Posted on Oct 19, 2022

World Evidence-Based Healthcare Day: why the research and the people behind MammaTyper® matter.

The development of robust and trustworthy medical evidence relies on global collective efforts: researchers around the world have long known this.

The pandemic has made these partnerships even more important. National and international collaboration has shown that testing, vaccines, and treatments can be brought to the public at pace: saving many lives.

This year's Evidence-Based Healthcare Day focuses on ‘partnerships for purpose.’ At Cerca Biotech, we are proponents of evidence-informed healthcare, and we are also firm believers in working with and alongside leading clinical and technical experts.

Breast cancer diagnostics backed by medical evidence

MammaTyper® improves the measurement of the key genes in breast cancer. There is a strong body of research supporting this: starting in 2016 with the first published papers on MammaTyper®, when Wirtz and colleagues proved correlation with immunohistochemistry (IHC) and chromogenic in situ hybridization (CISH) in the FinHer cohort.

There has been further published work validating the methodology for robustness and clinical accuracy. From the seminal multicentre study published by Varga and colleagues in 2017, through to the Caselli and team’s HER2 reclassification paper of 2021. We continue to answer all the questions that medical oncology asks of us.

The FinHer trial and those that have followed have shown far superior inter and intra-lab correlation, as well as the functionality to remove the ‘grey zones’ that have limited IHC, particularly in Ki-67 and HER2. Pushing its utility forwards ever since, we are looking to further use MammaTyper® results to provide information on prediction of distant recurrence and treatment-response in early-stage breast cancer.

MammaTyper® has also been used to evaluate samples from more recent clinical trials: TECHNO trial and the PREPARE trial. Pushing the use of MammaTyper® as a predictor for pCR (pathological complete response) after neoadjuvant therapy.

Clinical collaboration to enhance breast cancer care

We continue to work with specialists around the world to demonstrate that MammaTyper® has the required analytical and procedural improvements to really take breast cancer treatment forward in the 21st century.

Among the many experts who have published data with us, some key figures stand out:

  • We are working with Professor Zsuzsanne Varga, Institut für Pathologie und Molekularpathologie, University of Zurich to push the pathological utility of MammaTyper®.
  • Collaboration is ongoing with Professor Peter A. Fasching, Universitätsklinik Erlangen, Germany and Professor Dario De Biase, University of Bologna, Italy.
  • Pathology labs, such as the lab at University of Perugia under Dr. Emanuele Caselli, have been involved in clinical validation using FFPE breast cancer samples.
  • We are working closely with Queen Elizabeth hospital Birmingham and Dr Abeer Shaaban to start the first clinical utilisation of MammaTyper® in the UK.

We are continuing to forge new relationships with key centres and partners across Europe and beyond.

In the spirit of collaboration, our findings are disseminated through major peer-reviewed international publications. Including the Journal of Medical Oncology, BMC Cancer, Breast Cancer Research Treatment and Diagnostic Pathology. This year alone we have submitted three new abstracts to the EBCC in Barcelona.

Taking action to improve breast cancer diagnosis

Now is the moment to show that a simple genomic test performed in-house, using RT-PCR technology widely adopted for COVID-19 testing, can change the face and utility of breast cancer diagnosis. The ability to generate same-day quantitative results on tumour samples and match them to predetermined cut-offs for all four biomarkers can significantly change how we manage breast cancer.

The only question left is: who will come with us to start this revolution? Which government or healthcare system can look beyond the 40-year dominance of IHC and realise the answer is already here? Will global pharma carry on what BioNtech started in realising that modern pharmacology needs a modern molecular partner to companion with?

At Cerca Biotech, we have an evidence-based assay for subtyping breast cancer. What we need now is the scientific community to take up the baton of proof we have generated and change it into lifesaving, result-driven improvements in both the treatment and patient outcomes.

We’re keen to keep up the momentum of scientific progress that has been made through working collectively. When regulators, governments, scientists, researchers, clinicians, and patients work together for a common purpose, we can solve health challenges at an even faster pace.

If you’re interested in being part of this movement for change get in touch by email.