Invivoscribe has launched the LeukoStrat® KMT2A + MRD Assay and Software, expanding its oncology portfolio with a high-sensitivity molecular test designed to support leukemia research, clinical trials, and patient monitoring.
The new assay uses digital PCR (dPCR) technology to enable both initial screening and precise longitudinal monitoring of measurable residual disease (MRD) in patients with KMT2A-rearranged acute myeloid leukemia (AML).
The quantitative assay is currently available for research use in clinical trials and as a stand-alone kit for global customers. It will also be offered as a testing service through Invivoscribe’s regional LabPMM® laboratories worldwide in the near future.
The assay detects the most common AML-associated KMT2A rearrangements, which account for the majority of KMT2A fusion partners and are widely targeted in menin-inhibitor drug development programs. Later in 2026, the test will be expanded to include four additional KMT2A rearrangements frequently observed in acute lymphocytic leukemia (ALL), extending its application across multiple leukemia subtypes.
Designed for translational research and biopharmaceutical development, the LeukoStrat KMT2A + MRD Assay enables accurate quantification of disease burden with sensitivity as low as 0.005 percent. By normalizing results against a control gene, the assay allows for precise measurement of low-level KMT2A rearrangements that may not be detected using conventional cytogenetics or fluorescence in situ hybridization (FISH) methods. The integrated workflow supports both baseline screening and ongoing MRD assessment, reducing turnaround time and improving efficiency in research and clinical trial settings.
The assay is paired with LeukoStrat® KMT2A + MRD Software, which provides rapid and standardized data analysis. When combined with Invivoscribe’s globally harmonized LabPMM® laboratory network and regulatory expertise, the platform supports biomarker development from early-phase research through companion diagnostic validation and commercialization.
Biopharmaceutical developers can integrate the new assay with Invivoscribe’s broader myeloid testing portfolio, which includes IVDR and research-use LeukoStrat CDx and MRD assays for established biomarkers such as FLT3 and NPM1.
Invivoscribe’s experience in companion diagnostic development and global regulatory submissions positions the company as a key partner for menin-inhibitor programs advancing toward regulatory approval.
