Company Overview of Agendia N.V.
Agendia N.V. offers discovery, development, marketing, and commercialization of genomic-based diagnostic products to improve the quality of life for cancer patients by providing healthcare professionals with critical information to enable personalized treatment. It offers Symphony suite of molecular diagnostic breast cancer tests, such as TargetPrint, a microarray-based gene expression assay, which offers a quantitative assessment of the patient’s level of estrogen receptor, progesterone receptor, and HER2/neu gene within breast cancer tumor; and MammaPrint, a IVDMIA gene expression breast cancer assay that provides physicians with the ability to identify which early-stage breast cancer pati...
Science Park 406
Founded in 2003
Key Executives for Agendia N.V.
Chief Executive Officer and Member of Supervisory Board
Co-Founder and Chief Research Officer
Co-Founder and Chief Scientific Officer
Chief Financial Officer and Vice President of Finance
Vice President of Regulatory Affairs and EU Market Access
Compensation as of Fiscal Year 2015.
Agendia N.V. Key Developments
Agendia’s BluePrint Molecular Subtyping Assay Highlighted at the 32nd Annual Miami Breast Cancer Conference
Mar 4 15
Agendia announced new data from an ongoing study indicates the BluePrint® functional molecular subtyping assay more accurately identifies molecular subgroups and may be a better guide for neoadjuvant treatment than standard, local IHC/FISH assays. The aim of the prospective NBRST study is to compare functional molecular subtyping by BluePrint/MammaPrint® to conventional local IHC/FISH subtyping to predict chemosensitivity as defined by pathologic complete response (pCR). Agendia’s BluePrint 80-gene Molecular Subtyping Assay is the most widely available test providing the functional molecular subtype of a woman’s breast cancer. BluePrint is performed on formalin-fixed paraffin-embedded (FFPE) tissue and is part of Agendia’s suite of breast cancer assays that also includes the MammaPrint 70-gene Risk of Recurrence assay, which recently received FDA 510(k) clearance for use in FFPE tissue samples. MammaPrint was the first breast cancer risk of recurrence multi-gene assay to receive FDA 510(k) clearance. With the most recent clearance, Agendia now has six FDA clearances in its breast cancer portfolio.
Agendia Receives New FDA Clearance for MammaPrint FFPE Breast Cancer Test
Feb 10 15
Agendia announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the company's MammaPrint® breast cancer recurrence test in FFPE (formalin-fixed paraffin embedded) tissue. The MammaPrint FFPE test utilizes the same 70 genes and proprietary algorithm as the previously cleared MammaPrint Fresh, the first multi-gene medical device to ever receive a 510(k) FDA clearance. Due to the larger panel of genes than any other commercially available test, both tests provide an unambiguous result of Low vs. High risk for recurrence of a patient s breast cancer. This capability surpasses all other commercially available tests because it applies across all age groups, and is not restricted by estrogen or HER 2 receptor status. This additional insight about the cancer's biology enables physicians to appropriately choose the best treatment for their patients. MammaPrint FFPE changes the conversation between physicians and patients at that critical point where treatment decisions are being made. The test result eliminates the ambiguity of the Intermediate result seen in other test platforms, and in concert with other factors, facilitates a decision by both patients and physicians about the relative benefit of chemotherapy and endocrine therapy. The MammaPrint FFPE 510(k) clearance not only confirmed the robust accuracy, repeatability and reproducibility of the original 70 gene signature, but it also confirmed the clinical performance of the signature using the results of the first ever five-year clinical outcome study (RASTER) in which MammaPrint results were utilized by physicians to decide post-surgical management. In that real-world study, patients were treated according to the best standard of care. Patients with a Low Risk MammaPrint score had a 97.7 % probability of being cancer free at five years, while those with a High Risk score had an 88.5% probability of being cancer free. In a univariate analysis against other clinical pathologic factors, MammaPrint's prognostic value is highly statistically significant (P=0.002).
Agendia, Inc. Announces Executive Changes
Oct 2 14
Agendia Inc. announced the appointment of life science industry veteran and Agendia board member Jan H. Egberts, M.D., as CEO. He replaces David Macdonald, who has left the company to pursue other opportunities. Dr. Egberts served most recently as CEO of OctoPlus.
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