b'IGH MRD Clonality Assays MRD TestsBackground Test Name region is used for PCR amplification. Next-generation Combinations of chemotherapy, radiation therapy and(IGH) locus become rearranged through the randomIGH FR1 MRD clonality assaysequencing of the PCR products is used to identify bone marrow transplantation are potentially curativedeletion or insertion of nucleotides within the junctionalIGH FR2 MRD clonality assayDNA sequences specific to previously identified clonal for several hematologic malignancies. However, in someregion, generating specific and unique sequences withinIGH FR3 MRD clonality assayrearrangements detected at diagnosis. Bioinformaticstools facilitate the detection of these specific sequences patients, occult tumor cells exist and are thought to increaseeach lymphocyte. Cancer cells that arise from alterationsIGHV Leader MRD Somatic Hypermutation Clonality Assay present at MRD levels up to 10 -6 . the patients risk of relapse. 1These subclinical levels ofin single lymphoid precursors acquire clonal IGH junctional residual leukemia are termed minimal residual diseaseregions, which can be used as tumor-specific markers. 2-3 Assay Type The assay requires a sample taken at diagnosis as well(MRD) and can be evaluated using more sensitive assays. as the post-treatment follow-up samples. If the patient has The tracking of antigen-receptor gene rearrangementsMRD detection by Next-Generation Sequencing hasNext-Generation Sequencing (NGS)previously been tested by LabPMM for IGH clonality,for clonality analyses and MRD monitoring can be applieddemonstrated utility in predicting clinical outcomesFor Research Use Only no diagnosic sample is needed. to virtually all patients. During early B-cell development,and in generating clinically actionable results, allowingThis test is performed by using the LymphoTrack Assay the germline variable (V H ), diverse (D H ), and joining (J H )early intervention, confirmation of disease status prior tofrom Invivoscribe. Data is analyzed using the LymphoTrackIndications for Testingfragments of the human immunoglobulin heavy chaintransplant, and increased confidence in remission status.MRD Data Analysis Tool (RUO). Identify tumor-specific markers for post-treatment monitoring Method Description Monitor and evaluate disease recurrenceTo track and identify previously detected IGH clonal sequences in post-treatment follow-up samples, a multiplex master mix targeting the conserved framework region 1, framework region 2, or framework region 3, and the joining 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 prior issued indicating(peripheral blood orto testingwhether IGH MRD0.25-1 mL of bone marrow bone marrow) was detected in EDTA700-3500 ng of previouslyAmbient or frozen onisolated DNA dependingdry ice (isolated DNA) on level of sensitivity References 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 110:3112-21.42 LabPMM Services Catalog 2020|43'