Five MammaTyper® Studies Published in EBCC-14

Studies demonstrate superior performance and clinical benefits of MammaTyper® in HER2 testing

These studies demonstrate the superior performance and clinical benefits of our MammaTyper® assay, as compared to the traditional IHC approach, especially with regard to HER2 testing.”
— Richard Hughes

BERLIN, GERMANY, March 25, 2024 /EINPresswire.com/ -- Cerca Biotech GmbH announces that in the 14th European Breast Cancer Conference (EBCC-14) in Milan, Italy from March 20 to 22, results from five different studies on MammaTyper® were presented by leading experts and researchers.

Among the studies presented, Abstract#305 (#PB-121) from Professor Emad Rakha at Nottingham University Hospital re-assessed the HER2 status with MammaTyper® in 256 IHC-defined HER2+ breast cancer cases. The patients either received anti-HER2 adjuvant therapy with chemotherapy (n=143) or only received chemotherapy (n=113). The study found that MammaTyper®-defined HER2+ patients treated with anti-HER2 therapy had significantly prolonged DFS and DMFS (HR=0.56, p=0.006 and HR=0.57, p=0.012, respectively) with less risk of recurrence compared to those who were treated with chemo only, while the IHC-defined HER2+ patients had less significant results (HR=0.62, p=0.023 and HR=0.66, P=0.04, for DFS and DMFS, respectively). Moreover, MammaTyper®-defined HER2 negative patients did not show survival difference between the group of patients who were treated with trastuzumab and those who were treated with chemotherapy only, even though all were IHC-defined HER2 positive. The authors conclude that MammaTyper® assay is more accurate than IHC in defining and identifying HER2+ BC patients that would benefit from anti-HER2 therapy. https://www.ejcancer.com/article/S0959-8049(24)00460-X/abstract

Abstract#75 (#PB-075) is a study at University of Pisa, developing decision trees and algorithms suggesting MammaTyper® could discriminate patients with HER2-positive BC who will achieve pCR from those who will not. https://www.ejcancer.com/article/S0959-8049(24)00246-6/abstract

Abstract#274 (#PB-090) is from Veneto Institute of Oncology IOV. The work indicates that MammaTyper® may provide a complementary assay to IHC/ISH to stratify hard-to-reach breast cancer groups including HER2-low, that impact subtyping and treatment plan. https://www.ejcancer.com/article/S0959-8049(24)00430-1/abstract

Abstract#278 (#PB-094) by Erasmus Medical Center indicates a strong correlation between mRNA expression quantified by MammaTyper® RT-qPCR and HER2 IHC consensus scores. Further, when comparing mRNA levels within HER2 subgroups, a significant difference in mean mRNA expression was found between HER2-0 and HER2-low (p=0.03). https://www.ejcancer.com/article/S0959-8049(24)00434-9/abstract

Abstract#279 (#PB-095) by Professor Yueping Liu of the Hebei Provincial Cancer Hospital in China is entitled “Reassessment of HER2 Status in Invasive Micropapillary Carcinoma of the Breast Recommendations for Improvement of 2023 ASCO/CAP Guideline on HER2 Testing.” They analyzed 281 consecutive patients with Invasive Micropapillary Carcinoma of the Breast (IMPC), and conclude, among others, that IMPC samples with moderate to weak Her2 IHC staining of the basolateral membrane in ≥ 10% of invasive tumor cells should be classified as 2+, and MammaTyper® may be used to determine HER2 status. https://www.ejcancer.com/article/S0959-8049(24)00435-0/abstract

“These studies demonstrate the superior performance and clinical benefits of our MammaTyper® assay, as compared to the traditional IHC approach, especially with regard to HER2 testing. They add to the existing large body of evidence supporting the use of MammaTyper® in precision testing of ER, PR, HER2, and KI-67, in breast cancer molecular subtyping, in predicting low RS score of Oncotype Dx, and in accurately identifying HER2-low from HER2-0,” said Richard Hughes, Commercial Director at Cerca Biotech.

About MammaTyper®
MammaTyper® is an innovative assay for the quantitative determination of the four key biomarkers used in the subtyping of breast cancer (Human epidermal growth factor receptor 2 (HER2), estrogen receptor (ER), progesterone receptor (PR) and Ki-67). Applying 21st Century RT-qPCR techniques, it is the first real evolution in breast cancer diagnostics for over 50 years. It is a quick, accurate, reliable, and reproducible solution that enables medical professionals to accurately tailor treatment plans for the best chance of success. MammaTyper® is the only assay of its type on the market that is backed by extensive data and research. Further information on MammaTyper® is available at https://www.cercabiotech.com/breast-cancer/mammatyper.

About Cerca Biotech GmbH
Cerca Biotech is a Germany-based diagnostic company focused on bringing novel and innovative diagnostic products to the oncology and women’s health market. We strive to introduce the best tests to meet the unmet clinical needs at an affordable cost, with clinical accuracy and rapid results to the fore. Utilising a mixture of experienced distributions and some direct sales Cerca has a commercial reach from Germany through the Nordics and Eastern Europe to the Middle East, India and beyond. Our team comprises of highly experienced commercial, technical and clinical experts in the field of IVD, allowing rapid deployment of novel technologies with a ‘get it right first time’ strategy. Cerca Biotech is an affiliated subsidiary of Shuwen Biotech. For more information, please visit: www.cercabiotech.com.

For more information:
Richard Hughes, info@cercabiotech.com

Jay Z. Zhang
Cerca Biotech GmbH and Shuwen Biotech Co. Ltd.
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