b'ClonalityTestsTest Name hypermutation present in the IGH gene. Bioinformatics IGHV Leader Somatic Hypermutation Assay tools facilitate the characterization of sequences present at greater than 2.5% of the population and the level of somatic hypermutation present in the dominant clone. Assay Type Bioinformatics also identify clonal rearrangements that involve the V3-21 gene, which has been associated withNext-Generation Sequencing (NGS) a poor prognosis in CLL, independent of SHM status.This test is performed by using the LymphoTrack or LymphoTrack Dx Assay from Invivoscribe. Indications for Testing dentify clonality in atypical lymphoproliferative IMethod Description disordersFor detection of the vast majority of clonal IGH V H -J HSupport a differential diagnosis between reactiverearrangements, including the associated V H -J Hregion DNAlesions and hematologic malignanciessequences, a multiplex master mix targeting the conservedAssign presumptive lineage in mature monoclonalframework region 1 (FR1) or leader and the joining regionlymphoproliferative disordersis used for PCR amplification. Next-generation sequencingMonitor and evaluate disease recurrenceof the PCR products is used to identify the frequency distribution of V Hregion and J Hregion segment utilization, as well as for the definition of the extent of somatic Interpretation TurnaroundSpecimenShippingSpecimen Time Requirements Conditions StabilityAn interpretive report will be5 to 10 1-3 mL Peripheral BloodAmbient or2-8 C up issued indicating the levelbusiness daysin EDTA, ACD or Heparin Cool; do notto 7 days prior of IGH SHM along with thefreeze (peripheralto testingrearrangement class for the0.25-1 mL of boneblood or bone dominant clones and themarrow in Heparin,marrow) specific sequence for theEDTA or ACD500 ng of previouslyAmbient or dominant clone.isolated DNA frozen on dry ice (isolated DNA)LabPMM Services Catalog 2021|27'