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Diagnostics Biochemistry and molecular biology, Hematology, Technology and innovation, Oncology

Go with the Flow

sponsored by Beckman Coulter

Laboratory medicine professionals involved in the diagnosis of leukemia and lymphoma will be familiar with the immunohistochemistry (IHC) techniques used to spot these diseases. It’s likely that they are also familiar with flow cytometric immunophenotyping (FCI), an approach that – although less common – carries significant advantages.

In 2013, the FDA held a workshop that brought together laboratorians dealing with the complexities and expense of laboratory-developed flow cytometric tests (LDTs), clinicians relying on correct diagnoses to drive discovery and individual patient treatment, and regulatory agencies concerned with the safety risk posed by non-standardized assays. As a result of that workshop, Beckman Coulter Life Sciences pursued a de novo pathway to bring to market first the original five-color ClearLLab assay and, ultimately, ClearLLab 10C.

Each ClearLLab antibody combination is designed to characterize expected normal cells in a sample, while simultaneously highlighting and characterizing aberrant cells. Every tube contains CD34 and CD45 for the detection of blast populations and their cells of origin, and the tubes’ design also allows maturation sequences to be identified, a key method for detecting abnormal populations. The ClearLLab 10C system’s standardized instrument setup, 10-color control material, and analysis templates reduce the learning curve and make FCI more readily available to laboratories. Mike Keeney, Coordinator for Investigational Hematology and Associate Scientist at the London Health Sciences Center, and Jeannine Holden, Chief Medical Officer and Vice President of Scientific and Medical Affairs at Beckman Coulter Diagnostics, discuss the advantages of this approach.

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About the Authors

Mike Keeney

Coordinator for Investigational Hematology and Associate Scientist at the Lawson Health Research Institute, London Health Sciences Center, London, Canada.


Jeannine Holden

Chief Medical Officer and Vice President of Scientific and Medical Affairs at Beckman Coulter Diagnostics, Miami, USA.

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