Invivoscribe, a precision diagnostics company focused on measurable residual disease (MRD) testing, has expanded its oncology portfolio with the launch of the LeukoStrat KMT2A + MRD Assay and Software. The new assay uses digital PCR technology to support screening and longitudinal MRD monitoring of KMT2A rearrangements in patients with acute myeloid leukaemia (AML), providing researchers and drug developers with a highly sensitive tool to evaluate disease burden and treatment response.

Currently available for research use in clinical trials and as a stand-alone kit for global customers, the assay will also be offered as a testing service through Invivoscribe’s LabPMM laboratory network. The platform initially targets key KMT2A rearrangements associated with AML, which represent the majority of clinically relevant fusion partners and are frequently addressed in menin-inhibitor development programs. Later this year, the assay is expected to expand to include additional rearrangements commonly found in acute lymphocytic leukaemia, broadening its application across blood cancers.

According to the company, the assay delivers detection sensitivity down to 0.005 percent, enabling identification of low-level disease signals that conventional cytogenetic or FISH testing may miss. Integrated software provides standardized, rapid analysis, allowing researchers to streamline both initial screening and ongoing MRD monitoring within a unified workflow.

Company leadership said the launch strengthens Invivoscribe’s ability to support translational research and biopharmaceutical development, particularly in programs where MRD is being explored as a surrogate endpoint. When combined with Invivoscribe’s established myeloid testing portfolio and regulatory expertise, the platform is positioned to support clinical development, companion diagnostic validation, and commercialization efforts.

Invivoscribe said the assay aligns with its broader mission to advance precision medicine through standardized diagnostics and bioinformatics tools. With a global laboratory network spanning the United States, Germany, Japan, and China, the company continues to collaborate with pharmaceutical partners to accelerate targeted therapy development and regulatory pathways in oncology.