Related Experiment Video
Updated: Jun 11, 2025
Long-term Culture of Human Breast Cancer Specimens and Their Analysis Using Optical Projection Tomography
Published on: July 29, 2011
Xpert Breast Cancer STRAT4 Assay using fine-needle aspiration biopsy samples in a resource-constrained setting: a
Dianna L Ng1, Edda Vuhahula2, Asteria H Kimambo2
1Department of Pathology, University of California, San Francisco, San Francisco, CA, USA; Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco, CA, USA; Department of Pathology and Laboratory Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Fine-needle aspiration biopsy (FNAB) processing with the Xpert Breast Cancer STRAT4 Assay is feasible in Tanzania, showing robust performance for estrogen receptor testing. This approach can enhance breast cancer diagnostic access in resource-limited settings.
Area of Science:
- Oncology
- Pathology
- In-vitro diagnostics
Background:
- Fine-needle aspiration biopsy (FNAB) is a minimally invasive technique for obtaining tissue samples.
- The Xpert Breast Cancer STRAT4 Assay (STRAT4) is an in-vitro diagnostic device for breast cancer biomarker testing.
- Resource-constrained settings face challenges in accessing advanced breast cancer diagnostic tools.
Purpose of the Study:
- To evaluate the performance of a research-use-only STRAT4 assay using FNAB specimens in Tanzania.
- To assess the feasibility and accuracy of STRAT4 for breast cancer biomarker testing in a resource-limited environment.
Main Methods:
- A prospective diagnostic accuracy study was conducted at Muhimbili National Hospital, Tanzania.
- Patients with palpable breast masses underwent FNAB; samples were tested using STRAT4 with four protocols (1× FNAB, quick lysis, Maui, 1× cell block).
- STRAT4 performance was compared against immunohistochemistry (IHC) or IHC plus fluorescence in-situ hybridization (FISH) as the reference standard.
Main Results:
- For estrogen receptor, 1× FNAB achieved 95% concordance, 94% sensitivity, and 97% specificity.
- For progesterone receptor, 1× cell block showed 89% concordance, 91% sensitivity, and 89% specificity.
- Maui protocol demonstrated high agreement for HER2 (93% concordance, 96% sensitivity) and Ki67 (73% concordance, 70% sensitivity).
Conclusions:
- Processing FNAB samples with STRAT4 is feasible in Tanzania, demonstrating robust performance for estrogen receptor.
- The STRAT4 assay holds potential for improving timely breast cancer diagnostics in resource-constrained settings.
- Further optimization of STRAT4 for FNAB samples could significantly enhance access to essential cancer biomarkers.
