FNAB samples with the STRAT4 assay for breast cancer diagnosis – Authors' reply
| dc.contributor.author | Vuhahula,Edda A.M. | |
| dc.date.accessioned | 2025-04-03T11:31:12Z | |
| dc.date.available | 2025-04-03T11:31:12Z | |
| dc.date.issued | 2025-01-26 | |
| dc.description.abstract | We thank Liqi Li for noting the myriad challenges of implementing leapfrog technologies in a resource-constrained setting. To clarify, our expectation in this pilot study,1 was not to demonstrate high levels of concordance for all biomarkers across all lysate preparation conditions. Our aims were: (1) to test different lysate preparation conditions to identify the optimal method that would facilitate use of off-label fine-needle aspiration biopsy (FNAB) specimens with the Xpert Breast Cancer STRAT4 Assay (STRAT4; Cepheid, Sunnyvale, CA, USA) in a resource-constrained setting; and (2) to assess whether similar concordance levels between results using FNAB specimens and previous results using formalin-fixed paraffin embedded specimens could be achieved.2 Previous studies of STRAT4 in sub-Saharan Africa have also explored multiple preparation methods to establish whether alternative, more reagent-efficient methods could be used.3,4 Although the inability to test all the samples using all sample preparation methods limited the ability to directly compare each method's performance, a sufficient number of samples were collected to assess each sample type independently. The College of American Pathologists (CAP) provides rigorous guidelines on anatomic pathology test validation.5 Using immunohistochemistry and fluorescence in-situ hybridisation results from another accredited laboratory as a reference standard during assay validation is a CAP-recommended practice. We also previously acknowledged that convenience sampling can introduce bias. Random sampling would not have been feasible in our study while ensuring the prospective collection of enough samples in a timely manner. The robust performance of STRAT4 for oestrogen receptor alone has the potential to markedly increase access to life-prolonging endocrine therapies in resource-constrained settings. However, the more modest performance of the other biomarkers reflect the need for additional FNAB lysis method optimisation before broader implementation. Additional studies evaluating real-world performance in resource-constrained settings will also be an essential next step. Our study provides an example of how leapfrog technologies for cancer diagnosis can be successfully investigated, using rigorous methodology, within a resource-constrained setting. | |
| dc.identifier.citation | g, D.L., Van Loon, K., Weidler, J., Bates, M., Mmbaga, E.J. and Vuhahula, E., 2025. FNAB samples with the STRAT4 assay for breast cancer diagnosis-Authors' reply. The Lancet. Oncology, 26(1), p.e10 | |
| dc.identifier.other | DOI: 10.1016/S1470-2045(24)00721-6 | |
| dc.identifier.uri | http://kuir.ku.ac.tz:4000/handle/123456789/1501 | |
| dc.language.iso | en | |
| dc.publisher | The Lancet. Oncology | |
| dc.subject | FNAB samples | |
| dc.subject | Breast cancer diagnosis | |
| dc.subject | STRAT4 assay | |
| dc.title | FNAB samples with the STRAT4 assay for breast cancer diagnosis – Authors' reply | |
| dc.type | Article |