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Comprehensive and Accurate Molecular Profiling of Breast Cancer through mRNA Expression of ESR1, PGR, ERBB2, MKI67, and a Novel Proliferation Signature.
Wegscheider, Anne-Sophie; Gorniak, Joanna; Rollinson, Sara; Gough, Leanne; Dhaliwal, Navdeep; Guardiola, Agustin; Gasior, Anna; Helmer, Denise; Pounce, Zoe; Niendorf, Axel.
Afiliación
  • Wegscheider AS; MVZ Prof. Dr. Med. A. Niendorf Pathologie Hamburg-West GmbH, Institute for Histology, Cytology and Molecular Diagnostics, Lornsenstr. 4, 22767 Hamburg, Germany.
  • Gorniak J; APIS Assay Technologies Ltd., Second Floor, Citylabs 1.0, Nelson Street, Manchester M13 9NQ, UK.
  • Rollinson S; APIS Assay Technologies Ltd., Second Floor, Citylabs 1.0, Nelson Street, Manchester M13 9NQ, UK.
  • Gough L; APIS Assay Technologies Ltd., Second Floor, Citylabs 1.0, Nelson Street, Manchester M13 9NQ, UK.
  • Dhaliwal N; APIS Assay Technologies Ltd., Second Floor, Citylabs 1.0, Nelson Street, Manchester M13 9NQ, UK.
  • Guardiola A; APIS Assay Technologies Ltd., Second Floor, Citylabs 1.0, Nelson Street, Manchester M13 9NQ, UK.
  • Gasior A; APIS Assay Technologies Ltd., Second Floor, Citylabs 1.0, Nelson Street, Manchester M13 9NQ, UK.
  • Helmer D; MVZ Prof. Dr. Med. A. Niendorf Pathologie Hamburg-West GmbH, Institute for Histology, Cytology and Molecular Diagnostics, Lornsenstr. 4, 22767 Hamburg, Germany.
  • Pounce Z; APIS Assay Technologies Ltd., Second Floor, Citylabs 1.0, Nelson Street, Manchester M13 9NQ, UK.
  • Niendorf A; MVZ Prof. Dr. Med. A. Niendorf Pathologie Hamburg-West GmbH, Institute for Histology, Cytology and Molecular Diagnostics, Lornsenstr. 4, 22767 Hamburg, Germany.
Diagnostics (Basel) ; 14(3)2024 Jan 23.
Article en En | MEDLINE | ID: mdl-38337757
ABSTRACT

BACKGROUND:

An accurate status determination of breast cancer biomarkers (ER, PR, HER2, Ki67) is crucial for guiding patient management. The "gold standard" for assessing these biomarkers in FFPE tissue is IHC, which faces challenges in standardization and exhibits substantial variability. In this study, we compare the concordance of a new commercial RT-qPCR kit with IHC in determining BC biomarker status.

METHODS:

The performance was evaluated using 634 FFPE specimens, which underwent histological analysis in accordance with standard of care methods. HER2 2+ tumors were referred to ISH testing. An immunoreactive score of ≥2/12 was considered positive for ER/PR and 20% staining was used as a cut-off for Ki67 high/low score. RT-qPCR and results calling were performed according to the manufacturer's instructions.

RESULTS:

High concordance with IHC was seen for all markers (93.2% for ER, 87.1% for PR, 93.9% for HER2, 77.9% for Ki67 and 80.1% for proliferative signature (assessed against Ki67 IHC)).

CONCLUSIONS:

By assessing the concordance with the results obtained through IHC, we sought to demonstrate the reliability and utility of the kit for precise BC subtyping. Our findings suggest that the kit provides a highly precise and accurate quantitative assessment of BC biomarkers.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Diagnostics (Basel) Año: 2024 Tipo del documento: Article País de afiliación: Alemania Pais de publicación: Suiza

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Diagnostics (Basel) Año: 2024 Tipo del documento: Article País de afiliación: Alemania Pais de publicación: Suiza