Reducing your FISH probe validation burden: Cytocell Aquarius^® AML and MDS FDA-cleared FISH probes

contributed by Oxford Gene Technology | 05/08/2019

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 Oxford Gene Technology (OGT).

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