b'Next-Generation Sequencing (NGS) | CE-IVD AssaysTRG Assay Next-Generation Sequencing (NGS) | CE-IVD AssaysLymphoTrack Dx TRG AssayAssay DescriptionThe LymphoTrack Dx TRG Assays for the IlluminaMiSeq,ThermoThe TRG gene locus on chromosome 7 (7q14) includes 14 V (variable Fisher Scientific Ion PGM or Ion S5 instruments are in vitro diagnosticregion) genes (Group I, II, III, and IV), 5 J (joining region) gene products intended for next-generation sequencing (NGS) basedsegments, and 2 C (constant region) genes spread over 200 kilobases.determination of the frequency distribution of TRG gene rearrangements in patients suspected with having lymphoproliferative disease. TheseDuring development of lymphoid cells, antigen receptor genes assays aid in the identification of lymphoproliferative disorders. undergo somatic gene rearrangements. Specifically during T-cell development, genes encoding TRG molecules are assembled from multiple polymorphic gene segments that undergo rearrangement Summary and Explanation of the Test generating V-J combinations unique in both length and sequence. These assays utilize a single multiplex master mix to target conservedSince leukemias and lymphomas originate from the malignant V and J regions of the human T-cell receptor gamma (TRG) gene thattransformation of individual lymphoid cells, all leukemias and are described in lymphoid malignancies. Primers are designed withlymphomas generally share one or more cell-specific or clonal Illumina or Thermo Fisher Scientific adapters and up to 24 differentantigen receptor gene rearrangement. Therefore, tests that detect indices; thereby allowing amplicons generated from different TRGTRG clonal rearrangements can be useful in the study of B- andmaster mixes to be pooled together for sequencing on a singleT-cell malignancies.MiSeq flow cell, or Ion PGM or Ion S5 chip.The associated LymphoTrack Dx Software sorts complex NGS data bySpecimen Requirementgene target, providing users the ability to reduce per sample testing50 ng of high-quality genomic DNA.costs by sequencing amplicons generated with any LymphoTrack Dx Assay (e.g. IGH, IGK, TRB, TRG) at the same time. In addition, the LymphoTrack Dx Software provides an easy and streamlined methodReferencesfor data visualization and guidelines provided in the instructions for use allow samples to be interpreted for evidence or no evidence of clonality. 1.S Tonegawa. Nature 302: 575-581 (1983).2. JE Miller et al., Molecular Genetic Pathology (2nd ed.). Springer Positive clonal and negative polyclonal DNA controls are included in kits.Science & Business Media. 2013: 30.2.7.13.BackgroundThe LymphoTrack Dx TRG Assays represent a significant improvement over existing fragment analysis clonality assays by providing two important and complementary uses:1.Detection of initial clonal populations.2.dentification of sequence information required to track clonal Irearrangements in subsequent samples.Simplified Representation of the TRG GeneDepicted are the variable region (V) genes and downstream consensus joining region genes (J) that are involved in TRG gene rearrangements.28'