148 Reference | Menus Invivoscribe 2019 | 149 Reference Menus Next-Generation Sequencing Menu Gel and Capillary Electrophoresis Menu Invivoscribe offers LymphoTrack and LymphoTrack Dx Assays for the analysis of B- and T-cell clonality, somatic hypermutation, and minimal residual disease studies**. Assays are designed for use on both industry standard next-generation sequencing (NGS) platforms: the Illumina® MiSeq® and Thermo Fisher Scientific® Ion PGM™ and Ion S5™ instruments. Invivoscribe assays for the Illumina® MiSeq® platform offer the ability to analyze up to 22 samples and 2 controls per gene target and the multiplexing capabilities to generate a sequencing library that combines amplicons from different Invivoscribe LymphoTrack and LymphoTrack Dx Assays onto the same flow cell. Our included software then sorts and assigns the correct sequences to their corresponding sample. Invivoscribe assays for the Ion PGM™ and Ion S5™ platform offer the ability to analyze up to 10 samples and 2 controls per gene target and the multiplexing capability to generate a sequencing library that combines amplicons from different Invivoscribe LymphoTrack and LymphoTrack Dx Assays onto the same sequencing chip, reducing per sample testing costs. All LymphoTrack and LymphoTrack Dx Assays allow for fast and easy analysis and data visualization using the included bioinformatics software. The LymphoTrack software sorts and assigns the sequences to their corresponding sample and provides information such as the prevalence, gene segment usage, and the mutation rate (IGH Leader and IGH FR1 only). In addition, the Invivoscribe Minimal Residual Disease (MRD) Software allows for clonotype sequences to be tracked in subsequent samples for research applications. The table below indicates which LymphoTrack (Research Use Only) and LymphoTrack Dx (CE-IVD Marked) Assays are currently available in 2019. Invivoscribe offers assays that can be analyzed using two conventional methods of fragment analysis: gel electrophoresis or capillary electrophoresis. Gel electrophoresis kits offer a comparatively easy and inexpensive solution for clonality, translocation, and mutational testing and are often the method of choice for laboratories new to using these methods and techniques. PCR products are analyzed using non-denaturing polyacrylamide gels (PAGE) and often require a heteroduplex step for resolution of generated amplicons. Capillary electrophoresis kits are supplied with fluorescently labeled primers, allowing the resulting PCR products to be analyzed on Applied Biosystems (ABI) platforms (e.g. 3130, 3500). Fragment analysis by capillary electrophoresis offers the ability to detect fragments with a high level of accuracy and analytical sensitivity and allows for greater sample throughput compared to gel detection methods. In addition, capillary electrophoresis detection often facilitates a more objective interpretation of results than gel-based detection. The table below summarizes which detection methods are available for our clonality and translocation assays either as Research Use Only or CE-marked IVDs. CE-Marked IVD Assays MiSeq® Ion S5/PGM™ LymphoTrack® Dx IGHV Leader Somatic Hypermutation Assays AVAILABLE NOT OFFERED* LymphoTrack® Dx IGH FR1 Assays AVAILABLE AVAILABLE LymphoTrack® Dx IGH FR2 Assays AVAILABLE AVAILABLE LymphoTrack® Dx IGH FR3 Assays AVAILABLE AVAILABLE LymphoTrack® Dx IGH FR1/2/3 Assays AVAILABLE AVAILABLE LymphoTrack® Dx IGK Assays AVAILABLE AVAILABLE LymphoTrack® Dx TRG Assays AVAILABLE AVAILABLE LymphoTrack® Dx TRB Assays AVAILABLE PLEASE INQUIRE Research Use Only (RUO) Assays MiSeq® Ion S5/PGM™ LymphoTrack® IGHV Somatic Hypermutation Assays AVAILABLE NOT OFFERED* LymphoTrack® IGH FR1 Assays AVAILABLE AVAILABLE LymphoTrack® IGH FR2 Assays AVAILABLE AVAILABLE LymphoTrack® IGH FR3 Assays AVAILABLE AVAILABLE LymphoTrack® IGH FR1/2/3 Assays AVAILABLE AVAILABLE LymphoTrack® IGK Assays AVAILABLE AVAILABLE LymphoTrack® TRG Assays AVAILABLE AVAILABLE LymphoTrack® TRB Assay AVAILABLE PLEASE INQUIRE CE-Marked IVD Assays Gel ABI IdentiClone™ IGH + IGK B-Cell Clonality Assay AVAILABLE AVAILABLE IdentiClone™ IGH Gene Clonality Assay AVAILABLE AVAILABLE IdentiClone™ IGK Gene Clonality Assay AVAILABLE AVAILABLE IdentiClone™ IGL Gene Clonality Assay AVAILABLE AVAILABLE IdentiClone™ TCRB + TCRG T-Cell Clonality Assay AVAILABLE AVAILABLE IdentiClone™ TCRB Gene Clonality Assay AVAILABLE AVAILABLE IdentiClone™ T-Cell Receptor Gamma Gene Rearrangement Assay 2.0 NOT AVAILABLE AVAILABLE IdentiClone™ TCRG Gene Clonality Assay AVAILABLE AVAILABLE IdentiClone™ TCRD Gene Clonality Assay AVAILABLE AVAILABLE IdentiClone™ BCL1/JH Translocation Assay AVAILABLE NOT AVAILABLE IdentiClone™ BCL2/JH Translocation Assay AVAILABLE NOT AVAILABLE Research Use Only (RUO) Assays Gel ABI IGH + IGK B-Cell Clonality Assay AVAILABLE AVAILABLE IGH Gene Rearrangement Assay AVAILABLE AVAILABLE IGH Gene Clonality Assay AVAILABLE AVAILABLE IGH Somatic Hypermutation Assay v2.0 AVAILABLE AVAILABLE IGL Gene Clonality Assay AVAILABLE AVAILABLE TCRB + TCRG T-Cell Clonality Assay AVAILABLE AVAILABLE TCRB Gene Clonality Assay AVAILABLE AVAILABLE T-Cell Receptor Gamma Gene Rearrangement Assay AVAILABLE AVAILABLE T-Cell Receptor Gamma Gene Rearrangement Assay 2.0 NOT AVAILABLE AVAILABLE TCRG Gene Clonality Assay AVAILABLE AVAILABLE TCRD Gene Clonality Assay AVAILABLE AVAILABLE BCL1/JH Translocation Assay AVAILABLE NOT AVAILABLE BCL2/JH Translocation Assay AVAILABLE NOT AVAILABLE BCL2/JH t(14;18) Translocation Assay AVAILABLE NOT AVAILABLE BCR/ABL t(9;22) Translocation Assay AVAILABLE AVAILABLE PML/RARA t(15;17) Translocation Assay AVAILABLE AVAILABLE CE-marked assays are in vitro diagnostic products and are not available for sale or use within North America. **Minimal residual disease (MRD) applications are currently for research use only. CE-marked assays are in vitro diagnostic products and are not available for sale or use within North America. * Due to the length of the amplicon and the available sequencing chemistries from Thermo Fisher Scientific, this assay is not available.