LeukoStrat CDx FLT3 Mutation Assay
Companion Diagnostic
LeukoStrat CDx FLT3 Mutation Assay is an FDA-approved companion diagnostic used to help identify patients who may be eligible for targeted therapies.
Use
The LeukoStrat CDx FLT3 Mutation Assay is intended to assist physicians in making treatment decisions for their AML patients with FLT3 mutations. It is a companion diagnostic for midostaurin (US), gilteritinib fumarate (US, Japan, EU, Switzerland), and quizartinib hydrochloride (US, Japan, EU). The test is used to detect genetic mutations in the FLT3 gene, which are important driver mutations in AML. The presence of these mutations signifies a poor prognosis, necessitating accurate testing for better treatment outcomes.
Special Instructions
FLT3 testing is recommended for newly diagnosed AML patients, and FLT3 mutation status may change with relapse/refractory AML. This makes ongoing testing essential for informed treatment decisions. Utilize the LeukoStrat CDx FLT3 Mutation Assay for a globally standardized testing approach.
Limitations
A false negative FLT3 test result can have serious implications for the patient as some treatment regimens and targeted drug trials are accessible only to patients who test positive for the mutation. Accurate testing is critical to avoid misdiagnosis and ensure appropriate treatment.
FDA ApprovedCompanion Diagnostic
Methodology
PCR-based (PCR)
Biomarkers
Result Turnaround Time
Not provided.
Related Documents
For more information, please review the documents below
Not provided.