Leukemia FusionOne Panel Kit

A novel multiplex and non-NGS system for simultaneously detecting 52 genes, including fused and mutant variants in leukemia patients.

Many hematologic malignancies carry characteristic chromosomal translocations. Correct identification of fusion genes can ensure an accurate diagnosis and prognosis is made and can assist in making treatment decisions, stratification, and disease monitoring. Current methodologies used to detect fusion genes can be laborious and time-consuming, typically involving karyotyping, followed by fluorescence in situ hybridization (FISH) and molecular analysis based on reverse transcriptase polymerase chain reaction (RT-PCR).

Leukemia FusionOne Panel Kit is a qualitative in vitro diagnostic test for screening 52 fusion genes resulting from chromosome translocations involved in chronic and acute leukemia and leukemia-associated genes EVI1, HOX11, and HOX11L2.

All 52 genes include more than 182 clinically relevant chromosomal breakpoints. The kit detects RNA transcripts of the 52 leukemia-associated genes extracted from human bone marrow or whole blood samples using a RT-qPCR procedure. The kit results allow professionals to be more aware of the patient`s prognosis and provide professionals with essential insights into treatment planning.

 

Key Features:

  • Multiplexing: Allows simultaneous detection of 52 gene variants.
  • Comprehensiveness: The follow-up quantification kits are available to detect the corresponding variants for MRD monitoring.
  • Compatibility: Compatible with most current real-time qPCR instruments.
  • Rapid: Results can be obtained in 2-3 hours.
  • Simple: Easy to perform for routine screening.
  • Cost Effective: Can be performed for a fraction of the cost of NGS.

Advantages when compared with NGS:

  • Cost-Effectiveness:
    • Significantly more affordable than NGS solutions;
    • Reduces the need for expensive sequencing equipment and bioinformatics expertise.
  • Simplicity and Speed:
    • Rapid Results: Complete detection within 3 hours, ideal for urgent clinical decision-making.
    • Ease of Use: Requires only standard RT-qPCR instruments (e.g., ABI7500, CFX96) without complex library preparation or data interpretation.
    • Minimal training required for implementation.
  • Comprehensive Coverage:
    • Detects 52 clinically significant fusion genes, including rare subtypes and key genes such as BCR-ABL1 (p190, p210) and PML-RARA (L, S, V).
    • Covers more than 182 chromosomal breakpoints relevant to leukemia.
  • Integrated Monitoring Solution:
    • Offers quantitative assays for each fusion gene detected, enabling precise treatment monitoring and MRD evaluation (Not included in this kit).
    • Provides actionable data for personalized therapy adjustments.
  • Clinical Utility:
    • Tailored specifically for leukemia diagnostics, avoiding irrelevant genomic data often generated by NGS.
    • Supports therapy decisions, including targeted treatments (e.g., tyrosine kinase inhibitors for BCR-ABL1-positive patients).

Disease Relevance:

  • AML, ALL, CML, CLL.

 

Technical Specs:

Genes 52 genes:

MLL-AF9, AML1-ETO, MLL-AF4, TEL-AML1, E2A-PBX1, MLL-ENL, SIL-TAL1, MLL-AF10, CBFβ-MYH11, AML1-MDS1/EV11,

FIP1L1-PDGFRA, SET-CAN, E2A-HLF, DEK-CAN, MLL-SEPT6, TLS-ERG, TEL-PDGFRB, MLL-ELL, MLL-AF17, NPM-RARα,

NPM-MLF1, PLZF-RARα, MLL-AF1q, MLL-AF1P, TEL-ABL1, AML1-MTG16, AML1-EAP, MLL-AF6, EVI1, BCR-ABL1 p190,

BCR-ABL1 p210, PML-RARα S, PML-RARα V, PML-RARα L, CALM-AF10, HOX11, TEL-JAK2, MLL-AFX1, ETV6-PDFGRA, HOX11L2,

dup MLL, NUP98-PMX1, NUP98-HOXD13, NUP98-HOXA9, NUP98-HOXA13, NUP98-HOXC11, NUP98-HOXA11, STAT5-RARα,

NUMA-RARα, FIPIL1-RARα, PRKAR1A-RARα, NPM-ALK.

Sample types Bone marrow, peripheral blood, FFPE, and cell lines
Reaction Volume 20 ul
Reaction time 3 hour
Internal control GUSB as housekeeping genes, 2 positive control, 3 negative control
Sensitivity 10-4
Instruments Compatible with Bio-Rad CFX96, iCycler, ABI7500, Stratagene Mx3000P/Mx3005P, and other commonly used RT-qPCR machines.

 

Ordering Information:

Cat. No. Description Size
1-100-12020 Leukemia FusionOne Panel Kit 20-reactions

 

The Leukemia FusionOne Panel Kit is a CE-marked product for In Vitro Diagnostic Use.
The Leukemia FusionOne Panel Kit is not FDA-cleared.

 

Looking for a tailored solution to meet your research or clinical needs?

The FusionOne Panel offers customization options to ensure it perfectly aligns with your specific requirements.

  • Add Genes of Interest: Expand the panel by including additional fusion genes relevant to your studies or clinical trials.
  • Tailored Design: Work with our team to develop a fully customized panel that addresses unique research or diagnostic challenges.
  • Seamless Integration: All custom designs maintain the high sensitivity, specificity, and rapid turnaround time of the standard FusionOne Panel.

Whether you need to focus on a niche genetic signature or broaden the panel’s capabilities, our customization options provide the flexibility you need without sacrificing performance or affordability.

A customized FusionOne Panel provides the perfect balance of precision, efficiency, and flexibility, tailored to meet the demands of your unique research or clinical goals. Its ability to adapt to evolving scientific needs ensures that it remains a valuable tool for laboratories, pharmaceutical companies, and healthcare institutions alike.

Contact us today to discuss your requirements and create the perfect solution for your needs!

Contact Us  :    1-855-QuanDx-Care (1-855-782-6392)   OR   650-262-4140       info@quandx.com     Product Inquiry
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