The digital PCR service aims to support the development of menin inhibitors and improve monitoring for patients with KMT2A-rearranged disease.

LabPMM, a subsidiary of Invivoscribe, has announced the global availability of its KMT2A measurable residual disease (MRD) testing service. The digital polymerase chain reaction (PCR) service is available to healthcare providers, clinical researchers, and biopharmaceutical partners through the global laboratory network of LabPMM, with CAP/CLIA-accredited testing available in the US.

The service addresses a growing need for accurate molecular monitoring in acute leukemias. KMT2A rearrangements are oncogenic drivers in acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). These rearrangements are present in approximately 80% of infant cases and 5-15% of childhood and adult leukemia cases. According to the company, these leukemias are associated with chemotherapy resistance, high relapse rates, and poor clinical outcomes.

Supporting Menin Inhibitor Development

The emergence of menin inhibitors is changing the therapeutic landscape for patients with AML and ALL, specifically those with KMT2A-rearranged and NPM1-mutated disease. The Food and Drug Administration recently granted the first approval of a menin inhibitor for relapsed or refractory acute leukemia with a KMT2A translocation.

As menin inhibitor programs move into frontline and combination studies, there is an increasing requirement for molecular testing that can characterize KMT2A rearrangements, quantify deep molecular response, and track the durability of that response over time.

“Menin inhibitors are creating important new possibilities for patients with KMT2A-rearranged leukemia, but continued development requires a partner that can deliver highly sensitive, standardized molecular data across clinical programs and geographies,” says Jeff Miller, CEO and chief science officer of Invivoscribe, in a release. “By making KMT2A MRD testing available through LabPMM, we are helping clinicians and biopharmaceutical partners measure meaningful responses earlier, monitor their durability, and ultimately improve patient care.”

Standardized Testing and Sensitivity

The new test targets common KMT2A partner fusion genes in AML and ALL, aligning the assay with the biology central to many current menin inhibitor development programs. The test provides a quantitative result reported as the percentage of KMT2A rearrangements relative to a housekeeping gene.

The assay supports disease characterization and longitudinal MRD monitoring with sensitivity down to 0.005%. While the standard turnaround time is seven to 10 business days, results can be reported in as little as 48 hours.

The launch expands the company’s myeloid testing portfolio, which includes standardized molecular assay kits and services for screening and MRD monitoring of FLT3, NPM1, and KMT2A rearrangements, as well as AML MRD assessment by multiparametric flow cytometry. According to the company, these integrated capabilities allow drug developers and healthcare providers to monitor disease burden over time.

ID 88378347 © ibreakstock | Dreamstime.com

References

  1. Dillon, L. et al. JAMA Oncol. 2024;10;(8):1104-1110. https://doi.org/10.1001/jamaoncol.2024.0985
  2. Levis, M., et al. Blood. 2025;145(19):2138-2148 https://doi.org/10.1182/blood.2024025154
  3. Hourigan CS, et al. Blood. 2025;145(19)2105-2106. https://doi.org/10.1182/blood.2024028105
  4. Petersen, L. et al. J Mol Diag. 2025;27(10)989-1002. https://doi.org/10.1016/j.jmoldx.2025.06.007
  5. Yin, L. et al. Cancer Med. 2024;13(20):e70326. https://doi.org/10.1002/cam4.70326
  6. Al-Ali, R. et al. Bone Marrow Transplant. 2025;61:222-224. https://doi.org/10.1038/s41409-025-02757-1
  7. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-revumenib-relapsed-or-refractory-acute-leukemia-KMT2A-translocation