Precision oncology company Agendia, Irvine, Calif, says that a new study validates the use of RNA-seq as a decentralized methodology at the core of its MammaPrint and BluePrint microarray-based diagnostic technology.1

MammaPrint uses a 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 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.


Franklin Libenson, MD, Agendia.

The authors of the study evaluated the use of RNA-seq as a decentralized methodology to perform MammaPrint and BluePrint testing. Validation experiments were performed to assess the technical and clinical performance equivalence of the MammaPrint and Blueprint next-generation sequencing (NGS) tests compared with the diagnostic microarray test. The experiments assessed reproducibility among different samplings of the same tumor, over time, and across different laboratories. Concordance of more than 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 using a set of samples with known clinical outcomes, 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 decentralized platform for MammaPrint and BluePrint.

Results of the validation study will allow Agendia to expand on its existing NGS strategy and to focus on growing its base of customers in Europe and Asia who employ the decentralized proprietary testing.

Franklin Libenson, MD, Agendia’s executive vice president for NGS strategy and market development, says the study results “will make MammaPrint and BluePrint available to thousands more women around the globe.”


  1. Mittempergher L, Delahaye LJMJ, Witteveen A, et al. MammaPrint and BluePrint molecular diagnostics using targeted RNA next-generation sequencing technology. J Mol Diagn. Epub ahead of print, June 4, 2019; doi: 10.1016/j.moldx.2019.04.007.