Potential and challenges of clinical high-dimensional flow cytometry: A call to action.

Autor: Liechti T; Translational Medicine, Genentech, San Francisco, California, USA., Lelios I; Roche Pharma Research and Early Development, Roche Innovation Center Basel, Basel, Switzerland., Schroeder A; Translational Medicine, Genentech, San Francisco, California, USA., Decman V; Cellular Biomarkers, GSK, Collegeville, Pennsylvania, USA., Gonneau C; Labcorp, Geneva, Switzerland., Groves C; Translational Science and Innovation Laboratory, Q2 Solutions, Durham, North Carolina, USA., Green C; Translational Science, Ozette, Seattle, Washington, USA., Alcaide EG; Roche Pharma Research and Early Development, Roche Innovation Center Basel, Basel, Switzerland.
Jazyk: angličtina
Zdroj: Cytometry. Part A : the journal of the International Society for Analytical Cytology [Cytometry A] 2024 Nov; Vol. 105 (11), pp. 829-837. Date of Electronic Publication: 2024 Oct 23.
DOI: 10.1002/cyto.a.24902
Abstrakt: Clinical biomarker strategies increasingly integrate translational research to gain new insights into disease mechanisms or to define better biomarkers in clinical trials. High-dimensional flow cytometry (HDFCM) holds the promise to enhance the exploratory potential beyond traditional, targeted biomarker strategies. However, the increased complexity of HDFCM poses several challenges, which need to be addressed in order to fully leverage its potential and to align with current regulatory requirements in clinical flow cytometry. These challenges include among others extended timelines for assay development and validation, the necessity for extensive knowledge in HDFCM, and sophisticated data analysis strategies. However, no guidelines exist on how to manage such challenges in adopting clinical HDFCM. Our CYTO 2024 workshop "Potential and challenges of clinical high-dimensional flow cytometry" aimed to find consensus across the pharmaceutical industry and broader scientific community on the overall benefits and most urgent challenges of HDFCM in clinical trials. Here, we summarize the insights we gained from our workshop. While this report does not provide a blueprint, it is a first step in defining and summarizing the most pressing challenges in implementing HDFCM in clinical trials. Furthermore, we compile current efforts with the goal to overcome some of these challenges. As such we bring the scientific community and health authorities together to build solutions, which will accelerate and simplify the full adoption of HDFCM in clinical trials.
(© 2024 International Society for Advancement of Cytometry.)
Databáze: MEDLINE
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