PCR style breast cancer test launched in bid to improve diagnosis – Med-Tech Innovation
A recently acquired assay designed to improve the diagnosis of breast cancer tumours has been launched in the UK and Europe.
MammaTyper applies 21st Century RT-qPCR technology to quantify mRNA levels of the four essential breast cancer biomarkers (ER, PgR, HER2 (ERBB2), and Ki-67). It is quicker, non-subjective and significantly less expensive than current methods and other molecular assays.
Robustly reproducible, MammaTyper avoids many of the common pre-analytical errors and wide variety of methods used in the pathology lab, especially for proliferation marker Ki-67 – critical in luminal subtyping and prognosis. Using RT-qPCR to enable the subtyping of breast cancer tissue is a valuable resource for pathologists and provides the reassurance that accurate assessment of proliferation and other markers will result in women getting the best possible treatment for their individual case.
MammaTyper results are ready within hours. The kit has been validated on six different real-time PCR instruments, which are now more readily available given their use in the COVID-19 pandemic. Testing can therefore be done locally, and each sample can then be classified as a St Gallen subtype. Results provide oncologists and clinical teams with a reliable, objective, and accurate foundation from which to build the best treatment plan for a patient, hopefully giving the best chance of success.
Richard Hughes, commercial director at MammaTyper, said: “We are genuinely excited to be able to bring MammaTyper to the UK and European markets. It has the potential to make a real difference to clinical outcomes for women who have been diagnosed with invasive breast cancer. By offering an alternative to traditional subtyping methodology, we believe that patients will be able to quickly start on the right treatment path for them and therefore have the best chance of fighting the disease. Current and novel pharmacological treatment regimens demand accurate initial assessment of the tumour, which is exactly what MammaTyper provides.”
Professor John Bartlett, a pathologist, said: “With particular reference to the assessment of proliferation markers such as Ki67, there has been a long-term focus on technically suboptimal approaches such as IHC. Given the explosive growth in technology, and in particular the evidence to support molecular approaches to assessment of biomarkers as more reproducible and more quantitative than existing methods, the use of assays such as MammaTyper are a logical solution. This assay could, immediately, improve the reproducibility and accuracy of assessment of markers over that provided by technologies developed in the 1970s.”