouTube, and LinkedIn.

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.

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. This FDA-cleared gene expression profiling test assesses a woman’s risk of distant metastasis and provides critical answers that inform the future of treatment plans 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.

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