TEST:

APIS Breast Cancer Subtyping Kit

The APIS kit accurately measures HER2/ERBB2 expression. The findings indicate that relying solely on IHC stratification may not be sufficient to predict responses to novel anti-HER2 treatments, like T-Dxd. By leveraging the dynamic range of RNA expression, a ΔCt semi-quantitative scale using additional cut-offs has been developed to enhance the stratification of ERBB2 mRNA expression.

By leveraging the dynamic range of RNA expression, this study established a ΔCt semi-quantitative scale for evaluating targets with the APIS Breast Cancer Subtyping Kit. This is particularly significant for the classification of HER-low, which has emerged to be critical in identifying patients who may benefit from novel anti-HER2 therapies.

A high level of agreement between IHC/ISH and mRNA expression determined by the APIS kit was observed for all markers. Subtype call agreement improved when Ki67 status was excluded, likely due to the challenges in distinguishing high and low Ki67 expression with IHC, leading to ambiguity in differentiating luminal B HER2- from luminal A tumours. Molecular subtyping offers additional insights for guiding breast cancer management decisions.

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"PT Global Bioray Teknologi and APIS Assay Technologies Sign Collaboration to Commercialise the ESR1 Mutations Kit & the Breast Cancer Subtyping Kit..."

The APIS Breast Cancer Subtyping Kit accurately detects HER2/ERBB2 expression. The findings suggest that relying solely on IHC categorisation may not suffice for predicting response to novel anti-HER2 treatments. Utilising additional cut-offs could enhance the stratification of ERBB2 mRNA expression, distinguishing a ‘HER2- low’ group.

We have utilised the dynamic range of RNA expression to provide a ΔCt semi-quantitative scale for assessing targets with the APIS Breast Cancer Subtyping Kit in comparison to IHC % staining and immunoreactivity. This being particularly significant for HER2 low classification, emerging as a crucial marker to identify patients who could benefit from novel anti-HER2 therapies. Similarly, ER-low tumours are now being explored as a clinically and biologically unique subgroup.

All kits yielded suitable RNA for APIS Breast Cancer Subtyping Kit. High target agreement was observed in specimens extracted using Promega and BioEcho kits, making them viable alternatives to QIAGEN. Thermo Fisher’s kit could also be considered for use, accounting for possible tumour heterogeneity.

This study has established a methodology that utilises target copy number values and IHC protein quantification to establish ΔCt cut-off points. For each target we have defined four distinct groups as negative, low, medium, and high expression. This approach provides a semi-quantitative scale for evaluating each target with the APIS BCSK and serves as a valuable tool for classifying and understanding target expression levels.

APIS BCSK accurately detects HER2 expression. The results confirm that IHC stratification may not be an adequate method for predicting the response to novel anti-HER2 therapies, such as T-DXd. Implementation of additional cut offs could allow further stratification of ERBB2 mRNA expression, however, additional studies correlating the expression level to anti-HER2 treatment response are required to validate this approach.

Table: 37P Summary of individual target bin,ΔCt range and category Target Lower ΔCt limit Upper ΔCt limit Expression classification ESR1 - 1.215 - High PGR - 2.867 - High ERBB2 - 2.054 - High MKI67 - 0.417 - High Conclusions This study has established a methodology that utilises target copy number values and IHC quantification to establish ΔCt cut-off points. With this approach, we have defined four distinct classifications, providing a semi-quantitative scale for evaluating targets with the APIS BCSK.

Results confirm that IHC stratification may not be an adequate method for predicting the response to novel anti-HER2 therapies, such as T-DXd. Implementation of additional cut offs could allow further stratification of ERBB2 mRNA expression, however, additional studies are required to validate this approach.

In conclusion, our study indicates that the APIS Breast Cancer Subtyping Kit is highly concordant when compared to the results produced for ER/PR/HER-2 by IHC and/or ISH. The assay could play a role in the routine assessment of newly diagnosed breast cancer (BC) specimens.

