LeukoStrat® FLT3 Mutation Assay 2.0

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 diagnosis³. 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 Percent Agreement		Discordance #	Concordance #	*95% LL
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 Percent Agreement		Discordance #	Concordance #	*95% LL
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.

Cat. No.	Description	Amount
9-412-0091	LeukoStrat® FLT3 Mutation Assay 2.0 – ABI Fluorescence Detection	33 reactions
9-412-0101	LeukoStrat® FLT3 Mutation Assay 2.0 MegaKit – ABI Fluorescence Detection	330 reactions

If you would like more information or to receive a quote for this new LeukoStrat® FLT3 Mutation Assay 2.0, please contact our helpdesk.

Source:
Website: Invivoscribe

Related to:
Brands: Invivoscribe
Product groups: Assays