An interpretive report will be issued indicating whether NPM1 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 NPM1 MRD assay Assay Type Next-Generation Sequencing (NGS) CLIA validated assay Method Description To track and identify previously detected NPM1 mutations in post treatment follow up samples, a multiplex master mix targeting exon 12 on the NPM1 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 Interpretation Turn-around Time Specimen Requirements Shipping Conditions Storage Conditions MRD Tests LabPMM Services Catalog 2019 | 45 Clinical Information Minimal residual disease (MRD) detection in patients with leukemia is useful for the clinical management of disease, and can facilitate the development of new therapies. Mutations in the nucleophosmin (NPM1) gene represent some of the most prevalent gene mutations in AML1 . NPM1 mutations predominantly occur in AML with normal cytogenetics and are of prognostic value, especially within the context of FLT3 ITD mutations. Furthermore, because NPM1 displays a homogeneous mutation pattern, this gene represents an attractive target for MRD monitoring2 . LabPMM’s NPM1 MRD test is a NGS-based targeted deep sequencing assay that can be used to sensitively detect NPM1 mutations that were previously identified in a primary sample. 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. AML - NPM1 MRD Assay References 1.  Falini B. et al. (2005) Cytoplasmic nucleophosmin in acute myelogenous leukemia with a normal karyotype. N Engl J Med 352:254–266. 2.  Krönke J. et al. (2011) Monitoring of minimal residual disease in NPM1-mutated acute myeloid leukemia: a study from the German-Austrian acute myeloid leukemia study group. J Clin Oncol 29:2709-2716. 44