CA-AGENDIA

Agendia, Inc. , a 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, today announced new data published in Genes, Chromosomes and Cancer (Genes) that show MammaPrint^® and BluePrint^® gene signatures represent and capture all of the original 10 hallmarks of cancer (HoCs), recognized as the biological capabilities acquired during the multi-step development of human cancer, as defined by Hanahan and Weinberg.^1,2

Previous data demonstrated the association of the 70 MammaPrint genes with the initial six HoCs, which represent characteristics acquired during the multistep development of cancer cells to survive, proliferate, disseminate, and metastasize.³ In updating the annotation of MammaPrint and BluePrint genes related to the subsequently established HoCs, the data published in Genes underscores the biological relevance in, and the comprehensive nature of, the MammaPrint signature extending beyond tumor proliferation genes.

“This study further unlocks new insights that MammaPrint and BluePrint are accurately aligned with the 10 hallmarks of cancer, which are considered the underlying biological processes,” said Frédérique Penault-Llorca, MD, PhD, Professor of Pathology in the Department of Pathology and Molecular Pathology, Centre Jean Perrin, Clermont-Ferrand, France. “With this validation, the updated annotations show the clinical utility of MammaPrint and BluePrint as comprehensive genomic tools to provide more precise insights for women with breast cancer.”

Additionally, the peer-reviewed data highlights MammaPrint’s ability to further stratify High Risk breast cancer tumors based on their underlying biological processes into High 1 or High 2 sub-groups, offering physicians more specific insights as they guide treatment decisions for women with early-stage breast cancer. Previous data from the ISPY trial demonstrated that MammaPrint can identify separate High 1 and High 2 sub-groups, with different responses to treatment. These data show that the High 2 Risk sub-group is biologically different from High 1 but also from the other extreme end of the spectrum: Ultra Low. The biological features may explain differences in the prognosis and therapy responses of these tumors. Through the discovery and validation of more specific stratifications in the High Risk category, providers can more precisely treat these biologically differentiated tumors that have higher pathologic response rates to treatment combinations, including chemotherapy and immunotherapy.

“This latest study illustrates with elegant biology, the comprehensive nature of the genomic information provided by MammaPrint and BluePrint. It also confirms our expectation that the MammaPrint High Risk category further identifies clinically important distinctions in breast cancer biology, reflecting the evolving knowledge in the field,” said William Audeh, MD, Chief Medical Officer at Agendia. “These findings highlight today’s opportunity to stratify MammaPrint signatures beyond Low and High Risk, which allows patients and physicians to better understand the genomic complexity of breast cancer and provides new insights at the time of diagnosis that may impact the course of treatment.”

Agendia is committed to continuing research to validate additional datasets evaluating the precise tumor stratification by MammaPrint and molecular subtyping by BluePrint to inform refined, personalized treatment planning decisions for women with breast cancer and their providers.

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 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 .

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¹ Haan JC, Bhaskaran R, Ellappalayam A, Bijl Y, et al. MammaPrint and BluePrint comprehensively capture the cancer hallmarks in early-stage breast cancer patients. Genes, Chromosomes and Cancer. Published online 2021. doi:10.1002/gcc.23014
² Hanahan D, Weinberg RA. Hallmarks of cancer: The next generation. Cell . Published online 2011. doi:10.1016/j.cell.2011.02.013
³ Tian S, Roepman P, van’t Veer LJ, Bernards R, de Snoo F, Glas AM. Biological functions of the genes in the mammaprint breast cancer profile reflect the hallmarks of cancer. Biomark Insights . Published online 2010. doi:10.4137/BMI.S6184

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