Posted on Apr 03, 2023

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.

MammaTyper® is the first real innovation in subtyping breast cancer in decades. Using RT-qPCR technology proven during the COVID 19 pandemic, the multigene test works through an easily replicated and quantitative measurement of marker gene expression, classifying each sample as a St. Gallen subtype. Results are standardised and non-subjective and have high concordance with IHC. However, MammaTyper® can also accurately assess HER2-low tumours and Ki-67 markers, opening up more treatment options for patients.

Robustly reproducible, it avoids many of the common pre-analytical errors in the pathology lab, especially for proliferation marker Ki-67 - critical in luminal subtyping and prognosis. Using RT-qPCR to subtype breast cancer tissue is a valuable resource for pathologists and provides the reassurance that accurate subtyping will result in women getting the best treatment for their individual case.

Sharing deep scientific knowledge and an understanding of clinical needs, Cerca Biotech and Sysmex will work closely together to enable individualised breast cancer diagnostics across many markets.

“Repeatable, reproducible testing is the only way we can ensure that every person diagnosed with breast cancer can access the best treatment for their individual case,” said Richard Hughes, Director at Cerca Biotech. “Through this partnership with Sysmex, MammaTyper® will be available as a valuable diagnostic tool to more pathologists in more markets across Europe. We are proud that MammaTyper® will be part of Sysmex’s cutting-edge portfolio.”

“We are excited to be collaborating with Cerca Biotech and to add another cutting-edge molecular diagnostic product to our portfolio, thereby strengthening our holistic diagnostic solutions. Taking into consideration the clinical need for accurate and individualised diagnostics as well the success of our molecular products, such as OSNA” 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.”



Recent research studies undertaken in the UK, Portugal and China concluded that MammaTyper® could provide a reliable, efficient, and reproducible alternative to the molecular subtyping of breast cancer tumours. For more details on these studies, please see

MammaTyper® is part of Cerca Biotech, a German-based diagnostic company focused on bringing innovative solutions to the oncology and women’s health market. Cerca Biotech strives to introduce the best tests to meet clinical needs at an affordable cost, with clinical accuracy and rapid results at the core. For more information, please visit


Rich Hughes

Angela Parr (Communications lead)

About Sysmex Europe SE

Sysmex supports healthcare professionals around the world in lighting the way with diagnostics by providing a broad range of medical diagnostics products and solutions. In the field of life science, we have an ever-growing portfolio of solutions used throughout the pathway of cancer care in prevention, detection, diagnosis and monitoring. The mission is to support pathologists and oncologists by delivering essential genetic information, and thereby a better quality of life for patients.

Sysmex Europe SE, located near Hamburg, Germany, is a subsidiary of the Sysmex Corporation from Kobe, Japan. From our Hamburg offices, we serve our affiliates, distributors and customers throughout Europe, the Middle East, and Africa (EMEA). For more information, visit