IRVINE, Calif. & AMSTERDAM—Earlier this summer, Agendia Inc., a global player in precision oncology, announced the open-access publication of MammaPrint and BluePrint Molecular Diagnostics using targeted RNA next-generation sequencing (NGS) technology in the Journal of Molecular Diagnostics. The publication summarized the analytical and clinical validation studies of MammaPrint and Blueprint using RNA 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-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 decentralized 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, and its reproducibility between different samplings of the same tumor, over time and between different laboratories. Concordance of over 97 percent 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. 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.
