Menu

MammaTyper®

MammaTyper® precisely quantifies expression of HER2, ER, PR and Ki-67 mRNA

MammaTyper® is a molecular diagnostic test for quantitative determination of the four key biomarkers used in the subtyping of breast cancer.

Human epidermal growth factor receptor 2 (HER2), estrogen receptor (ER), progesterone receptor (PR) and the marker of proliferation Ki-67 are key biomarkers in the evaluation of breast cancer tumours.

The combination of biomarker results allows the assessment of the different St. Gallen Breast Cancer subtypes which are key parameters for treatment decisions.

Definition of Breast Cancer Surrogate Subtypes
(St Gallen 2013)

Breast Cancer Subtypes ER PR HER2 Ki-67
Luminal A-like Pos Pos Neg Neg
Luminal B-like (HER2 negative) Pos Pos/Neg* Neg Pos/Neg*
Luminal B-like (HER2 positive) Pos Pos/Neg Pos Pos/Neg
HER2 positive (non-luminal) Neg Neg Pos Pos/Neg
Triple negative (ductal) Neg Neg Neg Pos/Neg

*with the exception of the combination PR pos and Ki-67 neg = Luminal A-like

MammaTyper® is designed to meet the need for standardized, quantitative and fast molecular subtyping enabling confident treatment decisions.

Features

MammaTyper® is an easy-to-use test for any pathology laboratory, delivering precise results within 6 hours.

 

1

Sample preparation

10 μm FFPE tissue section (tumor cell content > 20 %).  

2

RNA extraction

Use of RNA FFPE sample extraction kit according to IFU or validated commercial RNA extraction systems is recommended.
3

MammaTyper® test set up

Preparation of mastermixes and distribution on 96 well plate. Analysis of up to 8 patient samples per run.

4

RT-qPCR analysis

Validated on the following qPCR instruments:

  • 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)
5

Data processing and reporting

Convenient MammaTyper® Report Generator software:

  • Export of mRNA expression data.
  • Calculation and assessment of results.

MammaTyper® is a trademark in various jurisdictions, which is exclusively licensed to Cerca Biotech www.cercabiotech.com

Technical Specifications
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

 

References

  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
Contact
You have a question and would like to get in touch with our experts? We look forward to receiving your enquiry.

Sysmex UK LTD

Sysmex House

Garamonde Drive

Wymbush

Milton Keynes

MK8 8DF

0333 320 3460

Documents

Product documents

Regulatory Documents

Regulatory documents, such as Instructions for Use, can be accessed with a valid My Sysmex login:

Go to My Sysmex

Explore more

Copyright © Sysmex Europe SE. All rights reserved.