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New RT-qPCR Test Offers Rapid and Accurate Breast Cancer Subtyping: The MammaTyper Test from Cerca Biotech

Image: The Mamma Typerr test is optimized for use in all molecular pathology laboratories (Photo courtesy of Cerca)

Breast cancer is the most frequent cancer among women, it is expected that one in seven will be diagnosed during her lifetime. Early detection and treatment of the disease have greatly improved survival rates. However, for women with invasive breast cancer, receiving the best possible treatment quickly is crucial to their recovery. Accurate tumor subtyping is an important aspect of treatment, but the process has remained largely unchanged for more than 50 years and is susceptible to inaccuracies. Now, a new real-time rapid response PCR (RT-qPCR) test will usher in the first real innovation in breast cancer subtyping in decades.

The RT-qPCR MammaTyper test from Cerca Biotech (Berlin, Germany) represents a modern method for subtyping breast cancer, providing reliable, accurate and rapid results for each tissue sample. This technology offers a solid foundation for treatment planning, giving each woman the best possible chance of overcoming breast cancer. Employing RT-qPCR technology, validated during the COVID-19 pandemic, this multigene test works through a quantitative and easy-to-replicate measurement of marker gene expression, classifying each sample as a St. Gallen subtype. The results are objective and standardized, showing high consistency with IHC. In addition, MammaTyper can accurately assess tumors with low HER2 and Ki-67 markers, thus expanding the range of treatment options available to patients.

The MammaTyper kit uses RNA extracted from standard formalin-fixed paraffin-embedded (FFPE) sample material commonly used in clinical routine, and offers a streamlined molecular pathology workflow to provide reliable same-day results, including assay results. ERBB2 (HER2). This method is highly reproducible and reduces common preanalytical errors, especially for the proliferation marker Ki-67, which is critical in luminal prognosis and subtyping. The use of RT-qPCR technology for subtyping of breast cancer tissue provides valuable assistance to pathologists and ensures that accurate subtyping leads to personalized and effective treatment plans for women with breast cancer.

One of the most important components in selecting the best therapy for breast cancer patients is to accurately determine their molecular subtypes. MammaTyper improves subtyping by providing a quantitative and easy-to-replicate measurement of marker gene expression. This approach overcomes the drawbacks of semi-quantitative staining methods and allows pathologists to improve subtyping accuracy. The MammaTyper test is suitable for use as a primary diagnostic (biopsy) test for all cases of breast cancer. It is also applicable for testing resection specimens and metastases, and can serve as a secondary evaluation in cases with equivocal IHC results, or as a rapid test for ERBB2 (HER2) determination. Furthermore, it can be used as a substitute for IHC and in situ hybridization (FISH/CISH).

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Cerca Biotech

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