Sysmex Europe

RNXtract® for MammaTyper®

RNXtract® Nucleic Acid Extraction Kit 

RNXtract® is intended for routine clinical use for extraction and purification of total RNA from formalin-fixed and paraffin-embedded (FFPE) sample material. 

The kit offers a reliable and robust method of gaining high-quality, amplifiable template RNA from formalin-fixed, paraffin-embedded (FFPE) tissue for use in subsequent molecular biology techniques. 

The kit contains eight vials of reagents that allow 48 extractions and was developed together with MammaTyper®

More details

Graphical Representation of the Procedure

RNXtract® Nucleic Acid Extraction Kit overview:

  • The RNXtract® Nucleic Acid Extraction Kit purifies nucleic acid from FFPE samples by using lysis buffer and proteinase K sequentially. 
  • The unique binding buffer system of this kit allows magnetic beads to bind nucleic acid efficiently and specifically. 
  • The washing system effectively removes proteins, nucleases and other impurities to provide highly purified and stable nucleic acid. 
  • This method does not use a deparaffinization reagent and is therefore considered friendly to the environment and safer for users.
  • The method does not require plastic columns for purification, which prevents the loss of nucleic acids during purification steps.

Technical specifications
Feature RNXtract® Nucleic Acid Extraction Kit
Sample type 10 uM FFPE tissue section (tumor cell content >20 %)
Sample capacity 48 extractions
Feature MammaTyper® IVD test kit (10 reactions)
Sample type 10 μm FFPE tissue section (tumor cell content > 20 %)
Sample capacity Up to 8 patient samples per kit
QC function 2 external controls (positive + negative)
Compatiple platforms LightCycler® 480 Instrument II (Roche)
Cobas z® 480 Analyzer (Roche)
Versant® kPCR AD module (Siemens)
Applied Biosystems® 7500 Fast (Dx) RT PCR (ThermoFisher Scientific)
CFX96TM RT PCR Detection System-IVD (BIO-RAD®)
MX3000P (Agilent®)
Agilent® AriaDx Real-Time PCR System (Agilent®
SLAN®-96P Real-Time PCR System (Sanure Biotech)

Concordance between MammaTyper® and IHC/CISH-based biomarker assessments: HER2 91.8%, ER 91.8%, PR 82.5%, KI67 75.0% 1

Overall Percentage Agreement (OPA) of assessment by MammaTyper® vs IHC/FISH (Ki67 digital image analysis): HER2 95.0%, ER 95.5%, PR 89,4%, Ki67 87,2% 4

Reproducibility Reproducibility of binary single-marker results (pos/neg), as well as the molecular subtype agreement, was almost perfect (kappa values: 0,90 – 1,00) in a 10 centre concordance study 2
Reclassification MammaTyper® may offer more precise assessment of endocrine responsiveness, improve Ki67 standardization and help resolve eqivocal HER2 IHC/FISH cases, leading to potential redistributions of the molecular subtypes 3
Catalogue Number CC01010



  1. Wirtz RM et al., Breast Cancer Res Treat 2016; 157(3), 437446
  2. Varga Z et al., Breast Cancer Res 2017; 19(55), 1-13
  3. Caselli E et al., PLOS ONE 2021; 16(9), 1-18
  4. Shaaban A et al., Eur J Cancer 2022; 175(1), 87-88
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Sysmex Europe SE

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22848 Norderstedt


+49 (40) 527 26 0

+49 (40) 527 26 100

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