22/09/2025
OGT is proud to announce that the U.S. Food and Drug Administration (U.S. FDA) has granted their De Novo Classification Request for the CytoCell® KMT2A Breakapart FISH Probe Kit PDx as a companion diagnostic (CDx) for Syndax’s first-in-class menin inhibitor, REVUFORJ® (revumenib).
This decision by the U.S. FDA is an important demonstration of the skill and commitment of OGT’s clinical scientists and regulatory specialists to deliver safe and effective diagnostics for patients with one of the most devastating forms of leukaemia.
Read the full news article: https://www.ogt.com/about-us/news/u-s-food-and-drug-administration-authorizes-cytocell-kmt2a-breakapart-fish-probe-kit-pdx/?utm_source=Facebook&utm_medium=organic-social&utm_campaign=cytocell-kmt2a-pdx-pr-sep25
For In Vitro Diagnostic Use. Rx Only. For indications, limitations and other information, see the device package insert or go to www.ogt.com/kmt2a-pdx