FDA Grants De Novo Designation for OGT’s AML/MDS FISH Probes

Oxford Gene Technology (OGT), The Molecular Genetics Company, has been granted de novo classification by the US Food and Drug Administration (FDA) for eight Cytocell Aquarius® Haematology fluorescence in situ hybridization (FISH) probes for acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). The probes form the largest FDA-cleared in vitro diagnostic (IVD)* FISH probe range for AML and MDS on the market and will address a substantial proportion of diagnostic laboratory hematological 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 full list of FDA-cleared Cytocell Aquarius FISH probes is:

• AML1/ETO (RUNX1/RUNX1T1) Translocation, Dual Fusion
• CBFβ (CBFB)/MYH11 Translocation, Dual Fusion
• Del(5q) Deletion
• Del(7q) Deletion
• Del(20q) Deletion
• EVI1 (MECOM) Breakapart
• MLL (KMT2A) Breakapart
• P53 (TP53) Deletion

The probes are supplied pre-mixed and ready-to-use as part of a complete kit including DAPI, detailed protocols and signal pattern analysis guidelines which streamlines processing and minimizes errors – delivering increased convenience and reliable results. 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 renowned expert technical support, enabling laboratories to remain focused on delivering high quality, rapid results to their patients.

“We’re delighted to bring our comprehensive range of FDA-cleared AML and MDS FISH probes to market”, commented Steve Chatters, Director of Medical Affairs at Oxford Gene Technology. “The rigorous FDA de novo pathway requires the submission of extensive clinical and performance data from multiple sites, along with robust evidence of the safety and effectiveness of the probes. What this means for customers, particularly in the US, is a significant reduction in the validation burden and immediate access to a range of high-quality IVD probes covering a comprehensive set of rearrangements. Our customers will be able to easily and accurately detect pertinent chromosomal rearrangements in fixed bone marrow specimens without needing to complete lengthy validations for every probe prior to use.”

Dr John Anson, CEO at OGT added, “Gaining FDA clearance for this range of probes is a real milestone for OGT and our customers, demonstrating our continued commitment to developing and providing molecular diagnostic solutions as part of Sysmex. We see FISH technology very much as a long-term diagnostic solution and we are committed to continuing to expand the Cytocell portfolio with new diagnostic products. This is a significant step towards achieving that goal, immediately benefiting our customers by providing access to the largest range of FDA-cleared FISH probes for AML and MDS currently on the market.”

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