IRVINE, CA and AMSTERDAM, 5 December 2016 – Agendia, Inc., a world leader in personalized medicine and molecular cancer diagnostics, notes the recommendation of Germany’s Institute for Quality and Efficiency in Healthcare (IQWiG) to delay approval of reimbursement of gene expression-based breast cancer tests by the Federal Joint Committee (G-BA), including Agendia’s 70-Gene Breast Cancer Recurrence Assay MammaPrint®.
Bastiaan van der Baan, Chief Clinical and Business Development Officer at Agendia said: “It is disappointing to hear that IQWiG has decided not to recommend the reimbursement of gene expression-based tests for breast cancer recurrence. Of four tests considered by IQWiG, MammaPrint was the only one fully assessed due to the high level of clinical evidence that underpins its performance, so we are surprised to receive this recommendation.
“MammaPrint has the potential to benefit tens of thousands of women with early stage breast cancer in Germany, sparing many from the toxicity and side effects of unnecessary chemotherapy. We are committed to ensuring that MammaPrint is available to support patients and their physicians in Germany and will continue to work alongside IQWiG to provide any further evidence to help support a positive recommendation.
“It is expected that the G-BA will publish their decision on the reimbursement of genomic assays after due and balanced consideration of all relevant aspects of the IQWiG report, written statements and an oral hearing, later this month. Agendia is confident that the G-BA will take a more flexible, patient-oriented approach to their decision making process which considers both the proven clinical benefit of MammaPrint and highest level of evidence of the test’s performance, provided by the landmark MINDACT trial.”
MammaPrint is a gold-standard gene expression-based breast cancer recurrence test. It remains included in numerous European guidelines for best-practice cancer treatment, such as the European Society for Medical Oncology (ESMO) and the St. Gallen Consensus Guidelines.
The MINDACT trial included almost 7,000 patients (over 800 from Germany), across 112 institutions in nine different European countries. Furthermore, the trial was designed in collaboration with leading physicians across Europe with consensus agreement that clinically utility for MammaPrint would be established if the trial met its primary end point. Positive outcome of the prospective trial was published in the New England Journal of Medicine in August this year. Participation from Germany included the West German Study Group and oversight from the German Federal Institute for Drugs and Medical Devices.
Agendia will continue to support women in Germany with access to the MammaPrint test via its “BRIDGE” initiative, run in cooperation with Palleos Healthcare GmbH which manages patient applications and reimbursement of the MammaPrint test within the program.
Agendia’s official statement regarding the IQWiG assessment can be found here: http://www.agendia.com/response-to-iqwig-assessment/
The IQWiG announcement can be found here (in German): https://www.iqwig.de/de/presse/pressemitteilungen/pressemitteilungen/biomarker-tests-bei-brustkrebs-entscheidung-uber-chemotherapie-bleibt-schwierig.7700.html
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
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