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- W2892029013 abstract "Breast cancer hormone receptor status, including estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2), is critical in determining patient prognosis and treatment. Reagent shortages, lack of trained staff, and long processing time limit their assessment in Tanzania. We aim to compare GeneXpert Breast Cancer STRAT4 (Research Use Only) assay using fine-needle aspiration (FNA) specimens to immunohistochemistry (IHC) on corresponding mastectomy specimens. STRAT4 measures the mRNA of biomarkers on an automated qPCR diagnostic platform. Adult patients presenting to the FNA Clinic at Muhimbili National Hospital (MNH) with a malignant breast mass based on rapid on-site evaluation (ROSE) were recruited prospectively. Patients with a history of breast cancer, those with bilateral breast tumors, and women who were pregnant or lactating were excluded. STRAT4 was performed on air-dried FNA specimens at MUHAS and compared with ER, PR, and HER2 IHC results on corresponding surgical specimens. Twenty patients have been recruited to date (age range, 25–75; mean age, 48.8 years). All cases determined to be adenocarcinoma by ROSE were confirmed to be adenocarcinoma on final report. STRAT4 assay showed four triple negative, six ER+PR+HER2+, two ER+PR+HER2–, five ER+PR–HER2+, two ER+PR–HER2–, and one ER–PR–HER2+. Four cases have IHC results from MNH; rates of misclassification were 0% for ER, 50% for PR, and 50% for HER2. Average biomarker turnaround time with FNA and STRAT4 was 4.7 days (range, 1–14 days), compared to 37 days (range, 32–43 days) with IHC on surgical specimens from date of procedure. STRAT4 assay can be implemented with fewer resources and accelerated timeline as compared to IHC at MNH. ER has a low rate of misclassification. Implementation of STRAT4 technology has the potential to transform breast cancer diagnosis and treatment in low-resource settings." @default.
- W2892029013 created "2018-09-27" @default.
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- W2892029013 date "2018-09-21" @default.
- W2892029013 modified "2023-10-17" @default.
- W2892029013 title "Validation of the GeneXpert Breast Cancer STRAT4 Assay for Rapid Analysis of Breast Cancer Biomarker Status From Fine-Needle Aspiration Biopsies in Tanzania (GX-BCB): Preliminary Results" @default.
- W2892029013 doi "https://doi.org/10.1093/ajcp/aqy104.330" @default.
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