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The TRUPCR® Leukemia Fusion Gene Panel Kit is a CE-IVD certified, real-time PCR-based diagnostic solution designed for the qualitative detection of key fusion gene transcripts associated with acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). This comprehensive assay enables simultaneous identification of multiple clinically relevant fusion markers in a single workflow, streamlining molecular diagnosis and risk stratification.
Targeting over 20 distinct transcript variants, the kit covers fusion genes including PML-RARA (bcr1, bcr2, bcr3), BCR-ABL1 (p190, p210, p230), AML1-ETO (RUNX1-RUNX1T1), CBFB-MYH11, and various MLL rearrangements (e.g., MLL-AF4, MLL-ENL, MLL-AF9). The panel supports differential diagnosis and subtyping of AML and ALL cases, playing a vital role in treatment decisions and minimal residual disease (MRD) monitoring.
The test is based on a robust two-step RT-PCR process using total RNA from bone marrow or peripheral blood, with amplification verified through an ABL1 internal control to ensure RNA quality and assay integrity. With a detection limit as low as 10 copies, this assay offers excellent sensitivity and reliability. Compatible with widely used PCR platforms, it is an ideal solution for routine molecular diagnostic labs seeking speed, precision, and broad leukemia gene fusion coverage.
The TRUPCR® Leukemia Fusion Gene Panel Kit is a real-time PCR-based in vitro diagnostic assay designed for the qualitative detection of key diagnostic and prognostic fusion gene markers in patients with acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). This CE-IVD certified assay enables the identification of multiple clinically relevant gene fusions—including PML-RARA, BCR-ABL1, AML1-ETO, MLL rearrangements, and more—using total RNA extracted from peripheral blood or bone marrow. It uses a two-step RT-PCR protocol with specific primers and fluorescent probes, alongside an internal ABL1 control for RNA integrity and quantification.
Leukemias are hematologic malignancies marked by uncontrolled proliferation of abnormal white blood cells, interrupting normal hematopoiesis. AML and ALL represent the acute subtypes of these diseases, with rapid progression and high mortality if left untreated. Accurate and early molecular characterization is essential for diagnosis, risk stratification, treatment planning, and measurable residual disease (MRD) monitoring.
Many leukemia subtypes are defined by fusion genes resulting from chromosomal rearrangements—such as t(15;17) in APL or t(8;21) in AML. These leukemia fusions act as oncogenic drivers and serve as critical diagnostic markers.
The TRUPCR® Leukemia Fusion Gene Panel Kit delivers high sensitivity (LOD: 10 copies) and specificity across a broad fusion target panel. The assay supports:
It is optimized for ease of use and consistent results across major qPCR platforms.
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