- The “BRIDGE” initiative offers German patients free access to Agendia’s MammaPrint® breast cancer recurrence assay
- Data from the MINDACT trial shows MammaPrint is the only test on the German market supported by the highest level of medical evidence (1A)
IRVINE, CA and AMSTERDAM, 26 October 2016 – Agendia, Inc., a world leader in personalized medicine and molecular cancer diagnostics, announces the expansion of its business activities in Germany. The Company has launched the “BRIDGE” patient initiative to enable more physicians and their patients to access the additional benefits of its MammaPrint test.
MammaPrint is a 70-gene breast cancer recurrence assay that helps predict clinical outcome in women with early-stage breast cancer, identifying patients who are unlikely to benefit from chemotherapy to spare them from suffering unnecessary side effects and toxicity. Although gene expression tests are not yet part of the standard services provided by the statutory healthcare insurance providers in Germany, the BRIDGE program enables patients to gain free access to the MammaPrint test. The initiative is being run by Agendia in cooperation with Palleos Healthcare GmbH which is managing patient applications and reimbursement of the MammaPrint test under the program.
As part of the expansion of its business activities in Germany, and to support the “BRIDGE” initiative, Agendia also announces that it has strengthened its commercial team with the appointment of Hans-Jürgen Hartmann as Sales Manager, DACH.
The outcome of the prospective MINDACT trial published in the New England Journal of Medicine positions MammaPrint as the only gene expression test on the German market supported by highest level of medical evidence (1A). This is proof of the clinical benefits of the test for clearly determining the distant metastasis risk in patients with early-stage breast cancer, giving physicians confidence in making treatment decisions.
“The highest level of clinical data from the MINDACT means that doctors and patients can trust in the prognosis delivered by MammaPrint. The test has the potential to revolutionize clinical practice for the treatment of breast cancer, providing crucial additional information to enable doctors to coordinate their individual treatment plans. This is an important step in personalized medicine,” says Dr Marion Wasmayr, Business Development Manager DACH at Agendia.
Hans-Jürgen Hartmann, Sales Manager DACH, will focus on providing support to physicians in German-speaking countries for MammaPrint. He has 20 years’ experience in a variety of roles within the pharmaceutical industry at companies including Pfizer, Quintiles Commercials and Marvecs. Hans-Jürgen has previously been responsible for numerous product launches, primarily for products with indications in the fields of oncology and gynaecology.
“Hans-Jürgen Hartmann strengthens our team as a proven expert on the European oncology market. He will play a significant role in the market launch of MammaPrint in German-speaking countries,” says Dr Marjolaine Baldo, Commercial Vice President EMEA at Agendia.
MammaPrint is a FDA-cleared in vitro diagnostic test, available from FFPE sample, performed in a single laboratory, using the gene expression profile of breast cancer tissue samples to assess a patients’ risk for distant metastasis. The MammaPrint result is indicated for use by physicians as a prognostic marker only, along with other clinical-pathological factors. MammaPrint is not intended for diagnosis, or to predict or detect response to therapy, or to help select the optimal therapy for patients. Results should be taken in the context of other relevant clinical-pathological factors and standard practice of medicine.
Agendia is a privately held, leading molecular diagnostics company that develops and markets FFPE-based 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. Our offerings include the FDA-cleared MammaPrint FFPE 70-gene breast cancer recurrence assay as well as BluePrint®, a molecular subtyping assay that provides deeper insight leading to more clinically actionable breast cancer biology. These tests can help physicians assess a patient’s individual risk for metastasis – that is, which patients are more sensitive to chemo, hormonal, or combination therapy, and which patients may not require these treatments and which patients may be treated with other, less arduous and costly methods.
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, visit www.agendia.com
Dana Garbe / Daniel Gooch / Léon Melens (EU media)
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