IRVINE, CALIF., U.S., and AMSTERDAM, NETHERLANDS – 20 June 2019 – Agendia, Inc., a world leader in precision oncology, announced today the open access publication of MammaPrint and BluePrint Molecular Diagnostics using targeted RNA Next-Generation Sequencing technology in the Journal of Molecular Diagnostics. The publication summarized the analytical and clinical validation studies of MammaPrint® and Blueprint® using RNA Next-Generation Sequencing (NGS) –based technology to perform diagnostic testing.
The original microarray technology-based MammaPrint, which has extensive clinical validation, uses the proprietary, 70-gene expression profile to classify patients with breast cancer as having a “low” or “high” risk of recurrence over a period of 10 years. Similarly, the original BluePrint assay was microarray technology based, and provides critical subtyping information to further enhance treatment approaches. Oncologists and breast surgeons use the information provided by MammaPrint and BluePrint to help guide overall treatment strategy for patients diagnosed with early stage breast cancer.
The authors of this study evaluated the use of RNA-seq as a de-centralized methodology to perform MammaPrint and BluePrint. Validation experiments were performed to assess the technical and clinical performance equivalence of the MammaPrint and Blueprint NGS test compared to the diagnostic microarray test; its reproducibility between different samplings of the same tumor, over-time and between different laboratories. Concordance of over 97% was observed between results obtained using NGS and microarray technologies.
The clinical performance of the MammaPrint and BluePrint 150-gene NGS test was independently assessed in a set of samples with known clinical outcome, previously used to validate the clinical utility of the MammaPrint microarray-based diagnostic test. The data demonstrated that RNA-seq can be used as a de-centralized platform for MammaPrint and BluePrint. This validation will allow Agendia to expand on the company’s existing NGS strategy and to focus on growing the base of customers in Europe and Asia who employ the decentralized proprietary testing.
Franklin Libenson, MD, Agendia Executive Vice President of NGS Strategy and Market Development, said: “We are very pleased to have published this important study, which will make MammaPrint and BluePrint available to thousands more women around the globe, and will continue to help physicians to clarify the complexity of overall early-stage breast cancer treatment strategy.”
Agendia is a privately-held, leading precision oncology company that develops and markets 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. The company’s offerings include the MammaPrint Breast Cancer Risk-of-Recurrence Test, and the BluePrint Molecular Subtyping Test, both on microarray technology, whereas the new MammaPrint BluePrint Breast Cancer Recurrence and Molecular Subtyping Kit, is on NGS technology. The MammaPrint BluePrint next-generation sequencing-based kit is a CE-marked device currently available for use in cancer centers in select regions of the world.
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 on Agendia or the MammaPrint and BluePrint tests, visit agendia.com. Follow Agendia, Inc. on Facebook, Twitter, or LinkedIn to keep up-to-date with the latest news.
MammaPrint is an in vitro diagnostic medical device, performed as a testing service in a central laboratory, using the 70-gene expression profile of breast cancer tissue samples to assess a patient’s risk for distant metastasis within 5 years. The test is performed for breast cancer patients, with Stage I or Stage II disease, with tumor size ≤ 5.0 cm and lymph node negative. The device is FDA-cleared and CE-marked, enabling use in the European Union. MammaPrint is indicated for use by physicians as a prognostic marker only, along with other clinical-pathological factors. It is not intended to determine the outcome of disease, nor to suggest or infer an individual patient’s response to therapy. MammaPrint is the only test of its kind recommended for lymph node-negative and lymph node-positive patients by both the American Society of Clinical Oncology (ASCO) and National Comprehensive Cancer Network (NCCN®). The test is also recommended by many other national and international clinical practice guidelines.
BluePrint is an 80-gene complementary gene expression test provided with MammaPrint which allows functional molecular subtyping of a breast cancer sample into three distinct subtypes: Luminal-type, HER2-type and Basal-type, each with marked differences in long-term outcome and response to neoadjuvant chemotherapy.