ArticleBreast cancer research and treatment2018
Comparison of central laboratory assessments of ER, PR, HER2, and Ki67 by IHC/FISH and the corresponding mRNAs (ESR1, PGR, ERBB2, and MKi67) by RT-qPCR on an automated, broadly deployed diagnostic platform.
Article in Breast cancer research and treatment, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers.
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29 citing papers in PubMed, 54 citations in OpenAlex.
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- Prognostic impact of HER2 biomarker levels in trastuzumab-treated early HER2-positive breast cancer.Breast cancer research : BCR · 2024Article
- Immunohistochemistry versus PCR Technology for Molecular Subtyping of Breast Cancer: Multicentered Expereinces from Addis Ababa, Ethiopia.Journal of cancer prevention · 2023Article
- A predictor of response in HER2+ breast cancer-at last!Journal of the National Cancer Institute · 2023Article
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- Breast cancer molecular diagnostics in Rwanda: a cost-minimization study of immunohistochemistry versus a novel GeneXpertBulletin of the World Health Organization · 2023Article
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- The g3mclass is a practical software for multiclass classification on biomarkers.Scientific reports · 2022Article
- Relationship between ER expression by IHC or mRNA with Ki67 response to aromatase inhibition: a POETIC study.Breast cancer research : BCR · 2022Article
- Comparison of immunohistochemistry and RT-qPCR for assessing ER, PR, HER2, and Ki67 and evaluating subtypes in patients with breast cancer.Breast cancer research and treatment · 2022Article
- Development of an automated liquid biopsy assay for methylated markers in advanced breast cancer.Cancer research communications · 2022Article
- Correlation of ER, PR, and HER2 at the protein and mRNA levels in Asian patients with operable breast cancer.Bioscience reports · 2022Article
- Precision Medicine in Low- and Middle-Income Countries.Annual review of pathology · 2022Review
- The African Female Breast Cancer Epidemiology Study Protocol.Frontiers in oncology · 2022Article
- Assessment of estrogen receptor low positive status in breast cancer: Implications for pathologists and oncologists.Histology and histopathology · 2021Review
- Use of the Xpert Breast Cancer STRAT4 for Biomarker Evaluation in Tissue Processed in a Developing Country.American journal of clinical pathology · 2021Article
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20 authors at 7 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe methods (IHC/FISH) typically used to assess ER, PR, HER2, and Ki67 in FFPE specimens from breast cancer patients are difficult to set up, perform, and standardize for use in low and middle-income countries. Use of an automated diagnostic platform (GeneXpert®) and assay (Xpert® Breast Cancer STRAT4) that employs RT-qPCR to quantitate ESR1, PGR, ERBB2, and MKi67 mRNAs from formalin-fixed, paraffin-embedded (FFPE) tissues facilitates analyses in less than 3 h. This study compares breast cancer biomarker analyses using an RT-qPCR-based platform with analyses using standard IHC and FISH for assessment of the same biomarkers.
methodsFFPE tissue sections from 523 patients were sent to a College of American Pathologists-certified central reference laboratory to evaluate concordance between IHC/FISH and STRAT4 using the laboratory's standard of care methods. A subset of 155 FFPE specimens was tested for concordance with STRAT4 using different IHC antibodies and scoring methods.
resultsConcordance between STRAT4 and IHC was 97.8% for ESR1, 90.4% for PGR, 93.3% for ERBB2 (IHC/FISH for HER2), and 78.6% for MKi67. Receiver operating characteristic curve (ROC) area under the curve (AUC) values of 0.99, 0.95, 0.99, and 0.85 were generated for ESR1, PGR, ERBB2, and MKi67, respectively. Minor variabilities were observed depending on the IHC antibody comparator used.
conclusionEvaluation of breast cancer biomarker status by STRAT4 was highly concordant with central IHC/FISH in this blinded, retrospectively analyzed collection of samples. STRAT4 may provide a means to cost-effectively generate standardized diagnostic results for breast cancer patients in low- and middle-income countries.
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