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Breast Cancer Molecular Subtyping in Practice: A Real-World Study of the APIS Breast Cancer Subtyping Assay in a Consecutive Series of Breast Core Biopsies

  • 0Department of Cellular Pathology, Berkshire & Surrey Pathology Services, The Royal Surrey Hospital NHS Foundation Trust, University of Surrey, Egerton Road, Guildford GU2 7XX, UK.
International Journal of Molecular Sciences +

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March 13, 2024

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March 13, 2024

View abstract on PubMed

Summary

This summary is machine-generated.

The APIS Breast Cancer Subtyping Kit accurately assesses breast cancer (BC) subtypes using mRNA. It shows high concordance with standard methods for estrogen receptor (ER), progesterone receptor (PR), and HER-2, supporting its role in routine BC diagnosis.

Area Of Science

  • Oncology
  • Molecular Diagnostics
  • Biomarker Analysis

Background

  • Accurate breast cancer (BC) subtyping is crucial for treatment decisions.
  • Current standard methods include immunohistochemistry (IHC) and in situ hybridisation (ISH) for key biomarkers.
  • There is a need for novel molecular assays to complement existing diagnostic protocols.

Purpose Of The Study

  • To evaluate the concordance of the APIS Breast Cancer Subtyping Kit with standard IHC/ISH methods.
  • To assess the kit's performance in determining molecular subtypes for newly diagnosed breast cancer.
  • To investigate the utility of a novel four-gene proliferation signature within the kit.

Main Methods

  • The APIS kit, an mRNA-based assay, assessed seven parameters including ER, PR, HER-2, and a four-gene proliferation signature (MKI67, PCNA, CCNA2, KIF23).
  • Results were compared against IHC and/or ISH in 100 pre-operative breast cancer core biopsies.
  • Concordance rates for individual biomarkers and the proliferation signature were calculated.

Main Results

  • High concordance was observed between the APIS kit and IHC/ISH for ER (97%), PR (89%), and HER-2 (100%).
  • The four-gene proliferation signature showed a 24% discordance with Ki-67 IHC alone, indicating a distinct molecular profile.
  • The APIS assay successfully generated molecular subtypes for all assessed samples.

Conclusions

  • The APIS Breast Cancer Subtyping Kit demonstrates high concordance with established IHC/ISH methods for ER, PR, and HER-2 assessment.
  • The kit provides a comprehensive molecular subtyping approach, including a novel proliferation signature.
  • The APIS assay shows potential as a valuable tool for routine assessment of newly diagnosed breast cancer specimens.

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