29 Mar 2024

Predicting recurrence with progesterone receptor testing using MammaTyper®

One of our four key goals for clinical validation in 2024 is to demonstrate that progesterone receptor (PR) testing with MammaTyper® could be used for predicting risk of recurrence. In this article, we assess the current role of PR, where IHC testing falls short, and how MammaTyper® could provide a reliable, more accessible option for risk scoring.

PR – the forgotten marker?

In breast cancer testing, progesterone receptor (PR) is sometimes considered the ‘forgotten marker’. Unlike ER or HER2, there are no treatments in current clinical practice linked to the presence or absence of PR. As a res...

26 Feb 2024

Defining HER2-low using MammaTyper®

One of our four key goals for clinical validation in 2024 is to demonstrate that MammaTyper® is a more reliable way to define HER2-low status. In this article, we assess the importance of HER2-low, where IHC testing falls short, and how MammaTyper® could improve diagnosis and treatment for this group of patients.

21 Dec 2023

Cerca Biotech’s 2023 Highlights

2023 was a stand out year for Cerca Biotech. We doubled our team, added a major partner in Sysmex Europe, and were present at all the major congresses. At the same time, the pharmaceutical world took some big steps forward with defining trials in ADC and CDK 4/6 therapy, both of which have an inherent need for more reliable and reproducible testing for HER2 and Ki67 - which MammaTyper® can provide.

We look back on the work we have done this year around branding and marketing with pride. Our small but massively experienced team has pulled together to put MammaTyper® on the map in a way we could...

08 Dec 2023

Interview: Ralph Wirtz, on progesterone receptor testing

A seminal study presented at the San Antonio Breast Cancer Symposium (SABCS) 2023 has shown that progesterone receptor (PGR) gene expression testing with MammaTyper® could independently identify tumours that are unlikely to be chemotherapy sensitive. This could screen out further genomic testing for up to 70% of patients. Dr Ralph Wirtz, CEO of STRATIFYER and co-developer of MammaTyper® with Prof Ugur Sahin from BioNTech, is one of the authors of the SABCS study. We spoke to Ralph to get his insight on the key takeaways from the study, and what they mean for pathologists and oncologists.

08 Dec 2023

SABCS 2023: Study shows that locally-performed RNA-based PGR test could effectively predict breast cancer tumour expression

A seminal study presented at the San Antonio Breast Cancer Symposium (SABCS) this week has shown that a validated, locally performed, RNA-based progesterone receptor (PGR) expression test could predict tumour gene expression results and independently identify tumours that are unlikely to be chemotherapy sensitive. This could screen out further genomic testing for up to 70% of patients.

07 Nov 2023

Interview: Prof Sunil Badve on Ki67 testing

Interview: Prof Sunil Badve on Ki67 testing Professor Sunil Badve, MD, FRCPath, is Vice Chair for Pathology Cancer Programs and Professor at Emory University in Atlanta, Georgia, USA. He is a surgical pathologist and translational researcher with expertise in breast cancer and thymic pathology. He was also a member of the International Ki67 in Breast Cancer Working Group. We spoke to Sunil about the role of Ki67 in modern breast cancer diagnosis and treatment, as well as the challenges of testing with immunohistochemistry (IHC), and the opportunities and challenges for RT-PCR testing of Ki67.

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.

25 Jun 2023

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.

10 Jun 2023

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.

03 Apr 2023

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.

27 Jan 2023

What have we been up to in January?

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.

19 Jan 2023

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.

06 Dec 2022

Stage 4 breast cancer: treatment advances

Breast cancer tissue is assessed at diagnosis to determine treatment approach and prognosis. Whilst stage 4 or metastatic breast cancer is classed as incurable, treatment options that can prolong life are becoming available. However, we need to ensure that diagnostic technology used in labs keeps pace with advances in treatment, so that those with this late-stage cancer can access these innovative therapies

25 Nov 2022

MEDICA and EBCC: Rich’s Conference Diary

Cerca Biotech was well represented last week at both MEDICA 2022 and the EBCC13 meeting in Barcelona. Interest in MammaTyper® at MEDICA; the interest was for both our MammaTyper® RT-PCR breast cancer subtyping assay and the newly released CercaTest Pre-eclampsia Vue™ point of care test. Breast cancer innovation showcased at EBCC The 13th European Breast Cancer Conference (EBCC) in Barcelona saw clinicians involved in breast cancer care from across Europe and beyond descend on Barcelona for a three-day meeting.

22 Nov 2022

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

Three new research studies have concluded that MammaTyper could provide a reliable, efficient, and reproducible alternative to the molecular subtyping of breast cancer tumours.

16 Nov 2022

Research Project N.1 from Univ. Birmingham (UK)

Breast cancer biomarkers help clinicians determine a patient’s breast cancer sub-type. This plays a vital role in tailoring treatment effectively. Newer multigene tests such as MammaTyper® go further in assessing intrinsic properties of breast cancer tumours that impact on tumour behaviour.

16 Nov 2022

Research Project N.2 from Portugal

Traditionally, breast cancer prognosis is determined using immunohistochemistry (IHC). With the development of genomics (the study of the genes in our DNA), molecular subtyping became available, enabling clinicians to better decide on the best treatment approach for patients.

16 Nov 2022

Research Project N. 3 from Zhejiang University School of Medicine (China)

Traditional immunohistochemistry (IHC) methods may not offer precise differentiation between HER2-negative and HER2-low tumours. This could be due to human differences in interpretation for example. Some patients who may benefit from this new life-extending treatment may not be picked up using IHC and therefore will not have access to it