Real-Time Quick-Response PCR Test Marks First Real Innovation in Subtyping Breast Cancer in Decades

By LabMedica International staff writers
Posted on 04 Apr 2023

Image: The MammaTyper test is optimized for use in every molecular pathology laboratory (Photo courtesy of Cerca)

Breast cancer is the most prevalent cancer among women, with one in seven expected to be diagnosed during their lifetime. The 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 for their recovery. Accurately subtyping the tumor is a critical aspect of treatment, but the process has remained largely unchanged for over 50 years and is susceptible to inaccuracies. Now, a new real-time quick-response PCR (RT-qPCR) test is set to usher in the first real innovation in subtyping breast cancer in decades.

Cerca Biotech’s (Berlin, Germany) MammaTyper RT-qPCR test represents a modern approach to subtyping breast cancer, providing reliable, accurate, and prompt results for every tissue sample. This technology offers a strong basis for treatment planning, providing every woman with the best possible chance of overcoming breast cancer. By employing RT-qPCR technology validated during the COVID-19 pandemic, this multigene test works through an easily replicated and quantitative measurement of marker gene expression, classifying each sample as a St. Gallen subtype. The results are objective and standardized, displaying high consistency with IHC. Furthermore, MammaTyper can precisely evaluate HER2-low tumors and Ki-67 markers, broadening the range of treatment options available to patients.

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

One of the crucial components in selecting the best therapy for breast cancer patients is accurately determining their molecular subtypes. MammaTyper enhances subtyping by providing an easily replicated and quantitative measurement of marker gene expression. This approach overcomes the drawbacks of semi-quantitative staining methods and enables pathologists to improve subtyping precision. The MammaTyper test is suitable for use as a primary diagnostic test (biopsy) for all breast cancer cases. It is also applicable for analyzing resection specimens and metastases, and can serve as a secondary assessment in cases with ambiguous IHC results, or as a rapid test for ERBB2 (HER2) determination. Additionally, it can be utilized as a substitute for IHC and in situ hybridization (FISH/CISH).

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