Complementary CE IVD-marked product for the MammaTyper kit
Faster procedure eliminates the need for a column system in nucleic acid purification by utilizing magnetic beads.
Environmentally friendly and safer for users as it does not utilize a deparaffinization reagent and reduces plastic material waste.
Fast turn-around-time, procedure is quicker and requires less steps

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	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