TEST:

APIS Breast Cancer Subtyping Kit

No abstract available

No abstract available

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."