IRVINE, CALIF., U.S – 21 October 2020 – Agendia Inc., a world leader in precision oncology for breast cancer, announced today that the Federal Joint Committee (G-BA) has approved MammaPrint®, Agendia’s 70-Gene Breast Cancer Recurrence Assay. The G-BA decision to reimburse will broaden access to all breast cancer patients in Germany.
MammaPrint analyzes 70 genes most associated with breast cancer recurrence to provide a binary Low or High Risk of cancer recurrence result. This essential information helps breast cancer patients, and their doctors, to individualize how they manage their patients’ treatment regimen to minimize unnecessary treatment with chemotherapy, retain quality of life, and ensure the best possible outcomes.
Mark Straley, CEO of Agendia, commented, “We welcome the G-BA decision, as it gives more choice and flexibility to patients and health practitioners in Germany and enables the continued move towards precision oncology, where genomic testing is integrated into routine clinical practice for better shared decision making.”
In partnership with PathoNext and HiSS Diagnostics, Agendia recently launched in Germany the next-generation sequencing (NGS)-based MammaPrint® BluePrint® Breast Cancer Recurrence and Molecular Subtyping Kit to enable local testing. This CE-marked kit is an RNA-sequencing based version of the existing microarray-based MammaPrint and BluePrint tests. Now health care professionals in Germany have two options, either send samples to PathoNext’s laboratory in Leipzig or to Agendia’s laboratory for central testing via microarray.
Breast cancer is the most common cancer in women, affecting one in eight in Europe with 355,000 new cases per year. Approximately 70,000 women in Germany are diagnosed with early-stage breast cancer every year, and for about 20,000 [nearly 1/3] of them, treating physicians cannot recommend adjuvant chemotherapy based on clinical and pathology criteria alone. For those women, and their treating physicians, a biomarker test supports the decision-making-process. Identifying women who do not have significant benefit from chemotherapy yields a considerable quality-of-life benefit and cost benefits overall.
Agendia is a precision oncology company headquartered in Irvine, California, committed to bringing early stage breast cancer patients and their physicians the information they need to make the most effective treatment decisions. The company currently offers two commercially-available genomic profiling tests, supported by clinical and real world evidence. MammaPrint®, the 70-gene breast cancer recurrence assay, and BluePrint®, the 80-gene molecular subtyping assay, provide a comprehensive genomic profile and the data physicians need to make more informed decisions in the pre- and post-operative treatment settings. By developing evidence-based novel genomic tests and conducting groundbreaking research while building an arsenal of data that will help treat cancer, Agendia aims to improve patient outcomes and support the evolving clinical needs of breast cancer patients and their physicians every step of the way, from initial diagnosis to cancer-free.
For more information on Agendia’s assays and ongoing trials, please visit www.agendia.com.
Issued for and on behalf of Agendia by Instinctif Partners.
For more information please contact: Agendia@instinctif.com