Clinical Labs FAQs

Answers To Important Questions You May Have

Thanks for your interest in our MammaPrint BluePrint Kit. To find out more about how you can implement the MammaPrint BluePrint Breast Cancer Recurrence and Molecular Subtyping Kit in your lab, please contact Agendia Customer Service at [email protected] or by telephone at +31 (0) 20 462 1510, Monday through Friday from 08:30 to 17:00 (GMT/UTC +1).

The MammaPrint BluePrint Kit is available in select regions of the world. Contact an Agendia Customer Service representative for regional availability.

The MammaPrint BluePrint Kit is validated for use on the Illumina® MiSeq® or MiSeqDX® System (Illumina, SY-410-1003 or DX-410-1001).
The Kit includes the reagents for the preparation of targeted next-generation sequencing (NGS) libraries starting after RNA isolation from FFPE tissue, plus the probes needed to enrich the MammaPrint and BluePrint genes from the NGS fragment library.

The Kit does not include reagents required for RNA isolation or for sequencing. The QIAGEN RNeasy FFPE Kit (QIAGEN, 73504) must be used for the RNA isolation. For sequencing, the MiSeq Reagent Kit V3 (Illumina, MS-102-3001), MiSeq reagent cartridge and the MiSeq System must be used for this step.

Additional reagents not included but required in the Kit include:

Reagent Manufacturer, Catalog Number
RNA Isolation – RNeasy FFPE Kit QIAGEN, 73504
Actinomycin D From Streptomyces sp. (Sigma-Aldrich, A1410)
Dynabeads® MyOne™ Streptavidin T1 Invitrogen, 65601 or 65602
Agencourt AMPure XP Beckman Coulter Genomics, A63880 or A63881 or A63882
MiSeq Reagent Kit v3 Kit (150-cycle) Illumina, MS-102-3001
PhiX Control Kit V3 Illumina, FC-110-3001
Dimethyl sulfoxide Molecular biology grade (Sigma-Aldrich, D8418)
EB Buffer QIAGEN, 19086
Ethanol (EtOH), 100% Molecular Biology grade (VWR, 1085430250)
Tween 20 Non-ionic (Sigma-Aldrich, P7949)
Nuclease-free water Nuclease-free, deionized, no chemical additives (QIAGEN, 129114)
Sodium hydroxide (NaOH) 1N, Molecular Biology grade (Sigma-Aldrich, 72068)
Xylene Any available.
Histo-Clear National Diagnostics, HS-200

The letters ‘CE’ appear on many products traded on the extended Single Market in the European Economic Area (EEA) and are the abbreviation for “Conformité Européene.” The CE mark signifies that product conforms to safety, health, and environmental protection requirements. The MammaPrint BluePrint Kit carries the CE mark, confirming that the device has met all legal requirements and can be sold throughout the EEA.

Each MammaPrint BluePrint Kit has sufficient reagents to run 16 samples. The reagents are validated to be frozen and thawed up to five times.

The MammaPrint BluePrint Kit is composed of four boxes. Boxes need to be stored at either room temperature (Box 931282), -20°C (Boxes 931281 and 931283), or -80°C (Box 931284). The reagents are validated to be frozen and thawed up to five times.

To be able to run the test, FFPE tissue is required with at least 30% invasive tumor cells.

When needed and possible, a macro dissection can be performed to avoid large areas of in-situ carcinoma, necrosis, adipose tissue, stroma and/or hemorrhage as these will decrease the overall invasive tumor cell percentage.

The FASTQ files generated by the MiSeq sequencer will be processed by the Agendia Data Analysis Pipeline Tool (ADAPT). More detailed information can be found on the ADAPT section of this site.

The user will receive two documents per sample – the Technical Report and the Explanation of Results. The Technical Report will contain sample identification, quality control information and the MammaPrint BluePrint test results which include the MammaPrint Index (MPI), the determination of risk of recurrence (High Risk or Low Risk), and the BluePrint outcome (tumor subtype). The Explanation of Results provides an summary of the test results in the context of published clinical data.

More detailed information on results can be found in the package insert. The package insert is provided in Box 931282 and can also be found in the Resources section of this website.

The customer interaction with the ADAPT platform is secured through strong encrypted 1024-bit authentication and data transfer using the Agendia Service Connector. No patient identifiers are transmitted through the Agendia Service Connector. De-identified patient-related data is digitally signed, and monitored for authenticity.

Digital signing of genomic data files ensures immutability and authenticity throughout the data lifecycle.

The MammaPrint BluePrint Kit performs post-capture indexing. Samples are indexed during the post-capture PCR enrichment step, after the capture is performed. Our protocol performs capture on each sample separately (prior to indexing) which allows a higher accuracy/homogeneity of the capture reaction.

The Kit analyzes the same 70 genes for the MammaPrint test and the same 80 for the BluePrint test as is currently available only through the Agendia central lab services.

The length of time of time required to process a sample may vary from lab to lab. Typically, it takes about 5-7 days from isolation of RNA from FFPE tissue sample to results reporting.

The MammaPrint BluePrint Breast Cancer Recurrence and Molecular Subtyping Kit is intended for clinical laboratories experienced with next generation sequencing. In order to run the tests, laboratories must complete the Agendia Partner Reference Lab certification process.

If additional support or training is needed, please contact Agendia Customer Service at [email protected] or by telephone at +31 (0) 20 462 1510, Monday through Friday from 08:30 to 17:00 (GMT/UTC +1).

Please visit our Resources page on this website for more information on the MammaPrint BluePrint Kit or contact: Agendia Customer Service at [email protected] or by telephone at +31 (0) 20 462 1510, Monday through Friday from 08:30 to 17:00 (GMT/UTC +1).