b'TRB MRD Clonality Assay MRD TestsBackground Test Name detected at diagnosis. Bioinformatics tools facilitate the detection of these specific sequences present at MRD Combinations of chemotherapy, radiation therapy andnucleotides within the junctional region, generatingTRB MRD clonality assaylevels up to 10 -6 . bone marrow transplantation are potentially curativespecific and unique sequences within each lymphocyte. for several hematologic malignancies. However, in someCancer cells that arise from alterations in single lymphoidAssay Type The assay requires a sample taken at diagnosis as wellpatients, occult tumor cells exist and are thought to increaseprecursors acquire clonal TRB junctional regions which canas the post-treatment follow-up samples. If the patient has the patients risk of relapse. 1These subclinical levels ofbe used as tumor-specific markers. 2,3 Next-Generation Sequencing (NGS)previously been tested by LabPMM for TRB clonality, no residual leukemia are termed minimal residual diseaseFor Research Use Only diagnosic sample is needed.(MRD) and can be evaluated using sensitive assays. MRD detection by Next-Generation Sequencing has demonstrated utility in predicting clinical outcomesThis test is performed by using the LymphoTrack Assay The tracking of antigen-receptor gene rearrangementsand in generating clinically actionable results, allowingfrom Invivoscribe. Data is analyzed using the LymphoTrackIndications for Testingfor clonality analyses and MRD monitoring can be appliedearly intervention, confirmation of disease status prior toMRD Data Analysis Tool (RUO). Identify tumor-specific markers for post-treatment to virtually all patients. During early T-cell development,transplant, and increased confidence in remission status.the germline variable (V), diversity (D), and joining (J)monitoringfragments of the T-cell receptor beta (TRB) locus becomeMethod Description Monitor and evaluate disease recurrencerearranged through the random deletion or insertion ofTo track and identify previously detected TRB clonal sequences in post-treatment follow-up samples, a multiplex master mix targeting the V, J and D regionsis used for PCR amplification. Next-generation sequencing of the PCR products is used to identify DNA sequences specific to previously identified clonal rearrangements Interpretation TurnaroundSpecimenShippingStorage Time Requirements Conditions ConditionsAn interpretive5 to 14 1-3 mL of peripheral blood Ambient or Cool; 2-8 C up report will bebusiness daysin EDTAdo not freezeto 7 days prior issued indicating(peripheral blood orto testingwhether TRB MRD0.25-1 mL of bone marrow bone marrow) was detected in EDTAAmbient or frozen on 700-3500 ng of previously isolated DNA dependingdry ice (isolated DNA)References on level of sensitivity required1. Rezuke, W.N. 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 110:3112-2146 LabPMM Services Catalog 2020|47'