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Precise Quantitative Biomarker Detection for Molecular Breast Cancer Subtyping

BioNTech AG

Study confirms advantages of the in vitro diagnostic test kit MammaTyper® over immunohistochemistry

16 Jun 2016
Weylan Kiam-Laine
Microbiologist

Product news

BioNTech Diagnostics GmbH announces the publication of new study data that prove the significant advantages of the in vitro diagnostic test kit MammaTyper® (CE / IVD marked) over the currently established methods of detection used in breast cancer subtyping.

In the prospective-retrospective study, MammaTyper® achieved ground-breaking results with precise quantitative detection of the biomarkers ERBB2 (HER2), ESR1 (ER), PGR (PR) and MKI67 (proliferation marker Ki-67). It must be emphasized particularly that MammaTyper® was superior to immunohistochemistry with regard to the prognosis when measuring MKI67 (Ki-67). Thus the study shows that MammaTyper® ensures patient stratification as recommended by the St Gallen criteria, including reliable measurement of proliferation by MKI67. "The positive study data for MammaTyper® underline our commitment to making personalized medicine broadly available for treating cancer", added Dr Sierk Poetting, Managing Director at BioNTech Diagnostics.

Over the past few years, the IHC method has been discussed time and again by expert groups with regard to its reproducibility, objectivity and comparability. Differences do arise, particularly when measuring the proliferation marker Ki-67 which is used, for example, to differentiate between luminal A and luminal B tumors, among other things.

Previous studies have already shown that molecular detection of mRNA expression of the markers by RT-qPCR (reverse transcription quantitative real time polymerase chain reaction), on which the in vitro diagnostic test kit MammaTyper® is also based, have significant advantages over IHC.

The recently published prospective-retrospective randomized MammaTyper® clinical study enrolled a total of 769 patients from the FinHer study. It was the first to compare quantitative measurements of tumor ESR1-, PGR-, ERBB2- and MKI67-mRNA using MammaTyper® with the results of ER-, PR-, and Ki-67 protein expression by IHC or of HER2 by chromogenic in situ hybridization (CISH). The results were correlated with disease-free survival and the overall survival period. The data show that quantitative measurement of ESR1- and PGR- and ERBB2-mRNA by MammaTyper® correlates with the results from IHC and in situ hybridization in pathology laboratories [ER/ESR1: 92 %, p < 0.0001; PR/PGR: 83 %, p < 0.0001 and HER2/ERBB2: 92 %, p < 0.0001, OPA*].

Measurements of MKI67 mRNA expression with MammaTyper® showed that patients who express a low level of MKI67 have a significantly better prognosis with regard to disease-free survival and overall survival than patients with a high MKI67 expression. In contrast, measurement of Ki-67 protein expression by IHC showed no significant difference between these two groups for the prognosis of the two parameters.

The study also showed that the patients identified as luminal B by MammaTyper® who were treated with docetaxel FEC had a more favorable prognosis for disease-free survival and overall survival than those who were treated with vinorelbin FEC. The IHC results were not able to show this relation between subtype and response to the medication. This means that, compared to IHC, breast cancer subtyping by MammaTyper® opens up new opportunities of providing predictive information about the benefits of adjuvant taxane treatment.

In summary, the study clearly shows that, in comparison to established methods, MammaTyper® allows a precise biomarker measurement method that can be standardized and, due to the reliable detection of Ki-67, provides better indications of the need for and benefits of chemotherapy.

*OPA: Overall percent agreement

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ImmunologyImmunological techniques measure and characterize immune responses. Immunology kits and analysis systems often use techniques such as ELISA, radioimmunoassay (RIA) and immunodiffusion assays, Immunohistochemistry, and flow cytometry. Immunologists use equipment such as flow Cytometers, plate readers, plate washers and fluorescent microscopes.Cell-Based AssaysCell-based assays are used to monitor the presence, quantity and activities of a desired cellular analyte including drug molecules or biomarkers. This can reveal information on cell health (apoptosis, cytotoxicity, viability and proliferation assays), cell metabolism, cell migration and cell signaling mechanisms. Find the best cell-based assay products, kits and equipment with our peer reviewed product directory: compare products, check customer reviews and receiving pricing direct from manufacturers.BiomarkersBiomarkers are biological markers which can be measured and evaluated to indicate a biological state. The use of biomarkers in research and diagnosis can indicate a normal or disease state or drug response of cells / tissues. Biomarkers include genetic markers, cell surface markers such as antigens, antibodies or receptors and secreted molecules such as cytokines. An assay system is required for identification of biomarkers. :Breast CancerBreast cancer is a type of cancer that begins in the cells of the breast and can spread to other parts of the body. Early detection, accurate diagnosis, and targeted treatments are essential for improving patient outcomes. Browse our peer-reviewed product directory to find the best breast cancer research and diagnostic tools, compare products, check reviews, and get pricing directly from manufacturers.Cancer ResearchCancer research aims to understand the mechanisms of cancer development and progression to improve prevention, diagnosis, and treatment. From molecular biology to clinical trials, research spans a wide range of disciplines, including immunotherapy, targeted therapies, and drug discovery. Explore the best cancer research products in our peer-reviewed product directory; compare products, check reviews, and get pricing directly from manufacturers.Molecular DiagnosticsMolecular diagnostics use an individual’s genetic code and gene expression to diagnose and monitor diseases. The technique is used increasingly in the field of infectious diseases and oncology, as well as areas such as coagulation, HLA typing and pharmacogenomics. Molecular diagnostics plays a pivotal role in personalized medicine.ImmunohistochemistryImmunohistochemistry (IHC) is a technique used to detect specific proteins in tissue samples by using antibodies that bind to target antigens. IHC is widely applied in pathology, immunology, hematology and cancer diagnostics. Explore IHC tools in our peer-reviewed product directory; compare products, check reviews, and get pricing directly from manufacturers.In Vitro DiagnosticsIn vitro diagnostics (IVD) involve testing samples outside the body, typically in a laboratory, to diagnose diseases or conditions. IVD technologies include blood tests, molecular assays, and other bodily fluid tests, enabling accurate diagnosis and monitoring of diseases. These tests are essential for guiding treatment decisions in clinical settings. Browse our peer-reviewed product directory to find the best IVD solutions; compare products, check reviews, and get pricing directly from manufacturers.Quantitative AnalysesQuantitative analyses involve measuring the amount or concentration of a substance in a sample using analytical techniques. These analyses are essential in fields like chemistry, biology, and environmental science. Explore quantitative analysis tools in our peer-reviewed product directory; compare products, check reviews, and get pricing directly from manufacturers.Biomarker DiscoveryClinical biomarkers refer to substances related to known medical conditions that can be accurately measured <i>in vitro</i>. Biomarkers can be used to diagnose presence of a disease and indicate disease severity. The discovery of new biomarkers is incredibly valuable in the field of diagnostics.

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