FDA clears new companion diagnostic for KMT2A acute leukaemia

OGT, a global provider of genomic diagnostic and research solutions, has announced that the US Food and Drug Administration (FDA) has granted De Novo authorisation for its CytoCell® KMT2A Breakapart FISH Probe Kit PDx as a companion diagnostic (CDx) for Syndax’s Revuforj® (revumenib). Revuforj is approved for the treatment of relapsed or refractory acute leukaemia in patients with KMT2A translocations, including adults and children aged one year and older.

The CytoCell KMT2A Breakapart FISH Probe Kit PDx enables rapid and reliable detection of KMT2A rearrangements (KMT2Ar), helping clinicians identify patients who may benefit from Revuforj therapy. KMT2A translocations are present in over 95% of patients with KMT2Ar acute leukaemia, making timely and accurate testing essential for precision oncology.

By combining OGT’s extensive experience in haematology diagnostics with proven FISH technology, the assay delivers quick turnaround and accessible testing in clinical laboratories. Its use as a CDx supports targeted therapy decisions and provides critical insights for treating a patient group with historically poor outcomes.

“Obtaining FDA authorisation for this companion diagnostic marks an important milestone for our clinical and regulatory teams,” said Dr Leila Luheshi, VP Pharma Partnering at OGT. “The test will help ensure that eligible patients can access Revuforj safely and efficiently.”

The CytoCell KMT2A Breakapart FISH Probe Kit PDx is indicated solely as a companion diagnostic to guide Revuforj treatment. Reporting and interpretation should be performed by qualified pathologists or cytogeneticists.  

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