Assay Description:

The SCALPEL (Single Cell Analysis of Limited Protein Expression Levels) assay is an advanced cytometry solution to detect cell types based on their activated signaling pathways. It represents a novel application of high parameter flow cytometry to detect, quantify, and characterize functionally activated cell types. The assay enables identification of pathologically activated progenitor cell types in blood cancers (e.g. chronic myeloid leukemia), and activated basophils in allergic disorders.

When a growth factor or cytokine (or certain exogenous triggers) binds to its cell surface receptor, a cascade of tightly regulated signaling events ensue within the cell cytoplasm. Multiple kinases get sequentially phosphorylated transmitting the signal into the nucleus, and promoting gene and protein expression. With the SCALPEL test, detailed characterization of the proliferative clone(s) or pathologically activated cells can be performed by massively multiplexed immunophenotypic analysis of cell-specific profiles of regulatory proteins within activated networks. The assay aims to identify activated cells using cell-based protein biomarkers and decipher cellular components of the immune response in leukemic and non-leukemia conditions. When integrated with other laboratory data, the results allow better assessment of the disease state, monitor treatment response, and determine the cause of recurrence. As such, it can be a predictive test that enables better treatment strategies.

Data analysis is performed by Eyelis high-dimensional analysis and visualization software. These algorithms enable feature selection and automated pattern-based classification of cells identified by high parameter cytometry. The analysis improves accuracy of cell identification, and generates intuitive data displays to facilitate interpretation of high dimensional data.