IRVINE, CALIF., U.S – 6 October 2020 – Agendia Inc., a world leader in precision oncology for breast cancer, announced today the availability of local testing for its CE-marked MammaPrint® BluePrint® Breast Cancer Recurrence and Molecular Subtyping tests, provided by PathoNext lab in Leipzig, Germany. Breast cancer patients in Germany will now have access to state-of-the art genomic profiling in their own country.
The trend towards precision oncology ensures that more physicians than ever before are integrating genomic testing into their routine clinical practice. This essential information helps them to truly individualize how they manage their patients’ treatment regimen to minimize unnecessary treatment, retain quality of life and ensure the best possible outcomes.
MammaPrint analyzes 70 genes most associated with breast cancer recurrence to provide a binary Low or High Risk of cancer recurrence result, while BluePrint analyzes 80-genes which classify a patient’s breast cancer into functional molecular subtypes. These tests have historically been perfomed via microarray at Agendia’s laboratory in Irvine, California, and Agendia continues to provide a centralized testing service.
However, more and more countries request local testing for reimbursement of tests. To address the specific need for testing in other countries outside of the Agendia central laboratory, the next-generation sequencing (NGS)-based MammaPrint® BluePrint® Breast Cancer Recurrence and Molecular Subtyping Kit has been developed. This CE-marked kit is an RNA-sequencing based version of the existing microarray-based MammaPrint and BluePrint tests. Analytical and clinical validity of the NGS-kit have been demonstrated and published in peer-reviewed journals.
PathoNext in Germany will partner with Agendia to run the tests and co-partner with HiSS, Agendia’s distributor in Germany. PathoNext will leverage its existing infrastructure to run MammaPrint and BluePrint in its own labs, using NGS instruments to analyze patient samples. HiSS covers a broad range of specialties, including oncology and cell biology. Both companies will work together to offer patients in Germany access to MammaPrint and BluePrint testing.
Mark Straley, CEO of Agendia, commented, “We are very pleased to have our NGS-kit available in the German market. We are confident that PathoNext will deliver the same high-quality performance as they do with their other tests. Together, we will bring Agendia’s high-quality testing to the nearly 25,000 women annually diagnosed with breast cancer in Germany.”
Breast cancer is the most common cancer in women, affecting one in eight in Europe with 355,000 new cases per year. The quality-of-life and cost benefits of identifying women who may not have significant benefit from chemotherapy are considerable. Providing both centralized and decentralized testing options increases patient access to the MammaPrint and BluePrint tests.
Prof. Dr. Jörg Gabert, CEO of PathoNext, added, “With the growing breast cancer burden globally, and increasing incidence of diagnoses, Agendia’s MammaPrint and BluePrint are a perfect complement to our molecular pathology division. We are pleased to help breast cancer patients, both in obtaining an appropriate diagnosis, and in the choice of a fully personalized treatment.”
PathoNext GmbH is a biotechnology company which specializes in the new techniques of high throughput DNA sequencing. They are generally summarized under the term next-generation sequencing (NGS). The methods are used to identify genetic changes for the detection of relevant point mutations, insertions, deletions, translocations and microsatellite instabilities and revolutionized wide areas of pathology and oncology. Diseases can be better differentiated using NGS and the therapeutic success of medication – for example in the case of tumor diseases – can be better assessed.
In addition, PathoNext is concerned with the bioinformatic evaluation of big data and the development of special gene panels for reliable detection of genetic changes. The company is accredited according to DIN ISO 17025. For information about PathoNext please visit www.pathonext.de.
HiSS Diagnostics GmbH in Freiburg, Germany with 30 years of experience as a trusted supplier of diagnostics products for oncology and molecular biology and is a long-standing distribution partner of Agendia. Previously a competent advisor for German patients regarding the realization of MammaPint and BluePrint Tests, HiSS was looking for a suitable laboratory to perform the tests within Germany and found a competent partner in PathoNext. Thus, the legal requirements for reimbursement are met. HiSS Diagnostics is accredited according to ISO 13485:2016. For more information about HiSS Diagnostics please visit www.hiss-dx.de.
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.
Agendia NV Amsterdam
Mrs. Corafien Kuck-Baas, MSc.
Instinctif Partners (European media relations)
Tim Watson / Siobhan Sanford
Tel: +44 (0) 20 7457 2020