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Subspecialties Oncology

A New Look at Leukemia and Lymphoma

Flow cytometry is an example of a rapidly evolving IVD technology that is migrating from the highly specialized laboratory to routine clinical testing in the core lab.  It has been widely adopted for the assessment of leukemias and lymphomas and is part of the trend toward early detection and monitoring, bringing diagnostics closer to patients. 2017 marked a milestone for the technology when the US Food and Drug Administration (FDA) granted de novo authorization for the in vitro diagnostic use of the first pre-formulated antibody cocktail for leukemia and lymphoma immunophenotyping.

Flow cytometric immunophenotyping evaluates the presence and absence of specific antigens for each individual cell in the specimen.  Interpretation of aberrant immunophenotypes requires skill in recognizing the significance of different patterns.  As part of the test manufacturer’s available information, a unique case book has been created to aid in this complex pattern recognition. The following case is just one example.

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