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The TRUPCR® Acute Leukemia Panel Kit is an in vitro Real-Time PCR assay intended for the qualitative detection of diagnostic and prognostic markers associated with acute myelogenous leukemia (AML) and acute lymphoblastic leukemia (ALL) in peripheral blood samples. The assay enables comprehensive molecular profiling through the detection of clinically relevant fusion transcripts and gene mutations involved in leukemogenesis, supporting diagnosis, risk stratification, prognosis, and therapeutic decision-making.
The panel detects a broad range of leukemia-associated biomarkers, including fusion genes such as PML-RARA, AML1-ETO (RUNX1-RUNX1T1), CBFB-MYH11, BCR-ABL1 (p190, p210, p230), E2A-PBX1 (TCF3-PBX1), TEL-AML1 (ETV6-RUNX1), MLL rearrangements (MLL-AF4, MLL-ENL, MLL-AF9, MLL-AF6, MLL-AF10), DEK-CAN, SET-CAN, and RBM15-MKL1. In addition, the kit identifies key DNA mutations including FLT3-TKD, FLT3-ITD, NPM1, C-KIT, IDH1, and IDH2 variants.
The assay combines reverse transcription real-time PCR for RNA fusion transcript detection with allele-specific ARMS PCR and conventional PCR methods for DNA mutation analysis, enabling sensitive and specific detection of both Class I and Class II leukemia-associated alterations.
The kit includes reagents for reverse transcription, amplification, mutation detection, controls, and analysis, and is compatible with multiple major Real-Time PCR platforms, including Applied Biosystems™ 7500 Series, QuantStudio® 3 and 5, Rotor-Gene Q, Bio-Rad CFX96/CFX384, and Agilent AriaMx systems.
Designed for routine molecular diagnostics, the TRUPCR® Acute Leukemia Panel Kit offers a rapid, reliable, comprehensive, and cost-effective workflow for leukemia testing in clinical laboratories.
The TRUPCR® Acute Leukemia Panel Kit is a multiplex in vitro diagnostic assay designed for the qualitative detection of clinically significant genetic markers associated with acute myelogenous leukemia (AML) and acute lymphoblastic leukemia (ALL). Using Real-Time PCR, reverse transcription PCR, ARMS PCR, and conventional PCR methodologies, the panel enables comprehensive molecular characterization of leukemia-associated fusion transcripts and gene mutations from peripheral blood samples.
The assay detects a broad spectrum of clinically relevant biomarkers involved in leukemogenesis, disease classification, prognosis, and therapeutic decision-making. Detectable fusion transcripts include PML-RARA, AML1-ETO (RUNX1-RUNX1T1), CBFB-MYH11, BCR-ABL1 (p190, p210, p230), E2A-PBX1 (TCF3-PBX1), TEL-AML1 (ETV6-RUNX1), MLL rearrangements (MLL-AF4, MLL-ENL, MLL-AF9, MLL-AF6, MLL-AF10), DEK-CAN, SET-CAN, and RBM15-MKL1. The panel additionally identifies important DNA mutations including FLT3-TKD, FLT3-ITD, NPM1, C-KIT, IDH1, and IDH2 variants.
Each target is amplified using optimized primer and probe chemistry to provide high specificity and sensitivity. Internal control genes, including ABL1 and reference controls, are incorporated to monitor RNA quality, DNA integrity, and assay performance, enabling reliable interpretation of results.
This consolidated workflow minimizes the need for multiple standalone assays, supporting efficient, high-throughput leukemia testing with rapid turnaround times and reduced hands-on processing.
Acute leukemias are hematological malignancies characterized by the uncontrolled proliferation of immature blood cell precursors, resulting in impaired normal hematopoiesis. Acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL) are genetically heterogeneous diseases driven by chromosomal rearrangements, fusion genes, and somatic mutations that influence disease progression, prognosis, and treatment response.
In AML, leukemogenesis is commonly associated with two major classes of genetic alterations. Class I mutations, including FLT3, C-KIT, and IDH1/2 mutations, promote abnormal cell proliferation and survival. Class II alterations, such as PML-RARA, AML1-ETO, CBFB-MYH11, and NPM1 mutations, disrupt cellular differentiation and apoptosis pathways. In ALL, recurrent chromosomal translocations and fusion transcripts including BCR-ABL1, E2A-PBX1, TEL-AML1, and MLL rearrangements play critical roles in disease pathogenesis and clinical outcome.
The TRUPCR® Acute Leukemia Panel Kit enables simultaneous detection of these clinically relevant molecular abnormalities, supporting comprehensive profiling of AML and ALL subtypes for diagnostic, prognostic, and therapeutic applications.
The TRUPCR® Acute Leukemia Panel Kit provides sensitive and reliable detection of leukemia-associated fusion transcripts and mutations within a streamlined workflow suitable for routine molecular diagnostics laboratories.
The assay supports:
The kit is optimized for rapid and efficient processing while maintaining robust analytical performance for both RNA- and DNA-based targets.
Assay Type:
Multiplex qualitative Real-Time PCR, Reverse Transcription PCR, ARMS PCR, and Conventional PCR
Target Analytes:
Control Genes:
ABL1 endogenous RNA control and reference DNA controls
Sample Type:
Peripheral blood
Compatible Platforms:
Product Catalogus
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