Mentype® AMLplexQS PCR Amplification Kit

Investigate gene fusions in AML diagnostics

Features

Fast decision-making in AML diagnostics in just 3 hours
Enables guideline-conform detection of 11 gene fusions in just one workflow
Reliable results through comprehensive control concept
Registered CE-IVD product

Mentype^® AMLplex^QS is the comprehensive multiplex approach for a fast detection of genetic aberrations associated with acute myeloid leukemia (AML). The assay helps to reduce hands-on time to a minimum by detecting all 11 gene fusions with a total of 34 transcript variants in a single multiplex-PCR reaction. RNA isolated from blood or bone marrow is transcribed into cDNA and subsequently amplified using the kit’s optimized components for multiplex analysis.

Biomarkers

Product Specifications

Panel
11 gene fusions, 34 transcript variants

Reactions
1 multiplex-PCR reaction per sample

Internal controls
2 (QS, ABL)

PCR controls
2 included (PC, NTC)

Sample input
1 µL cDNA from peripheral blood or bone marrow

Turnaround time
~ 3 h after nucleic acid preparation

Detection
Qualitative

To be used with
Standard thermal cycler + Thermo Fisher Genetic Analyzer

Data analysis
GeneMapper^TM ID/ ID-X + specific templates

Scientific Background

The evaluation of specific chromosomal aberrations has high prognostic value in nearly all types of acute leukemia. Molecular biological evidence of chromosomal aberrations (translocations) represents an important diagnostic completion. Detecting specific translocations enables the subtype classification of leukemic diseases and provides essential information for the risk-directed therapy of patients. According to the ELN Guidelines 2022 [1] and WHO guidelines 2016 [2] the stratification and risk categorization according to genetic abnormalities in AML is strongly recommended.

Mentype^® AMLplex^QS facilitates the detection of the most common chromosomal aberrations observed so far in AML and represents a simple-to-use, routine-fit, and reliable screening tool.

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)
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)

Product References

Kunadt, D. et al. Impact of KMT2A-PTD Mutational Subgroups on Outcome of AML Patients after Induction Therapy and Allogeneic Hematopoietic Cell Transplantation. Blood 142, 2236. https://doi.org/10.1182/blood-2023-187273 (2023)
Stölzel, F. et al. A new multiplex PCR tool enables timely identification of actionable targets for molecular-guided therapy in patients with acute myeloid leukemia, HemaSphere 7; https://doi.org/10.1097/01.HS9.0000969132.52844.57 (2023)
Stasik, S. et al. Point Mutations in the FLT3-ITD Region Are Rare but Recurrent Alterations in Adult AML and Associated With Concomitant KMT2A-PTD, Front. Oncol. 12, https://doi.org/10.3389/fonc.2022.862991 (2022)
Frech, M. et al. The Genes for Tissue Factor F3 and Nuclear Receptor 4A Are Down-Regulated in Early Death Acute Promyelocytic Leukemia Patients. Blood 132, 3902; https://doi.org/10.1182/blood-2018-99-112978 (2018)
Haferlach, T. et al. Robustness of comprehensive DNA- and RNA-based assays at diagnosis of acute myeloid leukemia using blood and bone marrow stored on filter cards. Leukemia 30, 2123-2125; https://doi.org/10.1038/leu.2016.156 (2016)