Global Testing Service Advances Leukemia MRD Monitoring

KMT2A rearrangements drive aggressive subsets of acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL) and are associated with relapse and poor outcomes. As menin inhibitors enter clinical practice and expand in trials, clinicians and sponsors need standardized, highly sensitive tools to quantify measurable residual disease and monitor treatment response. A new service now provides high-sensitivity KMT2A MRD testing through an international laboratory network.

LabPMM, an Invivoscribe subsidiary, has launched a global KMT2A measurable residual disease (MRD) testing service based on digital PCR (dPCR). The service is available to healthcare providers, clinical researchers, and biopharmaceutical partners through LabPMM’s global laboratory network, with College of American Pathologists/Clinical Laboratory Improvement Amendments (CAP/CLIA)-accredited testing in the U.S. The offering is intended to support acute leukemia care and menin inhibitor development by enabling standardized molecular monitoring.

Image: The dPCR assay targets the most common KMT2A partner fusion genes found in AML and ALL, aligning with the disease biology relevant to current menin inhibitor programs (Image Credit: Shutterstock)

The dPCR assay targets the most common KMT2A partner fusion genes found in AML and ALL, aligning with the disease biology relevant to current menin inhibitor programs. It provides quantitative results, reported as the percentage of KMT2A rearrangements relative to a housekeeping gene, and supports both initial disease characterization and longitudinal measurable residual disease (MRD) monitoring.

The assay achieves an analytical sensitivity of 0.005%. Results may be available in as little as 48 hours, with a standard turnaround time of 7 to 10 business days. The launch expands Invivoscribe’s myeloid testing portfolio, which includes globally standardized molecular kits and LabPMM services for screening and MRD monitoring of FLT3, NPM1, and KMT2A rearrangements, as well as AML MRD assessment using multiparametric flow cytometry.

KMT2A rearrangements are oncogenic drivers found in approximately 80% of infant leukemia cases and 5–15% of childhood and adult leukemia cases. These alterations are associated with chemotherapy resistance, high relapse rates, and poor outcomes, underscoring the need for sensitive and standardized monitoring. The company notes that the first U.S. Food and Drug Administration (FDA) approval of a menin inhibitor for relapsed or refractory acute leukemia with a KMT2A translocation has provided clinical validation for this therapeutic class. Additional KMT2A partner fusion genes are expected to be added in early 2027, further expanding the assay’s coverage in ALL.

“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,” said Jeff Miller, CEO and CSO of Invivoscribe.

“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,” Miller added.