Approaches to overcome the challenge of sample stability for flow cytometry analysis in clinical trials


A Hays | Bioanalysis, 13(21), 1587-1589 (2021)

Keywords: • biomarkers • cell fixation • clinical trials • flow cytometry • sample stability

Flow cytometry is a technology that has been increasingly valuable in support of biomarker analysis for clinical trials. It has many clinical applications including the ability to provide data to support safety or exploratory studies by utilizing basic or complex immunophenotyping, pharmacokinetic, receptor occupancy, target engagement, cell activation, functional and intracellular expression assays. The assays on this platform often provide important data in support of clinical trials, and thus it is important to ensure the data generated is of good quality. Flow cytometry is inherently complex in nature due to the inherent biological variability of cells. The technology itself also has its challenges in that the cytometer setup requirements are complex. The intricacy of data output and interpretation of results adds another layer of complexity. Aside from these obvious complexities of the technology itself, sample stability is a big challenge for flow cytometry given the fact that there is a time window in which cells begin to deteriorate once removed from the body.

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