Oxford, UK – 22 September 2025. OGT, a leading global provider of genomic diagnostic and research solutions, announced today that the U.S. Food and Drug Administration (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). Revuforj is FDA approved for the treatment of relapsed or refractory (R/R) acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients one year and older.
OGT’s CytoCell KMT2A Breakapart FISH Probe Kit PDx detects clinically relevant rearrangements that occur in patients with acute leukemia, providing a robust, accessible, rapid turnaround test for KMT2Ar detection that will maximize the ability for clinicians to quickly identify patients who may be eligible for treatment with Revuforj. It is estimated that more than 95% of patients with KMT2Ar acute leukemia have a KMT2A translocation, a type of rearrangement that occurs when part of one chromosome breaks and fuses to a different chromosome.
“We are delighted that our CytoCell KMT2A Breakapart FISH Probe Kit PDx has received marketing authorization as a CDx for Revuforj.” said Dr. Leila Luheshi, VP of Pharma Partnering at OGT. “The development and subsequent authorization of this new CDx is an important demonstration of the skill and commitment of our clinical scientists and regulatory specialists to deliver safe and effective diagnostics for patients with one of the most devastating forms of leukemia.”
Steve Chatters, OGT’s EVP of Regulatory and Medical Affairs noted “Our strong foundation in hematology diagnostics has been a key factor in our success bringing the KMT2Ar CDx to market as a Class II device, as opposed to the more common Class III classification for companion diagnostics. We have decades of experience developing regulated FISH products, gained from our prior development of IVDR-certified and FDA-cleared FISH probes. Combined with our extensive customer partnerships in hematology labs in the USA, we have refined insights into the application of these products and are able to access a wealth of real-world data across a multitude of clinical and analytical factors, which is invaluable for product development. This is a core pillar of our success."
The emergence of precision therapies, such as the menin inhibitor Revuforj (an oral inhibitor of the menin–KMT2A interaction), offers new avenues for potentially improving outcomes for patients with these challenging acute leukemia cases.
“Accurately identifying acute leukemia patients with KMT2Ar is a key factor in selecting appropriate therapeutic options for a group of patients who have traditionally had a very poor prognosis” said Adrian Smith, CEO of OGT. “We are optimistic that the authorization of OGT's CDx will help this underserved patient group benefit from developments in precision oncology.”
The KMT2A (lysine methyltransferase 2A) gene at 11q23.3 is commonly rearranged in acute leukemias, especially in infant leukemia. KMT2A rearrangements can be detected in approximately 70%-80% of infants with acute lymphoblastic leukemia (ALL) and in 5-10% of pediatric and adult ALLs1,2. They can also be found in more than 50% of infants with acute myeloid leukemia (AML) and is also seen in 10% of adolescents and 3-10% of adults with AML. KMT2A rearrangements are also seen in mixed-phenotype acute leukemia, a rare type of acute leukemia more common in infants and children than adults2. To date, more than 90 partners have been identified with the most common partner genes being AFF1 (4q21), MLLT3 (9p22) and MLLT1 (19p13.3)2.
The KMT2A Breakapart FISH Probe Kit PDx is a fluorescence in situ hybridization (FISH) test used to detect rearrangement of the KMT2A region on chromosome 11 at location 11q23.3 in 3:1 methanol/glacial acetic acid fixed bone marrow specimens from patients with acute leukemia with KMT2A rearrangement.
The assay is indicated for detecting the presence of rearrangements involving the KMT2A region as a companion diagnostic to aid in identifying those patients for whom treatment with REVUFORJ® (revumenib) is indicated in accordance with the approved therapeutic product labeling. The KMT2A Breakapart FISH Probe Kit PDx is not intended for monitoring of residual disease. Reporting and interpretation of FISH results should be performed by a qualified pathologist or cytogeneticist.
For In Vitro Diagnostic Use.
Caution: Federal law restricts this device to sale by or on the order of a physician. (Rx Only)
For full limitations and other information, see the device package insert or go www.ogt.com/kmt2a-pdx
OGT, a Sysmex Group company, is a leading global provider of clinical and diagnostic genomic solutions that are created for scientists by scientists - including CytoCell®, CytoSure® and SureSeq™ ranges of FISH, microarray and NGS products. The company is dedicated to creating products that enable researchers and clinical decision makers to reach the right care decisions for each patient, every time. OGT strives to unlock the future of genetic clinical care with a commitment to working in partnership with its customers - not only by sharing its expertise of 30 years at the forefront of genetic endeavor, but also by working closely with scientists to understand their unique challenges, and to customize its approach to meet their exact needs. With OGT’s precision medicine partnerships, we strive to accelerate clinical trial assay and companion diagnostic development programs to help our partners make the right decisions every time. Dedicated to improving clinical care, OGT believes that through partnership—together—we’ll achieve more.
CytoSure®, SureSeq™ and myProbes®: For Research Use Only, not for use in diagnostic procedures. CytoCell®: Some products may not be available in your region.
Sysmex Corporation, headquartered in Kobe, Japan, is a global leader in in vitro diagnostics. Since its foundation in 1968, Sysmex has focused on diagnostics as the core of its business, and today, it supports the health of people in over 190 countries and regions worldwide. Sysmex continues to innovate in diagnostics, and to collaboratively create unique values in the areas of personalized medicine and novel treatments, under its long-term vision of "Together for a better healthcare journey." Through its unique technology, solutions, and co-creation with various partners, Sysmex delivers new value and addresses the universal desire of people to live longer and healthier lives. The company employs more than 10,000 employees worldwide. Sysmex Corporation is listed in the Prime Market on the Tokyo Stock Exchange.
For more information about Sysmex Corporation and its affiliate companies, please visit www.sysmex.co.jp/en/.
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