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Novel Diagnostic Test Validated as Predictor for Response After Neoadjuvant Chemotherapy (NACT) in Patients with Early Breast Cancer

BioNTech AG

New results suggest the MammaTyper test could predict the likelihood of complete pathologic remission

3 Dec 2018
Frankie MacDonald
Administrator / Office Personnel

Product news

BioNTech Diagnostics GmbH have announced new results from a clinical performance evaluation study of the CE-marked IVD MammaTyper® which were presented at the European Society for Medical Oncology (ESMO) in Munich in October.

For this prospectively planned study, samples from the TECHNO and PREPARE trial cohorts were used to validate a pre-defined score and cut-off integrating highly standardized mRNA measurements of ERBB2 (HER2), ESR1 (ER), PGR (PR) and MKI67 (Ki-67) by MammaTyper. The score allows the prediction of pathological complete response (pCR) after neoadjuvant chemotherapy (NACT) based on the pre-treatment biopsy. The cut-off accurately separates patients with a good response rate from patients with a low probability of pCR for which a different treatment than NACT or additional post-neoadjuvant treatment may be considered.

Additionally, it was demonstrated that standardized measurement of ERBB2, ESR1, PGR and MKI67 mRNA is comparable to the determination of the markers on IHC level and is strongly associated with response to NACT as well as long-term outcome.

Within the group of HER2-positive patients from the TECHNO trial ERBB2 mRNA predicted pCR in the subgroup of ESR1 positive samples and may carry additional information that may help to better predict response based on the pre-treatment biopsy.

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“Achieving a pCR after NACT in breast cancer (BC) is strongly associated with long-term disease-free survival. Although the prognostic impact of pCR on different BC subtypes may vary, achieving pCR remains an important factor in clinical decision-making”, said Prof. Dr. med. Sibylle Loibl, CEO of GBG Forschungs GmbH and chair of the German Breast Group.

“Reliable procedures for predicting pCR before treatment are limited as current predictors of pCR like imaging, clinical and histopathological parameters may need improvement before implementation in clinical routine”.

These studies demonstrated that the MammaTyper test, with its accurate and reproducible assessments of ERBB2, ESR1, PGR and MKI67 mRNA levels from pre-treatment biopsy, could be used as a valid predictor of the likelihood of complete pathologic remission after neoadjuvant chemotherapy treatment. A standardized predictive model has been used successfully in combination with other clinic-pathological factors facilitating the identification of patients who most likely will not respond to neo-adjuvant chemotherapy and therefore helps clinicians in deciding on the therapeutic approach.

About MammaTyper
MammaTyper is a molecular in vitro diagnostic test for quantitative detection of the mRNA expression status of the genes ERBB2 (HER2), ESR1 (ER), PGR (PR) and of MKI67(proliferation marker Ki-67) in the tumour tissue of female patients with newly diagnosed invasive breast cancer. The test has been validated for total RNA extracted from tissue specimens or biopsies.

MammaTyper is used for molecular subtyping of breast cancer tissue according to the St Gallen classification (2013) in luminal A-like, luminal B-like (HER2 negative), luminal B-like (HER2 positive), HER2 positive (non-luminal) and triple negative (ductal) tumours, and offers together with further clinical pathological factors the possibility of significantly improving the diagnostic and the treatment of female patients with breast cancer.

The test can be carried out in any pathology laboratory. MammaTyper can be used on all female patients with newly diagnosed invasive breast cancer and provides the results on the same day.

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Cellular PathologyCellular Pathology deals with the microscopic analysis of tissue samples and cells. Sample preparation and processing includes fixation, staining, sectioning and slide mounting, using equipment such microtomes and cryostats. In choosing immunohistochemistry and immunocytochemistry kits, consider chromogens, staining method, antibodies, microscopes and imaging.DNA / RNA Extraction and PurificationPurified DNA and RNA are required for numerous downstream molecular biology applications. Consequently, the importance of high-quality DNA/RNA extraction and purification equipment cannot be underestimated. Many purification kits are available and are typically optimized for nucleic acid type and source, including plasmid DNA, genomic DNA, mRNA, RNA and viral nucleic acid purification kits. Automated extraction and purification of nucleic acids can be implemented with magnetic bead separator instruments or high-throughput purification workstations. Find the best DNA/RNA extraction and purification equipment in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Point-of-CarePoint-of-Care Testing (POCT) or Near Patient Testing (NPT) products are available for urine, blood and other clinical chemistry analyses. POCT includes: blood glucose testing, blood gas and electrolytes analysis, rapid coagulation testing (PT / INR), rapid cardiac markers diagnostics, drugs of abuse screening, urine strips testing, pregnancy testing, fecal occult blood analysis, food pathogens screening, hemoglobin diagnostics, infectious disease testing and cholesterol screening.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. :Clinical GeneticsMolecular Genetics covers the analysis of hereditary genetic disease and chromosomal abnormalities. Genetics can be analysed using DNA, RNA, and protein microarrays, PCR, RT PCR and DNA sequencing. Genetic equipment includes genetic workstations, thermal cyclers, cooling blocks and electrophoresis products. Diagnostic kits are used for DNA / RNA extraction and purification.Clinical TrialsClinical Trials, an essential part of drug discovery process, assess the safety and effectiveness of a new medication or device in the pharmaceutical industry. Clinical Trials are a phased process (Phase 0, Phase I, Phase II, Phase III and Phase IV) which begins after initial preclinical testing.Cancer DiagnosticsThere are a wide variety of diagnostic tests for cancer available, and this range continues to expand as our knowledge of cancer improves. Current diagnostic methods include biopsy, imaging and blood tests for known biomarkers. New methods in research development include liquid biopsies and cancer breathalyzers.RNARNA is a nucleic acid that plays a key role in gene expression and protein synthesis. It serves as a messenger between DNA and ribosomes, carrying genetic instructions to produce proteins. Advances in RNA-based therapies, such as mRNA vaccines and gene editing, have revolutionized treatment strategies for genetic disorders and infectious diseases. Explore RNA research tools and therapies in our peer-reviewed product directory; compare products, check customer 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.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.

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Novel Diagnostic Test Validated as Predictor for Response After Neoadjuvant Chemotherapy (NACT) in Patients with Early Breast Cancer