b'Background Test Algorithm for Suspect LymphoproliferationsDeveloped in concert with the EuroClonality/BIOMED-2 group for PCR-based clonality assessment of suspected B- and T-cell lymphoproliferative disorders.PCR & NGS-Based Assessment ofMalignant cells that remain in the bone marrow following treatment are a major cause of disease relapse. MRD testing by NGS offersIf a definitive diagnosis is not possible following:Clonality in Hematologic Malignancies enhanced sensitivity and specificity (compared to MRD testing by flow cytometry), and allows residual cells to be identified at very low levelsMorphology ImmunohistochemistryFlow CytometryOver its 25 year history, Invivoscribe has developed, manufactured,and monitored throughout the different stages of disease.and commercialized the gold-standard molecular hematopathologyInvivoscribe can provide you with the necessary tools to accommodate assays and reagents for gel and capillary electrophoresis detection,your needs. From gel detection to NGS, we can help you accurately and most recently, next-generation sequencing instruments. identify and track hematologic biomarkers.These standardized, cGMP manufactured assays and reagentswere developed and validated using standardized workflow andFor additional information on the detection methods available and the optimized primer sets, reagents and controls. biomarkers offered, please refer to the respective product sections ofSuspected lymphoid A number of our products were developed in collaboration withthis catalog.Suspected B-cell proliferations proliferationsSuspected T-cell proliferationsstudies conducted by the EuroClonality BIOMED-2 concerted actionof unknown origingroup; these capillary based products have provided reliable methods(B or T)for clonality detection that have withstood the test of time. Immunoglobulin and T-Cell Receptor We have never accepted the status quo, so our comprehensive menuGene Rearrangements and the Principle of clonality assays continues to evolve. All of our NGS-based clonalityand Method of Clonality Testing Mantle CellFollicular assays were developed in-house together with accompanyingLymphoma Lymphoma TCR+proliferationsbioinformatics software by our Invivoscribe R&D team. DevelopedThe adaptive vertebrate immune system produces a repertoire and immatureunder full ISO 13485 design control, these assays and bioinformaticsof immunoglobulin and T-cell receptor molecules using a relativelyT-cellssoftware were designed to run on several next-generation sequencinglimited number of heritable germline gene segments. SomaticIGH- IGH-platforms. These NGS-based assays are several generations ahead ofgene rearrangement is the fundamental mechanism used toCCND1* BCL2capillary-based products. generate different immunoglobulin and T-cell receptor molecules, Our comprehensive bioinformatics software not only provides criticaleach with unique binding specificity. Lymphocytes undergo gene information on the presence of clonality, but also identifies therearrangements to assemble CDR3 coding regions that are unique IGH (V H -J H ) Clonal TRB sequence information required to track clones in subsequent samples. in both size and DNA sequence. Since leukemias and lymphomas arisepreferably with (generally multiple preferably withfrom the malignant transformation of a single cell, they share clonalIGK clonal results) TRGThe unique process of gene rearrangement that occurs within therearrangement(s) of the antigen receptor genes. This is the basisimmunoglobulin (Ig) and T-cell receptor (TCR) gene loci duringfor clonality testing. 3immune cell development and maturation generates a vast pool of genetically distinct cells. The resulting diverse population ofReferences:lymphocytes displays an astonishing number of diverse antigen1.Tonegawa, S. Somatic Generation of Antibody Diversity. No clonality but still suspected ANDreceptors, each coded in the DNA by a unique sequence, and eachNature 302:575-581 (1983)displayed on the cell surface, or as antibodies in the blood uniqueto a given cell. 1,2This diversity allows the adaptive immune system to2.Expression of T-cell receptor genes during early T-cell development. carry out its role in protecting the human body by recognizing theImmunol Cell Biol. 2008 Feb;86(2):166-74. Epub 2007 Oct 23. infinite number of pathogens it might encounter during a lifetime. 3. Miller, J. E. (2013). Principle of Immunoglobulin and T cell ReceptorIGH (D H -J H )In sum, lymphoid malignancies are characterized by size- andGene Rearrangement. In Cheng, L., Zhang, D., Eble, J. N. (Eds),preferably with Clonal TRDsequence-specific rearrangements within these loci, which result Molecular Genetic Pathology (2nd Ed., Sections 30.2.7.13 and from the transformation and subsequent proliferation from a single30.2.7.18). pp825856. New York, USA: Springer Science & IGLcell. The associated cellular population typically shares one or moreBusiness Media.cell-specific or clonal antigen-receptor gene rearrangements.The detection of these clonal cells forms the basis for clonality assessment in leukemia, lymphoma, and hematologic disease.These methods can also be used to assess somatic hypermutationNo evidence(SHM) and to study minimal residual disease (MRD). of clonality*Previously known as BCL1/J HResults should be considered in the context of all available clinical, histological and immunophenotypic data.18Invivoscribe 2021|19'