Publications by authors named "Kenneth E Ho"
Article Synopsis
- A study was conducted to evaluate the STRAT4 Assay's effectiveness using fine-needle aspiration biopsy (FNAB) samples for breast cancer testing in Tanzania, aiming to improve biomarker accessibility in low-resource settings.
- The research involved collecting FNAB specimens from patients with palpable breast masses, using various testing protocols and excluding those with previous breast cancer diagnoses or specific conditions like pregnancy.
- The analysis compared STRAT4's performance against established testing methods based on factors like concordance, sensitivity, specificity, and diagnostic accuracy over a three-year period involving 208 patients.
Objectives: Breast 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.
Methods: We 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.
Purpose: The 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.
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