Mentype® AMLplus Mutation Analysis Kit

Features

• Fast, actionable results for AML-associated mutation analysis in just 4 hours
• Qualitative screening of five hotspot regions and multiple mutation variants
• Streamlined workflow, detecting all targets in a single multiplex assay
• Reliable performance, supported by a thorough control concept

Mentype^® AMLplus Mutation Analysis Kit is a comprehensive multiplex PCR assay for detecting mutations associated with acute myeloid leukemia (AML). Using genomic DNA from peripheral blood or bone marrow, the assay simultaneously amplifies five target genes across multiple variants. Fluorophore-labeled amplicons are separated by fragment length on the Genetic Analyzer series from Thermo Fisher Scientific. The kit includes Mentype^® AMLplus Profiler software for standardized data evaluation, further supporting efficient and reliable mutation analysis for research applications.

Biomarkers

5 genetic hotspots: NPM1 (wildtype and insertions), FLT3 (TKD mutations, ITD and wildtype ), IDH1 (R132X mutations), IDH2 (R140X and R172X mutations), CEBPA (bZIP wildtype, insertions and deletions)

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Scientific Background

Acute myeloid leukemia (AML) is a biologically heterogeneous disorder of the hematopoietic system. AML-associated samples exhibit a wide spectrum of genetic alterations affecting pathways involved in cell proliferation, differentiation, and metabolism. Identification and analysis of such alterations have therefore become central to research efforts aimed at understanding disease mechanisms and supporting the development of targeted therapeutic approaches.

In clinical practice, molecular profiling plays a key role in the diagnostics of AML. According to the European LeukemiaNet and the World Health Organization guidelines, assessment of genetic aberrations is required for disease classification, risk stratification, and therapy selection [1,2]. Given the aggressive nature of AML, timely characterization of selected mutations and gene fusions is critical, placing high demands on the methods used for molecular profiling with respect to reliability and turnaround time.

1. Döhner, H. et al. Diagnosis and management of AML in adults: 2022 recommendations from an international expert panel on behalf of the ELN. Blood 140, 1345-1377; https://doi.org/10.1182/blood.2022016867 (2022)
2. Arber, D. et al. The 2016 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia. Blood 127, 2391-2405; https://doi.org/10.1182/blood-2016-03-643544 (2016)