b'TRG MRD Clonality Assay MRD TestsBackground Test Name Next-generation sequencing of the PCR products is Combinations of chemotherapy, radiation therapy andlocus become rearranged through the random deletionTRG MRD clonality assayused to identify DNA sequences specific to previously bone marrow transplantation are potentially curativeor insertion of nucleotides within the junctional region,identified clonal rearrangements detected at diagnosis. Bioinformatics tools facilitate the detection of these for several hematologic malignancies. However, in somegenerating specific and unique sequences within eachAssay Type specific sequences present at MRD levels up to 10 -6 . patients, occult tumor cells exist and are thought to increaselymphocyte. Cancer cells that arise from alterations in the patients risk of relapse. 1These subclinical levels ofsingle lymphoid precursors acquire clonal TRG junctionalNext-Generation Sequencing (NGS)The assay requires a sample taken at diagnosis as wellresidual leukemia are termed minimal residual diseaseregions which can be used as tumor-specific markers. 2,3 For Research Use Only as the post-treatment follow-up samples. If the patient has (MRD) and can be evaluated using sensitive assays. previously been tested by LabPMM for TRG clonality, no MRD detection by Next-Generation Sequencing hasThis test is performed by using the LymphoTrack Assaydiagnosic sample is needed.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).to virtually all patients. During early T-cell development,early intervention, confirmation of disease status prior toIndications for Testingthe germline variable (V), constant (C), and joining (J)transplant, and increased confidence in remission status. fragments of the T Cell Receptor Gamma (TRG)Method Descriptiondentify tumor-specific markers for post-treatment Imonitoring To track and identify previously detected TRG clonalMonitor and evaluate disease recurrencesequences in post-treatment follow-up samples, a multiplex master mix targeting the V and the J regionis used for PCR amplification.Interpretation TurnaroundSpecimenShippingStorage Time Requirements Conditions ConditionsAn interpretive5 to 14 1-3 mL of peripheral Ambient or Cool; 2-8 C up report will bebusiness daysblood in EDTA do not freezeto 7 days priorissued indicating0.25-1 mL of bone marrow (peripheral blood or to testingwhether TRG MRDin EDTA bone marrow) was detectedAmbient or frozen on 700-3500 ng of previously isolated DNA dependingdry ice (isolated DNA)References on level of sensitivity required1.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. TherAdv Hematol. 5:35-47.3.Gonzlez D et al. (2007) Immunoglobulin gene rearrangements and the pathogenesis of multiple myeloma. Blood 110:3112-21. 48 LabPMM Services Catalog 2020|49'