MammaTyper®

Comprehensive molecular subtyping of breast cancer patients

Precise determination of HER2, ER, PR and Ki-67 in one assay
Definitive breast cancer subtyping for confident treatment decisions
Easy-to-use, quantitative and observer-independent testing
Fast turnaround time and results within the same day
CE-marked IVD RT-qPCR assay for most commonly available cyclers

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