Rare Event Analysis in Flow Cytometry: Design Control and Validation Aligned with CLSI H62

April 5, 2023

Dr. Virginia Litwin

Rare event analysis by flow cytometry is relatively common in research settings, in clinical laboratories and during drug discovery and development. For example, in research and drug discovery environments, the measurement of intracellular cytokines and intracellular signaling events (i.e., protein phosphorylation) are some of the more common rare event assays. Whereas in clinical laboratories, assays for rare events often include the measurement of CD34⁺ hematopoietic stem cells, paroxysmal nocturnal hemoglobinuria (PNH) and minimal residual disease (MRD) of blood cancers. During drug development and clinical trial evaluation of new therapeutic modalities, rare event methods might also include the monitoring of CAR cellular therapies and the efficacy of cell-depleting therapies.

Flow cytometry is considered an ideal technology for the detection of rare populations of cells. Not only can multiple characteristics on individual cells be measured, but also a large number of cells can be evaluated in a relatively short amount of time. However, as the technology moves out of research and non-regulated settings into clinical laboratories and the regulated phases of preclinical and clinical drug development, concerns related to how to develop, validate and implement robust assays for rare event measurements arise.

This webinar will address those concerns by introducing the concept Design Control and how its application can facilitate assay development and validation. Design Control is a structured process which is applied to the conduct of product development activities. While Design Control is mandatory in regulated industries, it can be easily adopted in non-regulated settings to increase successful outcomes.