Companion Diagnostics (CDx)2019-08-01T22:21:27+00:00
PRODUCTS

Companion Diagnostics (CDx)

PRODUCTS

Companion Diagnostics
(CDx)

The LeukoStrat® CDx FLT3 Mutation Assay

The LeukoStrat CDx FLT3 Mutation Assay identifies mutations in the FLT3 gene, allowing physicians and healthcare providers to select the most appropriate treatment or clinical trial for their patients.

The LeukoStrat CDx Kit is a complete solution for FLT3 detection with automated software generating PDF reports inclusive of the mutant to wild type signal ratio. As the companion diagnostic to the RATIFY, ADMIRAL, and QUANTum-R Phase 3 Clinical Trials leading to the respective approvals of midostaurin (US, EU, Switzerland, Australia, South Korea), gilteritinib fumarate (US, JP), and quizartinib hydrochloride (JP), this assay is the only internationally standardized FLT3 mutation test manufactured and validated to meet international regulatory standards.

The LeukoStrat® CDx FLT3 Mutation Assay

The LeukoStrat CDx FLT3 Mutation Assay identifies mutations in the FLT3 gene, allowing physicians and healthcare providers to select the most appropriate treatment or clinical trial for their patients.

The LeukoStrat CDx Kit is a complete solution for FLT3 detection with automated software generating PDF reports inclusive of the mutant to wild type signal ratio. As the companion diagnostic to the RATIFY, ADMIRAL, and QUANTum-R Phase 3 Clinical Trials leading to the respective approvals of midostaurin (US, EU, Switzerland, Australia, South Korea), gilteritinib fumarate (US, JP), and quizartinib hydrochloride (JP), this assay is the only internationally standardized FLT3 mutation test manufactured and validated to meet international regulatory standards.
PATIENT INFORMATION

Why it Matters

The LeukoStrat CDx FLT3 Mutation Assay represents one of the most critically important biomarker tests for patients with AML.

The presence of the FLT3 mutation portends a worse outcome for survival, and some treatment regimens and targeted drug trials are only accessible to patients who test positive for the mutation. Therefore, a false negative FLT3 test result can have serious implications for the patient.
In the field of precision medicine, precise test results define treatments and accelerate drug approvals. Since FLT3 mut+ AML is both highly prognostic and clinically actionable, stratification of AML patients by testing for FLT3 mutation status may occur. For FLT3 testing, ELN Guidelines along with recent publications and clinical trials suggest the importance of test standardization for the reporting of accurate, precise or reproducible FLT3 mutant to wild type signal ratios. Meeting the need for test standardization, the LeukoStrat CDx Assays are the only global assays providing an internationally standardized signal ratio for both FLT3 ITD and TKD mutations.
TECHNICAL INFORMATION

How it Works

The LeukoStrat CDx Kit is a complete solution for FLT3 ITD and FLT3 TKD detection with automated software generating PDF reports inclusive of the mutant to wild type signal ratio.

This signal ratio has been demonstrated to provide prognostic value in both adult and pediatric AML patients. Patients with high FLT3 ITD signal ratios are likely to have less favorable outcomes.
The most prevalent and clinically significant type of FLT3 mutation is an Internal Tandem Duplication (ITD) in and around the juxtamembrane domain of the receptor. FLT3 ITD are a heterogeneous type of mutation in location, size, and number and are characterized by an aggressive phenotype with high prevalence of relapse. Clinical studies have found FLT3 ITD mutations are associated with higher numbers of leukemic cells, increased incidence of relapse, and decreased overall survival.
The second most common mutation type in the FLT3 gene is a Tyrosine Kinase Domain (TKD) point mutation in the codon for an aspartate (D835) or an isoleucine (I836) residue that is located in the activation loop of the FLT3 protein. FLT3 TKD mutations are caused by nucleic acid substitutions and/or deletions that result in a change in the amino acid sequence in this highly conserved catalytic center. TKD mutations result in constitutive autophosphorylation and activation of FLT3.
PATIENT INFORMATION

Why it Matters

The LeukoStrat CDx FLT3 Mutation Assay represents one of the most critically important biomarker tests for patients with AML.

The presence of the FLT3 mutation portends a worse outcome for survival, and some treatment regimens and targeted drug trials are only accessible to patients who test positive for the mutation. Therefore, a false negative FLT3 test result can have serious implications for the patient.
In the field of precision medicine, precise test results define treatments and accelerate drug approvals. Since FLT3 mut+ AML is both highly prognostic and clinically actionable, stratification of AML patients by testing for FLT3 mutation status may occur. For FLT3 testing, ELN Guidelines along with recent publications and clinical trials suggest the importance of test standardization for the reporting of accurate, precise or reproducible FLT3 mutant to wild type signal ratios. Meeting the need for test standardization, the LeukoStrat CDx Assays are the only global assays providing an internationally standardized signal ratio for both FLT3 ITD and TKD mutations.
TECHNICAL INFORMATION

How it Works

The LeukoStrat CDx Kit is a complete solution for FLT3 ITD and FLT3 TKD detection with automated software generating PDF reports inclusive of the mutant to wild type signal ratio.

This signal ratio has been demonstrated to provide prognostic value in both adult and pediatric AML patients. Patients with high FLT3 ITD signal ratios are likely to have less favorable outcomes.
The most prevalent and clinically significant type of FLT3 mutation is an Internal Tandem Duplication (ITD) in and around the juxtamembrane domain of the receptor. FLT3 ITD are a heterogeneous type of mutation in location, size, and number and are characterized by an aggressive phenotype with high prevalence of relapse. Clinical studies have found FLT3 ITD mutations are associated with higher numbers of leukemic cells, increased incidence of relapse, and decreased overall survival.
The second most common mutation type in the FLT3 gene is a Tyrosine Kinase Domain (TKD) point mutation in the codon for an aspartate (D835) or an isoleucine (I836) residue that is located in the activation loop of the FLT3 protein. FLT3 TKD mutations are caused by nucleic acid substitutions and/or deletions that result in a change in the amino acid sequence in this highly conserved catalytic center. TKD mutations result in constitutive autophosphorylation and activation of FLT3.