b'IGK MRD Clonality Assay MRD TestsBackground Test Name used to identify DNA sequences specific to previously Combinations of chemotherapy, radiation therapy and bonerearranged through the random deletion or insertion ofIGK MRD clonality assayidentified clonal rearrangements detected at diagnosis. Bioinformatics tools facilitate the detection of these specific marrow transplantation are potentially curative for severalnucleotides within the junctional region, generating specificsequences present at MRD levels up to 10 -6 . hematologic malignancies. However, in some patients, occultand unique sequences within each lymphocyte. Cancer cellsAssay Typetumor cells exist and are thought to increase the patientsthat arise from alterations in single lymphoid precursorsThe assay requires a sample taken at diagnosis as wellrisk of relapse. 1These subclinical levels of residual leukemiaacquire clonal IGK junctional regions which can be used asNext-Generation Sequencing (NGS)as the post-treatment follow-up samples. If the patientare known as minimal residual disease (MRD), and can betumor-specific markers. 2-3 For Research Use Only has previously been tested by LabPMM for IGK clonality,evaluated using sensitive assays. This test is performed by using the LymphoTrack Assayno diagnosic sample is needed. MRD detection by Next-Generation Sequencing has The tracking of antigen-receptor gene rearrangementsdemonstrated utility in predicting clinical outcomesfrom Invivoscribe. Data is analyzed using the LymphoTrack for clonality analyses and MRD monitoring can be appliedand in generating clinically actionable results, allowingMRD Data Analysis Tool (RUO). Indications for Testingto virtually all patients. During early B-cell development,early intervention, confirmation of disease status prior toIdentify tumor-specific markers forthe germline variable (V), constant (C), and joining (J)transplant, and increased confidence in remission status.Method Description post-treatment monitoring fragments of the immunoglobulin kappa (IGK) locus become To track and identify previously detected IGK clonalMonitor and evaluate disease recurrencesequences in post-treatment follow-up samples, a multiplex master mix targeting the conserved V, J, C and kappa deleting element (K de ) regions is used for PCR amplification. Next-generation sequencing of the PCR products is Interpretation TurnaroundSpecimenShippingStorage Time Requirements Conditions ConditionsAn interpretive5 to 14 1-3 mL of peripheral Ambient or Cool; 2-8 C up report will bebusiness days blood in EDTA do not freezeto 7 days priorissued indicating0.25-1 mL of bone marrow (peripheral blood orto testingwhether IGK MRDin EDTAbone marrow) was detected700-3500 ng of previouslyAmbient or frozen onisolated DNA dependingdry ice (isolated DNA) on level of sensitivity requiredReferences1.Rezuke WN et al. (1997) Molecular diagnosis of B- and T-cell lymphomas: fundamental principles and clinical applications. Clin Chem 43:1814-23.2.Gazzola A et al. (2014) The evolution of clonality testing in the diagnosis and monitoring of hematological malignancies. Ther Adv Hematol. 5:35-47.3.Gonzlez D et al. (2007) Immunoglobulin gene rearrangements and the pathogenesis of multiple myeloma. Blood 110:3112-21. 44 LabPMM Services Catalog 2020|45'