HER2-low – is IHC good enough anymore?

We look closer at the recent draft guidelines on HER2-testing in breast cancer, and examine alternatives to immunohistochemistry (IHC) for the task of identifying HER2-low tumours. In June 2022, one conference presentation changed how we use HER2-directed treatments in breast cancer – and challenged the status quo in HER2 testing. Is RT-qPCR the alternative to IHC for HER2 testing?


New study proves ability of MammaTyper® to accurately distinguish HER2-low breast cancer tumours

A new study conducted in China and accepted as a poster at the ASCO congress in Chicago, has shown that MammaTyper®, an RT-qPCR assay, has the ability to accurately distinguish between HER2-low/neg breast cancer tumours. This means that therapies such as Trastuzumab deruxtecan that are specifically designed to target these types of tumours can be prescribed where appropriate and treatment is more likely to be successful.


Cerca Biotech and Sysmex announce major MammaTyper® European distribution agreement

Cerca Biotech, the company behind MammaTyper®, the innovative breast cancer diagnostic assay, have signed a multi-market European distribution agreement with Sysmex Europe SE. The agreement means that MammaTyper® will form part of the Sysmex Life Sciences portfolio in 13 European markets, including the UK, Ireland and much of mainland Europe. It follows on from successful partnerships for Cerca Biotech with distributors based in Italy, Turkey and Switzerland


World Cancer Day - 4 Feb

This World Cancer Day we are proud to be featured in ITN's programme - Working Together: To Tackle Cancer. Alongside other leading organisations including Cancer Research UK, we discuss the importance of accurate diagnostics in the ever-evolving world of Cancer treatment.


What have we been up to in January?

Happy new year! We got 2023 off to a great start with our MammaTyper® International Distributor Meeting on 12th and 13th of January in Venice. Our distributors brought a wealth of clinical and technical expertise from the UK, Italy, Switzerland, Turkey, Czech Republic, Romania, Israel and Greece. Our community benefitted from pathology and oncology talks from eminent clinicians, who presented the latest updates to the MammaTyper® evidence-base. Professor Abeer Shaaban attended the day: find out more about her work in breast pathology on our blog.


Interview: Professor Abeer Shaaban: consultant breast pathologist

Professor Abeer Shaaban is a specialist consultant breast pathologist at Queen Elizabeth Hospital Birmingham and Honorary Professor at the University of Birmingham. She has led a number of research studies and contributed to landmark breast cancer trials. Dr Shaaban recently led a study with a team of researchers from the UK and Egypt comparing MammaTyper® ® RT-qPCR and immunohistochemistry (IHC) assessment on needle core biopsies of breast cancer. We spoke to Professor Shaaban about her life-saving work and her role in this piece of research.


Stage 4 breast cancer: treatment advances

Stage 4 breast cancer is also known as metastatic breast cancer, secondary breast cancer or advanced breast cancer. All these terms cover cases where the cancer has metastasized from the breast to other regions of the body. Most commonly the lymph nodes, bone, liver, lungs and brain. Signs of metastatic breast cancer depend on the site of spread


New multigene breast cancer test could speed up accurate diagnosis for women, evidence suggests

Every breast cancer tumour is unique. Accurate subtyping of breast cancer tumors is essential to determine the type of treatment that the disease is likely to respond to. This has become especially important in hard to diagnose triple negative and HER2-low cases where new immunotherapy drugs have been recently approved for use.


Treatment for triple-negative breast cancer will now be available for patients in England

The rapid diagnosis, subtyping and identification of tumours, including those that are triple-negative, is key to the fight against breast cancer.


Low HER2 breast cancer: progress in treatment needs progress in diagnostics.

Improving accurate detection of low HER-2 breast cancers.


Cerca Biotech

Cerca Biotech is the European subsidiary of Shuwen Biotech, who you might already recognise as being a highly reputable and innovative molecular and point of care diagnostics organisation.


MammaTyper® is a new tool for subtyping breast cancer.



Cerca Biotech

Cerca Biotech is the European subsidiary of Shuwen Biotech, a highly reputable and innovative molecular and point of care diagnostics organisation. Shuwen and Cerca are passionate about healthcare and are working to create world-leading innovations in the fields of Oncology and Women’s Health.


MammaTyper® - It’s time to take the stage

Innovation for your breast cancer diagnostics

High-performance test

Quantitative RT-qPCR assay (CE marked IVD)

  • Highly reproducible biomarker assessment
  • Reliable results through standardized biomarker detection
  • Accurate stratification of breast cancer tumors into St Gallen subtypes

Promising clinical utility

Clinical value validated in numerous performance evaluation studies

  • Outperforms IHC by accurate Ki-67 determination
  • Provides information on patient‘s prognosis
  • Accurate subtyping supports treatment decisions


Clinical value validated in numerous performance evaluation studies

  • Reliable method for any molecular pathology laboratory
  • Validated for multiple qPCR instruments*
  • From resection or core needle biopsy FFPE sample to result within 6 hours FFPE = formalin fixed paraffin embedded


Recent article and news

28 Sep 2023

Can immunohistochemistry reliably diagnose HER2-low?

To date, we have had little evidence of whether immunohistochemistry (IHC) can reliably diagnose HER2-low breast cancers. Now a new study has assessed the concordance between expert pathologists using IHC to assess HER2 levels – and the results will do little to reassure patients

27 Sep 2023

IHC vs MammaTyper® – how reproducible is the breast cancer diagnosis?

New developments in HER2-directed therapies have meant that people with low levels of HER2 expression may benefit from treatments such as trastuzumab deruxtecan (Enhertu). Previously this group would have been deemed ‘HER2-negative’, but now, the distinction of the HER2-low group is clinically important. In light of this, two recent studies have looked at the concordance between different laboratories on HER2-low scoring using immunohistochemistry (IHC). A study of 16 expert pathologists from the UK National Coordinating Committee for Breast Pathology found overall agreement was low. A separate European study, led by researchers at Erasmus University in the Netherlands, came to a similar conclusion.

26 Jul 2023

POETIC study reveals further insights into Ki67

Ki67 has long been recognised as a valuable prognostic marker in breast cancer, with potential as a predictive marker to guide treatment decisions. A new analysis of a landmark study has revealed more insights into Ki67 and how it relates to other clinico-pathological features. The findings serve as a reminder of the importance of Ki67, but also highlights one of the many challenges of scoring Ki67 using immunohistochemistry.