High level of agreement between IHC/ISH and APIS Breast Cancer Subtyping Kit mRNA expression was observed for all markers, successfully demonstrating APIS Breast Cancer Subtyping Kit's strong clinical accuracy. The overlap observed in ERBB2 confirms that IHC stratification may not be an adequate method for predicting the response to novel anti-HER2 therapies and suggests that incorporating continuous quantification of HER2 could optimize patient outcomes.

"The article is titled ‘Comprehensive and Accurate Molecular Profiling of Breast Cancer through mRNA Expression of ESR1, PGR, ERBB2, MKI67, and a Novel Proliferation Signature‘ published in MDPI."

The APIS Breast Cancer Subtyping Kit exhibits improved agreement with the PAM50 molecular subtype in contrast to the IHC-derived subtype, indicating that molecular testing may be a more suitable method for determining proliferation and distinguishing between luminal A and B subtypes. Furthermore, there is a significant correlation between the RS generated by APIS Breast Cancer Subtyping Kit proliferation signature and both PAM50 and Oncotype RS. These initial findings indicate that the APIS Breast Cancer Subtyping Kit proliferation signature has the potential to accurately identify patients at risk of recurrence, although additional studies including a larger proportion of events are needed to validate these results.

Trastuzumab deruxtecan (T-Dxd), an antibody-drug conjugate targeted at HER2, has recently gained approval in the USA and Europe for treating HER2-low BC, which is currently defined as immunohistochemical (IHC) scores of 1+ or 2+ without HER2/ERBB2 in situ hybridization (ISH) amplification... APIS Breast Cancer Subtyping Kit can accurately detect HER2 expression and has the potential to further stratify the HER2-low patients. Further studies examining the relationship between HER2 expression and the response to anti-HER2 therapies could yield valuable insights into treatment administration and identify patients who could benefit from such therapies. Incorporating continuous quantification of HER2 could optimize patient outcomes.

APIS Breast Cancer Subtyping Kit demonstrated a high level of concordance with standard of care IHC/FISH in assessing breast cancer biomarker status. These findings suggest that the APIS Breast Cancer Subtyping Kit provides highly precise and reproducible quantitative assessment of BC biomarkers and molecular subtypes. Inclusion and exclusion criteria

Trastuzumab deruxtecan (TDxd), an antibody-drug conjugate targeted at HER2, has recently gained approval in the USA and Europe for treating HER2-low BC, which is currently defined as immunohistochemical (IHC) scores of 1+ or 2+ without HER2 in situ hybridization (ISH) amplification... APIS Breast Cancer Subtyping Kit can accurately detect HER2 expression and has the potential to further stratify the HER2-low patients. Further studies examining the relationship between HER2 expression and the response to anti-HER2 therapies could yield valuable insights into treatment administration and identify patients who could benefit from such therapies. Incorporating continuous quantification of HER2 could optimize patient outcomes.

The APIS BCS shows improved agreement with the PAM50 molecular subtype, indicating that molecular testing may be a more suitable method for determining proliferation and distinguishing between luminal A and B subtypes. There is a significant correlation between the APIS BCS proliferation signature and both PAM50 and Oncotype RS, indicating that APIS BCS has the potential to accurately identify patients at risk of recurrence, although additional studies with higher event proportion are needed to validate these results.

APIS Breast Cancer Subtyping Kit demonstrated a high level of concordance with standard of care methods (IHC/FISH) in assessing BC biomarker status. These findings suggest that the APIS Breast Cancer Subtyping Kit provides highly precise and reproducible quantitative assessment of biomarkers and molecular subtypes.

"Biocartis Group NV...announces the launch of the new Breast Cancer Portfolio during the Breast Cancer Awareness month: the Idylla™ PIK3CA-AKT1 Mutation Assay and, in collaboration with APIS Assay Technologies (APIS), the APIS Breast Cancer Subtyping Kit and the APIS ESR1 Mutations Kit."

"Biocartis Group NV...and APIS Assay Technologies Ltd...announce that they have entered into a new partnership agreement which targets the development of APIS’ Breast Cancer Subtyping assay on Biocartis’ rapid and easy-to-use molecular diagnostics platform Idylla™....Under the terms of the partnership agreement, APIS will lead the development of the Breast Cancer Subtyping test on Idylla™, while Biocartis will lead the commercialisation through its growing Idylla™ network."