LabPMM® Launches Global KMT2A MRD Testing Service to Support Menin Inhibitor Development and Acute Leukemia Care

SAN DIEGO--(BUSINESS WIRE)--LabPMM^®, an Invivoscribe^® subsidiary, today announced the global availability of its new KMT2A measurable residual disease (MRD) testing service. The highly sensitive digital PCR service is available to healthcare providers, clinical researchers, and biopharmaceutical partners through LabPMM’s global laboratory network, with CAP/CLIA-accredited testing available in the U.S. The service addresses a growing need for accurate molecular monitoring in acute leukemias.^1,2,3

KMT2A rearrangements (KMT2Ar) are oncogenic drivers in acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL).⁴ These rearrangements are present in about 80% of infant cases and 5-15% of childhood and adult leukemia cases.⁵ KMT2Ar leukemias are associated with chemotherapy resistance, high relapse rates, and poor clinical outcomes.⁵

The emergence of menin inhibitors is transforming the therapeutic landscape for patients with AML and ALL, particularly those with KMT2A-rearranged and NPM1-mutated disease.⁶ The first FDA approval of a menin inhibitor for relapsed or refractory acute leukemia with a KMT2A translocation established clinical validation for this emerging drug class.⁷ As menin inhibitor programs move into frontline and combination studies, there is an increasing need for sensitive molecular testing that can accurately characterize KMT2Ar, quantify deep molecular response, and track response durability over time.

Standardized MRD Testing for Global Clinical Development

LabPMM’s new test targets the most common KMT2A partner fusion genes in AML and ALL,⁸ aligning the assay with the KMT2A biology central to many current menin inhibitor development programs. The test provides a quantitative result reported as the percentage of KMT2Ar relative to a housekeeping gene. The assay supports disease characterization and longitudinal MRD monitoring with sensitivity down to 0.005% and a turnaround time in as little as 48 hours.⁹ This launch expands Invivoscribe’s comprehensive myeloid testing portfolio, which includes globally standardized molecular assay kits and LabPMM services for screening and MRD monitoring of FLT3, NPM1, KMT2Ar, as well as AML MRD assessment by multiparametric flow cytometry. Together, these integrated capabilities enable drug developers and healthcare providers to monitor disease burden over time with unprecedented sensitivity and accuracy.

“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.”

Together, Invivoscribe and LabPMM provide an integrated global ecosystem of standardized MRD testing, regulatory expertise, and companion diagnostic capabilities. Highly sensitive MRD testing can help define molecular response depth, evaluate response durability, support patient stratification, and accelerate trials when used as surrogate endpoints. By generating consistent molecular data across global clinical programs, this integrated approach helps sponsors make earlier, more informed decisions and reduce development risk from early clinical studies through regulatory submission, approval, and commercialization.

Healthcare providers and biopharmaceutical sponsors developing menin inhibitors for acute leukemia or other immunotherapies can contact Invivoscribe to discuss our global testing programs. Visit www.invivoscribe.com or contact [e-mail]

About Invivoscribe

Invivoscribe^® is a global, vertically integrated biotechnology company dedicated to Improving Lives with Precision Diagnostics^®. For over thirty years, Invivoscribe has improved the quality of healthcare worldwide by providing high-quality standardized reagents, tests, and bioinformatics tools to advance the field of precision medicine. Invivoscribe has a successful track record of partnerships with pharmaceutical companies interested in clinical trial testing via our global lab network located in the U.S., Germany, Japan, and China, and in developing and commercializing companion diagnostics, with rigorous expertise in both regulatory and laboratory services. Providing distributable kits, as well as clinical trial services through its globally located clinical lab subsidiaries, LabPMM^®, Invivoscribe is an ideal partner from diagnostic development through clinical trials, regulatory submissions, and commercialization.

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
8. Additional KMT2A partner fusion genes will be added in early 2027 further expanding ALL coverage.
9. MRD results from our KMT2A, FLT3-ITD, and NPM1 assays can be reported in as little as 48 hours, although standard turnaround time is 7-10 business days.