Cerca Biotech signs distribution agreement for breast cancer diagnostic

Cerca Biotech, the company behind breast cancer diagnostic assay MammaTyper, has 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.

Using RT-qPCR technology proven during the COVID-19 pandemic, the multigene test works through a 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. MammaTyper can also assess HER2-low tumours and Ki-67 markers, opening more treatment options for patients. 

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.

Richard Hughes, director at Cerca Biotech, said: “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. 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.”

Samantha Giangregorio, head of life science, vice president Sysmex Europe SE, added: “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. 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.”