Invivoscribe, a leader in precision medicine and measurable residual disease testing, has announced the launch of the LeukoStrat KMT2A + MRD Assay and Software, expanding its oncology portfolio. The assay uses digital PCR to support both screening and precise longitudinal monitoring of KMT2A rearrangements in acute myeloid leukemia patients. Currently available for research use in clinical trials and as a stand-alone kit for global customers, the assay will soon also be offered as a service through Invivoscribe’s LabPMM laboratories worldwide.
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This assay detects key AML-associated KMT2A rearrangements, which represent most KMT2A fusion partners in AML and are commonly targeted in menin-inhibitor clinical programs. Later this year, the assay will be expanded to detect four additional KMT2A rearrangements frequently seen in acute lymphocytic leukemia, broadening its clinical utility. The LeukoStrat KMT2A + MRD Assay provides sensitive and accurate quantitation of common KMT2A rearrangements that drive KMT2A-translocated leukemias, giving researchers and biopharmaceutical partners a powerful tool to monitor measurable residual disease and assess therapeutic response. With sensitivity down to 0.005 percent and precise normalization against a control gene, it allows detection of low-level rearrangements that standard cytogenetic and FISH methods often miss. The assay streamlines both initial screening and longitudinal monitoring in a single workflow, making it suitable for research labs and clinical trial services.
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Jeff Miller, CEO and CSO at Invivoscribe, stated that the company is setting a new standard for monitoring disease and understanding therapeutic response. He explained that the LeukoStrat KMT2A + MRD Assay offers partners a highly sensitive tool for exploratory and pivotal analyses in menin-inhibitor trials. It also reinforces Invivoscribe’s reputation as a strategic partner for pharmaceutical companies seeking to accelerate KMT2A trials using MRD as a surrogate endpoint and to support companion diagnostic development.
The assay is paired with LeukoStrat KMT2A + MRD Software for rapid, objective analysis, helping labs and partners extract detailed molecular insights. Combined with Invivoscribe’s globally standardized LabPMM network and regulatory expertise, the assay supports development from early-phase trials through companion diagnostic validation and commercialization. Researchers can integrate it with Invivoscribe’s myeloid portfolio of LeukoStrat CDx and MRD assays, including prognostic biomarkers such as FLT3 and NPM1, providing a comprehensive solution for therapy monitoring and drug development.
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