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

Investigator: Dianna Ng, MD
Sponsor: Cepheid

Location(s): Tanzania


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.