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CytoCell® KMT2A Breakapart FISH Probe Kit PDx Receives U.S. FDA Premarket Authorization (De Novo) - Contributing to Expanded Treatment Opportunities for Patients with Acute Leukemia - (OGT)
OGT, a Sysmex Group company, today announced that it has received premarket authorization under the U.S. Food and Drug Administration (FDA) De Novo pathway1 on September 22, 2025, for its CytoCell® KMT2A Breakapart FISH Probe Kit PDx.2
This authorization enables the use of the kit in the United States as a companion diagnostic (CDx) for Revuforj (generic name: revumenib, Syndax Pharmaceuticals) in patients with KMT2A- rearranged (KMT2Ar) acute leukemia3. The product supports highly sensitive and accurate detection of KMT2A gene rearrangements, contributing to improved treatment opportunities for patients. For further details, please refer to OGT’s press release.
▶ OGT News Release, September 22, 2025 (https://www.ogt.com/about-us/news/u-s-food-and-drug-administration-authorizes-cytocell-kmt2a-breakapart-fish-probe-kit-pdx/)
Terminology
| 1 | De Novo Authorization: | |
| A regulatory pathway by the U.S. FDA for novel medical devices for which no substantially equivalent predicate exists in the U.S. market. Products granted De Novo authorization are classified as Class I or II after safety and effectiveness have been demonstrated and serve as predicates for future devices of the same type. | ||
| 2 | CytoCell® KMT2A Breakapart FISH Probe Kit PDx: | |
| An in vitro diagnostic kit provided by OGT, based on fluorescence in situ hybridization (FISH). It is designed to detect KMT2A gene rearrangements in bone marrow samples from patients with acute leukemia, supporting highly sensitive and accurate diagnosis. | ||
| 3 | KMT2A-rearranged (KMT2Ar) acute leukemia: | |
| KMT2A gene rearrangements are frequently observed in acute leukemia, including in infants, and significantly impact treatment and prognosis. They are detected in acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), and mixed phenotype acute leukemia (MPAL), involving multiple partner genes. |
- The purpose of this news is to communicate our business activities to our stakeholders. It may or may not include information about Sysmex's products or their research and development, but this is not intended for promotion, advertising, or medical advice. The information contained in this press release is current as of the date of the announcement but may be subject to change without prior notice.