March 02, 2015 1:08 AM ET

Biotechnology

Company Overview of Agendia N.V.

Company Overview

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

Amsterdam,  1098XH

Netherlands

Founded in 2003

100 Employees

Phone:

31 20 462 1500

Fax:

31 20 462 1505

Key Executives for Agendia N.V.

Chief Executive Officer and Member of Supervisory Board
Age: 54
Co-Founder and Chief Research Officer
Age: 57
Co-Founder and Chief Scientific Officer
Age: 61
Chief Financial Officer and Vice President of Finance
Age: 49
Vice President of Regulatory Affairs and EU Market Access
Age: 45
Compensation as of Fiscal Year 2014.

Agendia N.V. Key Developments

Agendia Receives New FDA Clearance for MammaPrint FFPE Breast Cancer Test

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

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.

Agendia and CBLPath, Inc. Announce Agreement to Assist Physicians in Diagnostic Assessment of Breast Cancer

Agendia and CBLPath, Inc. announced that they have agreed to collaborate in providing molecular diagnostics testing to breast cancer patients. The collaboration is expected to advance the availability of personalized medicine and to benefit both physicians who treat breast cancer and women who have the disease.

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