Mammatyper Presentation

MammaTyper is an innovative molecular in vitro diagnostic test (IVD) which determines the mRNA expression status of the four important breast cancer biomarkers ERBB2 (HER2), ESR1 (ER), PGR (PR) and MKI67 (marker of proliferation Ki-67) in a quantitative and reproducible way by means of RT-qPCR. This test is used for molecular subtyping of breast cancer tissue into Luminal A-like, Luminal B-like (HER2 negative), Luminal B-like (HER2 positive), HER2 positive (non-luminal) and Triple negative (ductal) tumors (according to St Gallen classification 2013).

Accurate determination of molecular subtypes is one of several key elements for defining the optimal therapy strategy. MammaTyper helps to improve subtyping by providing a reproducible, quantitative measurement of marker gene expression. This way MammaTyper helps pathologists to overcome limitations of semi-quantitative staining methods.

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Mammatyper – clinical utility

  • Reliable results – Quantitative molecular biology based method outperforms IHC by precise Ki-67 determination.
  • Supports the oncologist in selecting the appropriate therapy
  • Fast, objective, semi-automated – Generates a fast, objective and automatically assessed result using quantitative real time PCR technique
  • The determined subtype is furthermore prognostic for a patient’s risk of developing distant metastases and overall survival

Frequently asked questions:

1. What is Mammatyper?

MammaTyper® is an in vitro diagnostic test for the quantitative detection of mRNA expression of breast cancer biomarkers ERBB2, ESR1, PGR and MKI67.

2. Why it is important to characterize breast cancer tumors ?

Based on recommendations of the St Gallen Consensus group, each of the different subtypes is associated with a therapy recommendation and with a distinct prognosis of the patient.

3. What sample type can be used ?

Neutrally buffered FFPE breast cancer tissue.

4. For which population Mammatyper can be used ?

RNA isolation and MammaTyper® test can be performed within one day.
*varies from one laboratory to another.

5. How long does it take to get the results ?

RNA isolation and MammaTyper® test can be performed within one day.
*in functie de laborator

6. How much tumor material is necessary for the testing ?

Only one 10 µm FFPE tissue section is needed. Tumor cell content of the breast cancer tissue sample has to be at least 20 % as determined by a pathologist.

7. What are the main advantages of Mammatyper compared with IHC ?

  • Reliable and reproducible biomarker determination and subtyping according to St. Gallen expert panel (St. Gallen recommendation)
  • Automatically assessed and fast results obtained in one day
  • Test validated for in vitro diagnostic use
  • Prognostic information about a patient’s risk of developing distant metastases and overall survival

8. Mammatyper is present in the guidelines ?

Not yet but the guidelines recommend genetic tests as an alternative to irreproducible results obtained by IHC (for HER2 and Ki67)
Please follow the link for guidelines and literature

9. Where the test can be performed ?

Few labs were validated in Romania to perform Mammatyper:

  • Regional Institute of Oncology, Iasi
  • Bioclinica Laboratories
  • Synevo

10. How the results look like ?

Please find below a sample for a MammaTyper patient report.

Partner Labs

Contact

ORDERS Contact Info:

Email: comenzi@diamedix.ro

Mobile: +40 21/668 88 66

Address: 15A Fabrica de Glucoza Street, A4 building, zipcode 020331, Bucharest, Romania