September 28, 2019
Agendia Presents New Data on the Biological Characteristics of Patients within Extreme Low Risk and High Risk MammaPrint Subgroups at the European Society for Medical Oncology (ESMO)
IRVINE, CALIF., U.S., and AMSTERDAM, NETHERLANDS – 29 September 2019 – Agendia, Inc., a world leader in precision oncology for breast cancer, will present new data from their on-going clinical research at the European Society for Medical Oncology (ESMO) Congress 2019, taking place from September 27 to October 1 in Barcelona, Spain. The presentation, scheduled for September 29 at 12 noon, will focus on the biological characteristics of two cohorts of patients with early stage breast cancer at opposite ends of the recurrence risk spectrum: women at “Ultralow” and “Ultrahigh” risk for breast cancer recurrence.
One of the biggest challenges physicians face when treating patients with early stage, curable breast cancer is choosing a treatment path that will mitigate the risk of recurrence, while seeking to avoid overtreatment or undertreatment. “Agendia is committed to finding answers for such patients. For this reason, it is important to conduct studies like this to better understand the genomic basis of those breast cancers which are at the extremes of low and high risk, to provide greater precision in determining appropriate therapy,” stated William Audeh, MD, Chief Medical Officer of Agendia, Inc.
In this analysis, Agendia’s research team sought to identify the biological characteristics of two previously-identified subgroups of patients, those with Ultralow and Ultrahigh MammaPrint scores. Investigators employed differentially-expressed gene analysis (DEG) and gene set enrichment analysis (GSEA) to evaluate the full transcriptome data from 400 randomly chosen MammaPrint profiles. The Ultralow cohort was shown to have more homogeneous genomic profiles and enrichment of pathways favoring decreased proliferative and metastatic potential. The Ultrahigh cohort, on the other hand, demonstrated greater genomic heterogeneity with activation of pathways associated with more aggressive cancers, including those related to immune response, cell cycle regulation and DNA repair mechanisms.
“We are very excited to present these findings at ESMO,” commented Annuska Glas, PhD, Vice President R&D and Product Support. “This important insight into the biological processes of early-stage breast cancer may help physicians identify more effective treatment strategies.”
MammaPrint is an in vitro diagnostic medical device, performed as a testing service in a central laboratory, using the 70-gene expression profile of breast cancer tissue samples to assess a patient’s risk for distant metastasis within 5 years. The test is performed for breast cancer patients, with Stage I or Stage II disease, with tumor size ≤ 5.0 cm and lymph node negative. The device is FDA-cleared and CE-marked, enabling use in the European Union. MammaPrint is indicated for use by physicians as a prognostic marker only, along with other clinical-pathological factors. It is not intended to determine the outcome of disease, nor to suggest or infer an individual patient’s response to therapy. MammaPrint is the only test of its kind recommended for lymph node-negative and lymph node-positive patients by both the American Society of Clinical Oncology (ASCO) and National Comprehensive Cancer Network (NCCN®). The test is also recommended by many other national and international clinical practice guidelines.
Agendia is a privately-held, leading precision oncology company that develops and markets genomic diagnostic products, which help support physicians with their complex treatment decisions. Agendia’s breast cancer tests were developed using an unbiased gene selection by analyzing the complete human genome. The company’s offerings include the MammaPrint Breast Cancer Risk-of-Recurrence Test, and the BluePrint Molecular Subtyping Test, both on microarray technology, whereas the new MammaPrint BluePrint Breast Cancer Recurrence and Molecular Subtyping Kit, is on NGS technology. The MammaPrint BluePrint next-generation sequencing-based kit is a CE-marked device currently available for use in cancer centers in select regions of the world. In addition, Agendia has a pipeline of other genomic products in development. The company collaborates with pharmaceutical companies, leading cancer centers and academic groups to develop companion diagnostic tests in the area of oncology. For more information on Agendia or the MammaPrint and BluePrint tests, visit agendia.com. Follow Agendia, Inc. on Facebook, Twitter, or LinkedIn to keep up-to-date with the latest news.