b'Next-Generation Sequencing (NGS) | CE-IVD AssaysIGH Assay Next-Generation Sequencing (NGS) | CE-IVD AssaysLymphoTrack Dx IGH FR1/2/3 AssaysAssay Description These assays utilize a single multiplex master mix to target each conserved IGH Framework Region (FR1, FR2, and FR3) within the V HLymphoTrack Dx IGH FR1 Assaysand the J Hregions described in lymphoid malignancies. The included The LymphoTrack Dx IGH FR1 Assay for the Illumina MiSeq orprimers are designed with Illumina or Thermo Fisher Scientific Thermo Fisher Scientific Ion S5 TMand Ion PGM TMis an in vitroadapters and indices (8-24 and 12, respectively).diagnostic product intended for next-generation sequencingThis allows up to 24 samples on MiSeq and 12 samples on Ion (NGS) based determination of the frequency distribution ofPGM and Ion S5 to be sequenced at the same time with any of the IGH gene rearrangements as well as the degree of somaticindividual FRs. hypermutation of rearranged genes in patients suspected with having lymphoproliferative disease.This assay aids in the identificationIn addition, amplicons generated with different FR master mixes or of lymphoproliferative disorders as well as providing an aid inInvivoscribe LymphoTrack Dx kits (such as IGK or TRG) can be pooled determining disease prognosis. together in the same sequencing library to reduce testing costs. LymphoTrack Dx IGH FR1/2/3 AssaysThe associated LymphoTrack Dx Software provides interpretation The LymphoTrack Dx IGH FR1 Assay for the Illumina MiSeq orof the data via a simple and streamlined method of analysis and Thermo Fisher Scientific Ion S5 TMand Ion PGM TMis an in vitrovisualization. By following the guidelines provided in the instructions diagnostic product intended for next-generation sequencingfor use, samples can be interpreted for evidence of clonality (NGS) based determination of the frequency distribution ofand SHM rates.IGH gene rearrangements as well as the degree of somaticPositive clonal (SHM negative) and negative polyclonal DNA controls hypermutation of rearranged genes in patients suspected with havingare included in kits. A clonal SHM positive control can be purchased lymphoproliferative disease.This assay aids in the identificationseparately (cat#: 4-088-0008).of lymphoproliferative disorders as well as providing an aid in determining disease prognosis.BackgroundThis LymphoTrack Dx IGH FR2 Assay is an in vitro diagnostic product intended for next-generation sequencing (NGS) for the IlluminaThe human immunoglobulin heavy chain (IGH) gene locus on MiSeq or Thermo Fisher Scientific Ion S5 TMand Ion PGM TM chromosome 14 (14q32.3) includes 46-52 functional and 30 non-instruments. The assay will determine the frequency distribution offunctional variable (V H ), 27 functional diversity (D H ), and 6 functional IGH V H -J Hgene rearrangements in patients suspected with havingjoining (J H ) gene segments. The V Hgene segments can be further lymphoproliferative disease.This assay aids in the identification ofbroken down into three conserved frameworks (FR) and three lymphoproliferative disorders. variable complementarity-determining regions (CDRs).The LymphoTrack Dx IGH FR3 Assay is an in vitro diagnostic productDuring development of lymphoid cells, antigen receptor genes intended for next-generation sequencing (NGS) for the Illuminaundergo somatic gene rearrangements. Specifically during MiSeq or Thermo Fisher Scientific Ion S5 TMand Ion PGM TM B-cell development, IGH molecules are assembled from multiple instruments.The assay will determine the frequency distribution ofpolymorphic gene segments that undergo rearrangements IGH V H -J Hgene rearrangements in patients suspected with havinggenerating V H -D H -J Hcombinations unique in both length and lymphoproliferative disease.This assay aids in the identification ofsequence. Since leukemias and lymphomas originate from the lymphoproliferative disorders. malignant transformation of individual lymphoid cells, all leukemias and lymphomas generally share one or more cell-specific or clonal Summary and Explanation of the Test antigen receptor gene rearrangements.The LymphoTrack Dx IGH Assays represent a significant improvementIn addition, the IGHV hypermutation status obtained with the over conventional clonality assessment methods utilizing fragmentLymphoTrack Dx IGH FR1 master mixes, provides important prognostic analysis by providing four important and complementary uses in ainformation for patients with chronic lymphocytic leukemia (CLL) and single workflow: small lymphocytic lymphoma (SLL). The SHM rate has been shown to have clinical relevance for CLL, as there is a clear distinction in the 1.Detection of clonal populations. median survival of patients with and without SHM. 12.dentification of sequence information required to track clonal Irearrangements in subsequent samples. Specimen Requirement3. The LymphoTrack Dx IGH framework 1 FR1 master mixes provide 50 ng of high-quality genomic DNA.the degree of SHM in the immunoglobulin variable heavy chain (IGHV) gene locus. References4.The ability to track sequences in subsequent samples with the 1.P Ghia et al., Blood 105: 1678-1685 (2005).Invivoscribe LymphoTrack MRD* Software. For more information, please refer to page 52 and 53. 22*MRD Software can be used to track sequences generated by either LymphoTrack Assays- MiSeq or Ion S5/PGM. MRD applications are for Research Use Only. To obtain a copy, please contact your local distributor or send an e-mail to customerservice@invivoscribe.com'