Posted on Dec 21, 2023

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 not have imagined last year.

For us, 2024 will be the year of clinical utility. We have already proven that MammaTyper® corresponds well to good quality IHC. We now need to show that it can actively improve the selection of treatments for patients in a way that the qualitative IHC method will never attain. For true diagnostic-led treatment and companion diagnostics, accurate quantitation is the only way ahead.

Rich Hughes, Director, Cerca Biotech

**Here’s just a handful of the big achievements for Cerca Biotech and MammaTyper® in 2023, and what we have to look forward to in 2024:

Distribution deal with Sysmex

In April 2023, Cerca Biotech signed a multi-market European distribution agreement with Sysmex Europe SE. The agreement meant that MammaTyper® will form part of the Sysmex Life Sciences portfolio in 13 European markets, including the UK, Ireland and much of mainland Europe. As a result we now have distribution agreements in more than 20 countries around the world.

“We are excited to be collaborating with Cerca Biotech and to add another cutting-edge molecular diagnostic product to our portfolio,” said Samantha Giangregorio, Head of Life Science, Vice President Sysmex Europe SE. “MammaTyper® has the potential to play a key role in the breast cancer diagnostic pathway, providing guidance for the right treatment, thus improving the quality of life of patients.”

MammaTyper® can accurately distinguish HER2-low breast cancers

A study presented at ASCO in June 2023 showed that MammaTyper® can distinguish between HER2-low and HER2-negative breast cancers. The study of 793 cases showed that, when distinguished by MammaTyper®, the long-term prognosis of ‘HER2-low’ patients was significantly better than ‘HER2-negative’ patients. The same distinction could not be made when using immunohistochemistry.

Rich Hughes, Director at Cerca Biotech, commented “For HER2-low/neg tumours, it is clear that IHC just isn’t accurate enough anymore and new diagnostic tools are needed. MammaTyper® can give pathologists the confidence to subtype breast cancer tissue accurately and quickly and provide a clear picture to clinicians and patients.”

We believe RT-qPCR may provide a complementary assay to IHC/ISH to stratify hard-to-define breast cancer groups, including HER2-low, to improve subtyping and treatment planning.

Progesterone receptor testing could identify tumours unlikely to need chemotherapy

A seminal study presented at San Antonio Breast Cancer Symposium (SABCS) in December 2023 showed that testing for progesterone receptor (PgR) with MammaTyper® could predict tumours which are unlikely to require chemotherapy. Strong PgR expression – present in up to 70% of cases – predicts favourable outcomes for ER+ve HER2-ve breast cancer, and could avoid the need for further costly genomic testing with Oncotype DX. Dr Ralph Wirtz, one of the authors of the study, and co‑developer of MammaTyper®, gave us his [thoughts on what the results mean for clinicians] (

Completed and ongoing studies

In 2023, British researchers completed two further studies of MammaTyper®: one in Birmingham and another in Nottingham. Ongoing studies of MammaTyper® continue across Europe, with trials taking place in the Netherlands, Spain, Italy, Poland, Greece, Germany, and Switzerland.

Conversations around the world

In 2023, the Cerca Biotech team has been busy attending and presenting at conferences across the world. For example, we had a stand at ESMO Breast Cancer congress in Berlin in May, and a joint stand with Sysmex Europe at ESMO congress in October. As a result, we’ve been able to have conversations with more than 100 clinicians around the world about MammaTyper® and how it could help them.

2024 is already shaping up to be another busy year, with seven abstracts related to MammaTyper® submitted to the first big show of the year: EBCC in Milan.

In 2024, we’re looking to partner with clinicians to conduct trials of MammaTyper® to answer some of the remaining questions about the test. If you want to be a part of this, please get in touch: