Pooled libraries were quantified and sequenced on the ion torrent pgm instrument, with generated fastq files analyzed by lymphotrack pgm software version 2. The lymphotrack igh fr1 assay represents a significant improvement over existing. This software package allows for clonality analysis of single target data igh fr1, igh fr2, igh fr3, igk, or trg as well as for simultaneous analysis of igh fr1, igh fr2, igh fr3, igk, and trg data. Invivoscribes cemarked clonality kits, which allow single step pcr library generation and come with bioinformatics software designed to run on standard windows platforms within customer laboratories, allow for comprehensive multiplex testing of any combination of samples and lymphotrack dx assays e. The lymphotrack pgm software provides a stacked bar graph depicting the relative frequencies for the 200 most common v j rearrangements sequenced and identified in the sample. Igh fr1 assay miseq kit andor the lymphotrack igh somatic hypermutation assay pgm invivoscribe, san diego, ca, usa according to the manufacturers protocols. Invivoscribe has developed a lymphotrack mrd software to. Positive clonal and negative polyclonal dna controls are included in the kit. Invivoscribe gets ce mark for ngs lymphotrack assays genomeweb.
The kits include onestep pcr master mixes with either 12 pgm or 24 miseq individual indices, so when igh and trg assays are run simultaneously, 20 pgm or 44 miseq patient results can be. Lymphotrack bioinformatics software also provides a 3d graph of relative usage frequencies of each of the v and j gene segments. The associated lymphotrack software s5 pgm provides a simple and streamlined method of analysis and visualization of data. The lymphotrack dx trg assay and lymphotrack dx igh fr1 assay kits. The lymphotrack bioinformatics software enables easy analysis and visualization of data and the lymphotrack mrd software allows sequences to be tracked in subsequent samples. Invivoscribes proprietary lymphotrack dx software, which analyzes the. Invivoscribe ceivd lymphotrack dx assays genomeweb. Pdf detection of immunoglobulin heavy chain gene clonality. The proprietary lymphotrack bioinformatics software included in the assay kit directly converts ngs data output to a format that allows you to visualize and analyze the prevalence or frequency distribution of the gene rearrangements and to identify specific dna sequences. Invivoscribe gets ce mark for ngs lymphotrack assays. The lymphotrack dx trg assay assesses tcell receptor gamma rearrangements, while the lymphotrack dx igh fr1 assay assesses immunoglobulin heavy chain gene rearrangements. When the igh and igk assays are used together, its possible to detect clonality in a majority of bcell malignancies with nearly 100 percent clinical sensitivity. The thailand news day is the famous name in the news industry of the asean.
The frequency of identical sequences in ngs was calculated by dividing the number of sequence reads by. Lymphotrack igh somatic hypermutation assay miseq the lymphotrack pgm master mixes are designed with 12 ion xpress indices and adapters for the ion pgm instrument, allowing onestep pcr, pooling of amplicons, and loading onto the chip. Cytotrack technology is a new kind of scanner that is specifically developed for the challenges of scanning and analyzing rare cells, such as circulating tumor cells ctc. Minimal residual disease monitoring with nextgeneration. The lymphotrack minimal residual disease data analysis tool is a bioinformatics data analysis tool that runs on supported microsoft windows platforms. Lymphotrack igh assay invivoscribe technologies, san diego, ca, usa includes a primer set targeting igh loci for preparing multiplex pcr library preparation and can be used on two ngs platforms. Apr 21, 2015 new york genomeweb invivoscribe has received ce marking and launched nextgeneration sequencingbased assays for detecting clonality in hematological malignancies. The associated lymphotrack dx software s5pgm provides direct interpretation of the data generated from lymphotrack dx. Pooled libraries are sequenced on the ion torrent pgm instrument, and generated fastq files are analyzed by lymphotrack pgm software version 2. The lymphotrack dx igh fr1 assay s5 pgm is an in vitro diagnostic product intended for nextgeneration sequencing ngs, targeting the conserved framework 1 fr1 region within the v h segments of the igh gene to determine the frequency distribution of clonal igh v h j h rearrangements as well as the degree of somatic hypermutation shm. This software package allows for clonality analysis of single target data igh fr1, igh fr2, igh fr3, igk, or trg as well as for simultaneous analysis of igh fr1. The invivoscribe portfolio now includes the first comprehensive menu of ceivd clonality assays igh, igk, trg developed for use on thermo fishers ion pgm system.
Igh framework 1 vj amplicon libraries are prepared using invivoscribe primers, pgm adapters, and patient sample dna. Detection of immunoglobulin heavy chain gene clonality by next. Using lymphotrack deepseq assays on illumina miseq to. Lymphotrack igh assay invivoscribe technologies, san diego, ca, usa. The website is to gather and publish news of all kinds on a daily basis and covers almost every industry with aim to provide the everchanging insights of every industry to its readers. Next generation sequencing demonstrates clinical utility. Leukemias and lymphomas generally originate from the malignant transformation of individual lymphoid cells, causing the vast majority of lymphoid malignancies to share one or more cellspecific or clonal. This cd includes detailed instructions for installation and use of the software package, as well as two essential tools for analysis.
The thailand news day is the famous name in the news industry of the asean region and has been in the news industry for a long time. The lymphotrack igh fr1 assays provide the degree of shm of the immunoglobulin variable heavy chain. The lymphotrack bioinformatics software enables simplified analysis and visualization of data generated from this assay. May 15, 2018 the lymphotrack dx trb assay identifies clonal trb v. The intended use of this software is to detect the presence of a clonotype sequence within the output from an invivoscribe lymphotrack assay. Detection of immunoglobulin heavy chain gene clonality by. Apr 21, 2015 the lymphotrack dx trg assay and lymphotrack dx igh fr1 assay kits provide clinical laboratories both the reagents and the bioinformatics tools necessary for them to identify and track clonal populations in pathologic samples in their own laboratories. Fortyeight of the 60 samples showed highfrequency rearrangements in at least one of the three markers analyzed, with igh vdj being the most instructive 4460, 73%. Feb 28, 2017 the invivoscribe portfolio now includes the first comprehensive menu of ceivd clonality assays igh, igk, trg developed for use on thermo fishers ion pgm system.
These ceivd assays, developed for use with the leading nextgeneration sequencing ngs platforms, include optimized multiplex pcr master mixes with primers incorporating platform specific adapters and specimen tracking sequencing identification tags for a onestep. Invivoscribe, inc invivoscribe releases the lymphotrack. The lymphotrack dx trb assay for the thermofisher scientific ion pgm and ion s5 instruments will be released later this year. Molecular genetic data favoring a sequential clonal. Pdf differences between bcl2break positive and negative.
San diego, may 15, 2018 globe newswire invivoscribe technologies inc. Invivoscribe technologies has launched three new cemarked in vitro diagnostic assays for the companys ion pgm dx system. Invivoscribe lymphotrack dx assays are used to identify and track clonal lymphocyte populations. Controls igh tds positive control dna, igh tds negative control dna master mix name igh tds 01 igh tds 02 igh tds 03 igh tds 04 igh tds 05 igh tds 06 igh tds 07 igh tds 08 index number a001 a002 a003 a004 a005 a006. We identified clonal igh rearrangements in 43 of 51 84% cases and found that the number of evolved igh sequences per patient ranged dramatically from 0 to 4,024. Invivoscribe releases the lymphotrack dx trb assay as ce. The new assays include an igh, igk, and trg clonality assays to aid in the diagnosis of bcell malignancies. The basic idea behind cytotrack is closely related to conventional cddvd technology. Invivoscriber launches four cemarked ngsbased lymphotrack. A singlestep pcr library preparation is followed by standard miseq or pgm sequencing. Lymphotrack dx ivd assay kits are designed for the identification of gene arrangements in haematologic samples utilising ngs technologies.
Identification of sequence information and v hj h segment utilization. This lymphotrack dx igh fr1 assay pgm represents a significant improvement over existing. Using lymphotrack deepseq assays on illumina miseq to identify and track clonal cell populations june 18, 20 jeffrey miller, ph. May 15, 2018 invivoscribe releases the lymphotrack dx trb assay as cemarked ivd kit, completing the ngs clonality suite for the miseq platform press release globenewswire may. Igh rearrangement was tested by using fluorescence pcrfragment analysis and the ngs assay in eight ball patients. This allows for a onestep pcr reaction to generate sequenceready amplicons and pooling of several dierent samples on the same illumina miseq flow cell or ion pgm chip. The invivoscribe portfolio of lymphotrack igh miseq assays represent a significant improvement over view product.
Pgm, the high number of clonotype sequences present in an initial sample. Pgm sequencing 400 kit all from thermo fisher scientific. Lymphotrack dx assays ceivd bioconnect diagnostics. Apr 21, 2015 invivoscribes proprietary lymphotrack dx software, which analyzes the fastq files generated by the miseq or ion pgm instruments and runs on standard windows based platforms, is included with. The lymphotrack dx igh fr3 assay s5 pgm is an in vitro diagnostic product intended for next generation sequencing ngs for the thermo fisher scientific ion pgm and ion s5 instruments. International validation of a harmonized ngs pgm assay at clinical laboratories in the us and the eu. Lymphotrack dx ivd assay kits are designed for the identification of gene arrangements in haematologic samples utilising ngs technologies invivoscribe ngs assays offer. Release of the lymphotrack dx trb assay for the ion pgm system is scheduled for later this year. The lymphotrack dx pgm master mixes are designed with 12 ion xpress indices and adapters for the ion pgm instrument, allowing onestep pcr, pooling of amplicons, and loading onto the chip. Invivoscribe lymphotrack dx ivd assays now available. These assays were validated using a variety of clinical samples, including difficult to test. This lymphotrack dx software s5 pgm 95000007 was developed specifically for and is. Ion pgm instruments and runs on standard windows based platforms.
The lymphotrack mrd data analysis tool was then used to detect the known clonal sequence in subsequent samples table 2. The invivoscribe portfolio now includes the first comprehensive menu of ceivd clonality assays igh, igk, trg developed for use on thermo fishers ion pgm tm system. Pgm software provides interpretation of the data via a simple. This assay aids in the identification of lymphoproliferative disorders using the thermo fisher scientific ion s5 or ion pgm platform. The sample is spread on a special glass disc cytodisc. The assay will determine the frequency distribution of igh v hj h gene rearrangements in patients suspected of having lymphoproliferative disease. Lymphotrack igh fr123 assay panel miseq invivoscribe. Lymphotrack dx igh fr1 assay miseq lymphotrack dx igk assay miseq lymphotrack dx trg assay miseq. Dna abundance of t and b cells and tested with the lymphotrack igh fr1 assay for the miseq or ion pgm input dna quantity was adjusted to 700 ng per dilution point. This research use only assay identifies clonal trg vj rearrangements, the associated vj region dna sequences, and provides the frequency distribution of v region and j region segment utilization using the illumina miseq or thermo fisher life technologies ion pgm. The lymphotrack bioinformatics software enables simplified analysis and visualization of. Invivoscribe, inc invivoscribe releases the lymphotrack dx. Lymphotrack igh assay invivoscribe technologies, san diego, ca, usa includes a primer.
Multiplex master mix for igh targets the conserved framework region 1 fr1 within the vh and the jh regions, while multiplex master mix for trg. Thermo fisher scientific, waltham, ma, usa and the miseq system illumina, san diego, ca, usa. Lymphotrack dx ivd assay kits are designed for the identification of gene arrangements. Next generation sequencing demonstrates clinical utility and. Abacus dx is pleased to inform you that the invivoscribe lymphotrack dx ivd assays are now available. Jun 10, 2019 the method was established with the igh vdj, igh dj, and igk genes. Igh framework 1 vj amplicon libraries were prepared using invivoscribe panel primers, pgm adapters, and patient sample dna. The lymphotrack pgm software provides a 3d graph of relative usage frequencies of each of the v and j gene segments. Bioinformatics software for simple, automated visualization of data and analysis unparalleled. Positive and negative controls for clonality are included in the kit. The lymphotrack dx pgm software provides a stacked bar graph depicting the relative frequencies for the 200 most common v j rearrangements sequenced and identified in a sample. The proprietary lymphotrack bioinformatics software included in the assay kit directly converts ngs data output to a format that.
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