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 1 x 10 -6with sufficient DNA input.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 typically requires a sample taken at diagnosis as patients, occult tumor cells exist and are thought to increaseprecursors acquire clonal TRB junctional regions which canwell as the post-treatment follow-up samples. If the patient the patients risk of relapse. 1These subclinical levels ofbe used as tumor-specific markers. 2,3 Next-Generation Sequencing (NGS)has previously been tested by LabPMM for TRB clonality, no residual leukemia are termed minimal residual diseaseFor Research Use Only diagnostic 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 Software (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 TurnaroundSpecimenShippingSpecimen Time Requirements Conditions StabilityAn 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 priorissued indicating0.25-1 mL of bone marrow (peripheral blood orto testingwhether TRB MRDbone marrow) was detected in EDTA700-3500 ng of previouslyAmbient or frozen onisolated 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 110:3112-2144 LabPMM Services Catalog 2021|45'