TEST:

MammaTyper® Kit

MammaTyper®reclassifies cases considered HER2 +2 by IHC and positive by FISH, identifying 36% (7 out of 19) as HER2 positive and 42% (8 out of 19) as HER2 low. Given the critical role of accurately quantifying HER2 expression for selecting appropriate anti-HER2 treatments, this technique should be considered.

Our findings indicate a strong agreement between mRNA expression quantified by RT-qPCR and HER2 IHC scores, although there was a substantial proportion of discordant HER2 results between both methods owing to overestimation of HER2 expression by MammaTyper compared to IHC. Future large-scale trials should determine which technique is best associated with clinical outcome.

Although p53abn ECs are clinically aggressive, these tumours may present different molecular features as HER2 overexpression/amplification. Anti-HER2 target therapy represents a new therapeutic option. HER2-positive carcinomas represent a subgroup of tumours characterized by distinct histological features, although without significant prognostic impact.

Overall, MammaTyper® pCR score may serve as a standardized tool for predicting NACT response in HR+/HER2-negative BC, potentially guiding treatment strategies. Additionally, it could provide a more standardized and reproducible assessment of ER, PR, HER2, and Ki67 status.

RT-qPCR-based assessment of the mRNA expression of ESR1, PGR, ERBB2, and MKI67 showed high concordance with IHC, suggesting that the MammaTyper test on core needle biopsies represents a reliable, efficient, and reproducible alternative for breast cancer classification and refining HER2 low categorisation.

"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."

In bifocal BC, intertumoral heterogeneity on the morphological, immunohistochemical and molecular level is common, with discordant intrinsic subtype in up to 25% between individual foci, with about 8% clinically relevant discordances.

No abstracts available

"A seminal study presented at the San Antonio Breast Cancer Symposium (SABCS) this week has shown that the validated, locally performed, RNA-based MammaTyper® test provides progesterone receptor (PGR) expression determination that could predict low recurrence risk score under OncoType DX and independently identify breast tumours that are unlikely to be chemotherapy sensitive. This could obviate further testing with the multigene signature prognostic assay for up to 70% of patients."

In this selected matched pair, metastatic cohort, TROP2 mRNA in primary tumors is strongly associated with luminal type of breast cancer expressing higher levels of PGR mRNA, while no such correlation was found in matched metastatic tissues. Moreover, TROP2 is significantly downregulated in metastatic lesions. As TROP2 is expressed in luminal tumors, it may serve as a valuable target for luminal tumors of higher progression risk.

Views expressed are those of the authors and not those of the HTA Programme, NIHR, NHS or the Department of Health. Oncotype DX RS and PGR in 4 datasets Distribution of RS according to %cases with high or low PGR

No abstract available

Background: Antibody-drug conjugates such as Trastuzumab deruxtecan significantly improved progression-free and overall survival for the HER2 low expression (HER2-low) breast cancer (BC) patients, pushing the research field of HER2-low to a new climax... Compared with IHC/FISH, MammaTyper qRT-PCR assay may actually reflect the prognosis of HER2-neg/low, which is expected to become a diagnostic beacon for HER2-low target drugs.

"Sysmex Europe and Cerca Biotech said...that they have inked a deal for Sysmex to distribute Cerca's molecular breast cancer assay in 13 European markets...German diagnostic firm Cerca's RT-qPCR MammaTyper assay is used to identify breast cancer subtypes through quantitative measurement of mRNA expression status for four genes in breast cancer tissue."

Targeted sequencing with Oncomine Comprehensive Assay V3 did not reveal particular mutational patterns between the two Luminal A groups. Nevertheless, radiomic analysis of mammographic images of the cancer, as well as single cell phenotyping of the tumor microenvironment with protein multiplexing will be incorporated to further characterise elements that are phenotypically different, and potentially identify mechanistic drivers contributing to late recurrence in Luminal A cancers.

