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Tuesday, October 26, 2021


HomeGenomic Diagnostic ProductsPublication of Study Validating Use of MammaPrint and BluePrint Molecular Diagnostics using...

Publication of Study Validating Use of MammaPrint and BluePrint Molecular Diagnostics using Targeted RNA Next-Generation Sequencing Technology

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.”

Medical Device News Magazine
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

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