The LeukoStrat®
FLT3 Mutation Assay 2.0 is an
in vitro diagnostic product intended for PCR-based detection of FLT3 activating mutations in patients with acute myelogenous leukemia (AML). Specifically, the
FLT3 Mutation Assay 2.0 can be used to:
- Identify internal tandem duplications (ITD) in the FLT3 gene.
- Identify tyrosine kinase domain (TKD) mutations in the FLT3 gene.
Summary
AML in general has a poor prognosis
1,2. Assessment of the mutation status of the
FLT3 (fms related tyrosine kinase 3) receptor gene is the most important prognostic indicator of disease outcome, occurring in approximately 30% of patients at the time of diagnosis
3. For this reason, testing for
FLT3 activating mutations is required for the stratification of disease and determination of appropriate treatment options. The LeukoStrat®
FLT3 Mutation Assay 2.0 is a PCR-based method that identifies internal tandem duplication (ITD) mutations and tyrosine kinase domain (TKD) mutations.
This test kit includes 2 master mixes: the
FLT3-ITD Master Mix for the detection of ITD mutations and
FLT3-D835 Master Mix for the detection of TKD region mutations (such as the D835 and I836 mutations).
Performance Characteristics
The LeukoStrat®
FLT3 Mutation Assay 2.0 is a rapid and reliable method for the detection of
FLT3 mutations, as evidenced by comparison with Roche® 454 sequencing.
The
FLT3 Mutation Assay 2.0 is capable of detecting
FLT3-ITD and TKD mutations with an excellent concordance (Table 1 and 2) and has high reliability when multiple standard laboratory variables are considered including multiple operators, reagent lots, different ABI 3500xL instruments, and nonconsecutive testing days.
Table 1. FLT3 ITD Percent Agreement 454 Sequencing
Negative PA
| 100%
| 0 | 119 | 96.9% |
Positive PA
| 98.0%
| 4
| 200 | 95.1% |
*95% of results would be expected to agree with sequencing at a rate greater than or equal to the lower limit (LL).
Table 2. FLT3 TKD Percent Agreement with 454 Sequencing
Negative PA
| 100% | 0
| 137 | 96.9% |
Positive PA
| 100% | 0 | 240 | 98.5% |
*95% of results would be expected to agree with sequencing at a rate greater than or equal to the lower limit (LL).
References
- Murphy, KM. et al., (2003). Detection of FLT3 Internal Tandem Duplication and D835 Mutations by a Multiplex Polymerase Chain Reaction and Capillary Electrophoresis Assay. The Journal of Molecular Diagnostics 5, 96 – 102.
- Yamamoto, Y. et al., (2001). Activating mutation of D835 within the activation loop of FLT3 in human hematologic malignancies. Blood 97, 2434-2439.
- Acute Myeloid Leukemia, Clinical Practice Guidelines in Oncology, (v.2.2014) National Comprehensive Cancer Network.
If you would like more information or to receive a quote for this new LeukoStrat® FLT3 Mutation Assay 2.0, please contact our
helpdesk.
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