ArticleAmerican journal of clinical pathology2021
Use of the Xpert Breast Cancer STRAT4 for Biomarker Evaluation in Tissue Processed in a Developing Country.
Article in American journal of clinical pathology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.
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Who cites it
7 citing papers in PubMed, 19 citations in OpenAlex.
- HER2 testing: evolution and update for a companion diagnostic assay.Nature reviews. Clinical oncology · 2025Review
- Xpert Breast Cancer STRAT4 Assay using fine-needle aspiration biopsy samples in a resource-constrained setting: a prospective diagnostic accuracy study.The Lancet. Oncology · 2024Article
- Article
- Evaluation ofCancers · 2023Article
- Breast cancer molecular diagnostics in Rwanda: a cost-minimization study of immunohistochemistry versus a novel GeneXpertBulletin of the World Health Organization · 2023Article
- XPERTEcancermedicalscience · 2023Article
- Leveraging Molecular Diagnostic Technologies to Close the Global Cancer Pathology Gap.JCO global oncology · 2022Article
Corrections and comments
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Authors and funding
12 authors at 4 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesBreast cancer immunohistochemistry (IHC) biomarker testing is limited in low-resource settings, and an alternative solution is needed. A point-of-care mRNA STRAT4 breast cancer assay for ESR1, PGR, ERBB2, and MKi67, for use on the GeneXpert platform, has been recently validated on tissues from internationally accredited laboratories, showing excellent concordance with IHC.
methodsWe evaluated STRAT4/IHC ESR1/estrogen receptor (ER), ERBB2/human epidermal growth factor receptor 2 (HER2) concordance rates of 150 breast cancer tissues processed in Rwanda, with undocumented cold ischemic and fixation time.
resultsAssay fail/indeterminate rate was 2.6% for ESR1 and ERBB2. STRAT4 agreement with ER IHC was 92.5% to 93.3% and 97.8% for HER2, for standard (1x) and concentrated (4x) reagent-conserving protocols, respectively. Eleven of 12 discordant ER/ESR1 cases were ESR1- negative/IHC-positive. These had low expression of ER by IHC in mostly very small tumor areas tested (7/12; <25 mm2). In two of three discordant HER2 cases, the STRAT4-ERBB2 result correlated with the subsequent fluorescence in situ hybridization (FISH) result. STRAT4-ERBB2 results in 9 of 10 HER2-IHC equivocal cases were concordant with FISH.
conclusionsThe STRAT4 assay is an alternative for providing quality-controlled breast cancer biomarker data in laboratories unable to provide quality and/or cost-efficient IHC services.
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