Interpretation Turn-around Time Specimen Requirements Shipping Conditions Storage Conditions An interpretive report will be issued indicating whether FLT3 ITD MRD was detected 7 to 10 business days •  3 mL of peripheral blood in EDTA •  1 mL of bone marrow in EDTA •  1 µg of previously isolated DNA  Ambient or Cool;  Do not freeze • Room Temp up to 72 hours •  2-8 °C up to 7 days Test Name FLT3 ITD MRD assay Assay Type Next-Generation Sequencing (NGS) CLIA validated assay Method Description To track and identify previously detected FLT3 ITD mutations in post treatment follow up samples, a multiplex master mix targeting the juxtamembrane domain of the FLT3 gene is used to amplify DNA extracted from a patient sample. Next-generation sequencing of the PCR products is used to identify DNA sequences specific to previously identified mutations detected at diagnosis. Bioinformatics tools facilitate the detection of these specific sequences present at an allelic sensitivity level of 5x10-5 . Indications for Testing •  Identify tumor-specific markers for post-treatment monitoring • Monitor and evaluate disease recurrence MRD Tests LabPMM Services Catalog 2019 | 43 Clinical Information Minimal residual disease (MRD) detection in patients with leukemia has proven to be useful in the clinical management of disease and can facilitate the development of new therapies. Mutations in the fms related tyrosine kinase 3 (FLT3) gene are the most prevalent mutations found in acute myeloid leukemia (AML)1 and are characterized by an aggressive phenotype with a high prevalence of relapse. Internal tandem duplication (ITD) mutations within the juxtamembrane domain are the most common mutations of FLT3 2 . The development of a sensitive and specific assay for FLT3 ITD mutations represents a significant advancement in guiding treatment decisions. LabPMM’s FLT3 ITD MRD test is an NGS-based targeted deep sequencing assay that detects ITDs ranging from 3 bp to over 200 bp in size. Once a specific ITD (length and sequence) has been identified in a primary sample, it can easily be tracked in subsequent samples at a sensitivity of 5x10-5 , provided sufficient DNA quantity is tested. MRD detection by Next-Generation Sequencing has demonstrated utility in predicting clinical outcomes and in generating clinically actionable results – allowing early intervention, confirmation of disease status prior to transplant, and increased confidence in remission status. The treatment of AML has become a paradigm for precision medicine. This MRD assay is at least two orders of magnitude more sensitive than other commercially available FLT3 assays. It detects the persistence of a driver mutation, FLT3 ITD, in patients with no overt evidence of disease, allowing us to identify those patients that can benefit from continuation or modification of treatment3 . AML - FLT3 ITD MRD Assay References 1.  The Cancer Genome Atlas Research Network (2013) Genomic and Epigenomic Landscapes of Adult De Novo Acute Myeloid Leukemia. N Engl J Med. 368: 2059–2074. 2. Konig H. et al. (2015) Targeting FLT3 to treat leukemia. Expert Opin Ther Targets 19:37-54. 3.  Levis, M. J. et al (2018) A next-generation sequencing–based assay for minimal residual disease assessment in AML patients with FLT3-ITD mutations. Blood Advances, 2: 825-831 42