Invivoscribe® Launches LeukoStrat® KMT2A + MRD Assay to Advance High-Sensitivity Leukemia Testing in Clinical Trials and Patient Management Worldwide

SAN DIEGO--(BUSINESS WIRE)--Invivoscribe, a leader in precision medicine and measurable residual disease (MRD) testing, today announced the addition of the LeukoStrat^® KMT2A + MRD Assay and Software to its industry-leading oncology portfolio. The assay leverages digital PCR (dPCR) to support both screening and precise longitudinal MRD monitoring for KMT2A rearrangements in acute myeloid leukemia (AML) subjects. This quantitative test is currently available for research use in clinical trials and as a stand-alone kit for purchase by our global customers, and will soon be available as a service in our regional LabPMM^® laboratories worldwide.

The assay is available to detect key AML-associated KMT2A rearrangements, which account for the vast majority of KMT2A fusion partners in AML¹ and those most commonly targeted in menin-inhibitor clinical development programs. Later this year, the assay will be enhanced with four additional KMT2A rearrangements which are frequently found in acute lymphocytic leukemia (ALL), expanding its utility across leukemias.

The LeukoStrat KMT2A + MRD Assay accurately identifies and quantifies common KMT2A rearrangements that drive KMT2A-translocated acute leukemias, offering translational researchers and biopharmaceutical partners a critical tool to assess MRD and to evaluate therapeutic response. With unprecedented sensitivity down to 0.005% (5x10^-5) and precise quantitation through normalization against a control gene, the assay enables far more rapid turnaround time and more sensitive detection of low-level KMT2A rearrangements that traditional cytogenetics and FISH methods miss. The LeukoStrat^® KMT2A + MRD Assay and Software streamline both initial screening and longitudinal MRD monitoring from a single workflow, facilitating efficient implementation both in research laboratories and as a service supporting clinical research.

"Invivoscribe is setting a new standard for how researchers and biopharmaceutical partners can identify, monitor and understand disease response," said Jeff Miller, CEO and CSO at Invivoscribe. "Our LeukoStrat KMT2A + MRD Assay provides partners with a powerful tool for exploratory and pivotal analyses in menin-inhibitor trials, offering precise insights into subject response throughout treatment. This assay builds on our international reputation as the ideal partner for pharmaceuticals looking to accelerate KMT2A trials using MRD as a surrogate endpoint and for companion diagnostic development as these therapies advance toward approval."

The assay integrates with LeukoStrat^® KMT2A + MRD Software for rapid, objective analysis, enabling labs and biopharmaceutical partners to unlock complex molecular insights. When paired with Invivoscribe's globally standardized LabPMM^® network and regulatory expertise, it supports the full development pathway from early-phase trials through CDx validation and commercialization.

For a comprehensive approach to therapy development, biopharmaceutical partners can combine the LeukoStrat KMT2A + MRD Assay for treatment monitoring with Invivoscribe's established myeloid portfolio of IVDR and research use only LeukoStrat CDx and MRD assays, including prognostic biomarkers such as FLT3 and NPM1.^2,3,4,5 Invivoscribe's proven track record in companion diagnostics (CDx) development and successful global regulatory submissions positions the company as a trusted strategic partner for menin-inhibitor programs progressing toward approval.

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 our 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. For more information, please visit www.invivoscribe.com, contact [e-mail], or follow Invivoscribe on LinkedIn.

References

1. Meyer, C., et al. Leukemia 2023; 37, 988–1005. DOI: 10.1038/s41375-023-01877-1
2. Dillon, L. et al. JAMA. 2023; 329(9):745-755. DOI: 10.1001/jama.2023.1363
3. Dillon, L. et al. JAMA Oncology. 2024; 10(8)1104-1110. DOI: 10.1001/jamaoncol.2024.0985
4. Levis, M. et al. Blood. 2025; 145(19):2138-2148. DOI: 10.1182/blood.2024025154
5. Al-Ali, R. et al. Bone Marrow Transplantation. 2025; DOI: 10.1038/s41409-025-02757-1