"...Shuwen Biotech...announced that it has acquired from Fudan University Shanghai Cancer Center (FUSCC) patents covering the 'Fudan Subtyping,' a breakthrough in molecular subtyping of triple-negative breast cancer (TNBC) that significantly improves treatment outcome of TNBC. Shuwen has also formed research collaboration with the Center to develop and commercialize the technology."

Background: Trastuzumab deruxtecan significantly increased progression-free and overall survival than the physician’s choice of chemotherapy for the HER2-low breast cancer (BC) patients, which opened a new chapter in the treatment of HER2-low BC...High mRNA expression of ERBB2 partially explained the response to T-DM1 in HER2 positive breast cancer, which brings up the possibility of precise detection of mRNA expression of ERBB2 to define HER2-low cohort and its guidance on drug administration... Compared with IHC/FISH, MammaTyper® qRT-PCR assay may be a promising alternative for actual detection of ERBB2 expression and define HER2-low breast cancer.

MKI67 by MammaTyper® exhibited a higher concordance with the digital Ki67 image analysis. This suggests that MammaTyper® test on needle biopsies represents a reliable, efficient and reproducible alternative for breast cancer 4- marker detection and molecular subtyping.

"Three new research studies have concluded that MammaTyper could provide a reliable, efficient, and reproducible alternative to the molecular subtyping of breast cancer tumours...Studies in the UK, Portugal and China involving over 350 samples suggest that MammaTyper, a multigene rapid PCR test to subtype breast cancer tumours could be a viable alternative to IHC testing, which is the current method used by most healthcare systems and labs around the world."

"German diagnostics firm Cerca Biotech said on Wednesday that it has signed four distribution agreements covering key European markets for its MammaTyper breast cancer subtyping assay...According to Cerca, it has struck distribution deals with Italy's AB Analytica, Turkey-based Omegen Molecular, Romania's Diamedix, and Buhlmann Labs in Switzerland to distribute the test throughout much of Southern and Central Europe."

"Cerca Biotech GmbH...announced an asset purchase agreement with BioNTech Diagnostics AG...relating to MammaTyper®, a molecular diagnostics for breast cancer subtyping. Under the agreement, Cerca will acquire from BioNTech its rights and interest in MammaTyper® and the associated nucleic acid extraction kit RNXtract®. Cerca will be responsible for the development and commercialization of the products worldwide."

Determination of the breast cancer biomarkers ER, PR, HER2 and Ki67 at the mRNA level shows high degree of correlation with IHC and compares well with correlations between original with subsequent independent manual or semi-automated IHC assessments. The use of methods with wider dynamic range and higher reproducibility such as RT-qPCR may offer more precise assessment of endocrine responsiveness, improve Ki67 standardization and help resolve HER2 cases that remain equivocal or ambiguous by IHC/FISH. In summary, our findings seem to configure RT-qPCR as a complementary method to be used in cases of either equivocal results or presenting, at the traditional determination assays, biomarkers expressions close to the cut-off values.

"High agreement rates between mRNA and IHC based intrinsic subtyping of luminal HER2 negative BC can be achieved. However, concordance between IHC and MammaTyper based luminal subtypes depends on proliferation assessment method and was highest using the mitotic activity index. Further comparative clinical studies have to address which method is to be preferred, including analysis of cost-effectiveness."

"Low cost local RT-qPCR measurements by MammaTyper® show a high agreement with the scores generated by our Oncotype DX-trained scores. The academic and well validated 95-gene signature agrees well with MammaTyper® MKI67 single gene measurement. Therefore, the locally performed MammaTyper® test may serve as cost effective surrogate for complex prognostic signatures or at least enables a pre-screening for molecularly “obviously” low risk samples."

"The MammaTyper® pCR score may serve as a standardized tool to predict response to NACT based on a pre-treatment biopsy. For patients with inoperable Luminal tumors and low predicted probability of pCR, neo-adjuvant aromatase inhibitor alone or combined with the new generation of TKIs such as CDK4/6 inhibitors or Pi3KCa/mTOR inhibitors may be an alternative for downstaging of tumors."