Flow cytometry affords outstanding statistical power to detect rare cell populations and quantify cellular phenotypes in biological samples for both pre-clinical and clinical applications. However, flow cytometric methods can be extremely challenging to develop and validate, especially given the complexity of the measurements involved and the lack of standardized cellular reference materials.
Assay validation is performed to demonstrate that the adopted method displays the required performance characteristics over the designated range of conditions of the study. Since flow cytometry is considered an analytical method, the FDA requires that clinical flow cytometric studies meet specific analytical method validation criteria to confirm that the process is fit for its intended use:
Matrix selection (whole blood, PBMCs, tissue). GLP sample handling/ processing, sample stability assessment
Fit for Purpose High Dimensional Flow Cytometry Method Design, Optimization and Validation for clinical and diagnostic research programs
Quality Management Systems Regulatory Expertise: GLP, GcLP, CLIA to ensure full compliance with regulatory guidelines and principals
Advanced Analytics for Exploratory and Clinical EndPoints. Dedicated analytical team for consistent, reliable and fast data turn-around.