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Introduction

This application note describes the detailed clinical and analytical studies carried out to meet the performance required to achieve FDA clearance of the eight probes for acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) listed in Table 1. In addition, we present data demonstrating excellent analytical reproducibility of the probes and extensive stability studies. During the course of these studies, which spanned four sites, worldwide, over 2,500 replicates were run with no technical failures. The rigorous standards required for gaining FDA clearance are recognized globally and emphasize the exceptional quality of the CytoCell® FISH probes from OGT.

Table 1. The eight FISH probes in this study.Table 1: The eight FISH probes in this study

*Kit includes FISH probe and DAPI

The CytoCell AML/MDS range of FISH probe test kits are fluorescence in situ hybridization (FISH) tests used to detect common chromosomal rearrangements in fixed bone marrow specimens from patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). The tests are indicated for the characterization of patient specimens consistent with World Health Organization guidelines for Classification of Tumours of Haematopoietic and Lymphoid Tissues (Revised 4th Edition) and in conjunction with other clinicopathological criteria. The assay results are to be interpreted by a qualified pathologist or cytogeneticist. The tests are not intended for use as a stand-alone diagnostic, disease screening, or as a companion diagnostic.

Refer to individual test kit Package Insert for the specific intended use and limitations. For In Vitro Diagnostic Use. Rx only.

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