Oxford Gene Technology (OGT) has been granted de novo classification by the US Food and Drug Administration (FDA) for eight Cytocell Aquarius haematology fluorescence in situ hybridisation (FISH) probes for acute myeloid leukaemia (AML) and myelodysplastic syndromes (MDS). The probes form the largest FDA-cleared in vitro diagnostic (IVD) FISH probe range for AML (pictured) and MDS on the market and will address a substantial proportion of diagnostic laboratory haematological FISH testing.
The cleared probes will significantly reduce the level of validation required in laboratories and provide accurate, easy-to-interpret detection of chromosomal rearrangements reported in AML and MDS.
The probes are supplied premixed and ready to use as part of a complete kit including DAPI, detailed protocols and signal pattern analysis guidelines, which streamlines processing and minimises errors. Bright, tight and high-intensity signals with excellent contrast all simplify analyses for confident results, while decreasing retest rates.
All Cytocell FISH probe users also benefit from OGT’s expert technical support, enabling laboratories to remain focused on delivering high-quality, rapid results to their patients.
