Invivoscribe® Technologies Inc., a global company with decades of experience providing clonality and biomarker test solutions for the fields of oncology and personalized molecular medicine®, announces the release of the Research Use Only (RUO) version of its LymphoTrack® TRB Assay for the Illumina MiSeq® platform. Included with the assay is specialized bioinformatics software that allows researchers and pharmaceutical companies conducting clinical trials, to identify and track clonal populations by performing minimal residual disease (MRD) testing of subsequent samples.
Tests that detect TRB clonal rearrangements are useful in the study of T-cell malignancies as leukemias and lymphomas generally share one or more cell-specific or “clonal” antigen receptor gene rearrangement(s). The LymphoTrack TRB Assay on MiSeq® identifies clonal TRB (VDJ) rearrangements, the associated VDJ region DNA sequences, and provides the frequency distribution of V, D, and J, region segment utilization using the included LymphoTrack bioinformatics software. This assay will increase the probability of identifying T cell receptor beta chain gene rearrangements versus when testing for TRG gene rearrangements only.
The LymphoTrack TRB Assay completes the comprehensive menu of Invivoscribe LymphoTrack Clonality Assays which enable rapid clonal rearrangement identification with the unparalleled accuracy and sensitivity of next generation sequencing (NGS). The LymphoTrack product line allows customers to simultaneously run any combination of assays, thus significantly reducing both cost and time to results. The kit includes LymphoTrack MiSeq® software which automates the sorting and individual tracking of each sample and IGH, IGK, TRG and TRB target, interprets sequence data, and generates succinct, yet comprehensive reports for each sample and each target. The LymphoTrack MRD software enables temporal tracking of clonal populations, and has demonstrated potential to improve subject monitoring in clinical trial and research settings. Both the LymphoTrack MiSeq® and MRD software programs facilitate international standardization and objective interpretation for clonality and MRD testing. Invivoscribe will also seek CE IVD marking of a LymphoTrack TRB Assay for sale of kits to laboratories outside North America, and 510(k) clearance in the United States. We have already started this process for our menu of LymphoTrack Clonality Assays.
Invivoscribe Technologies Inc. is a privately held biotechnology company dedicated to improving the quality of healthcare worldwide by providing high quality, reliable, cutting-edge reagents, tests, and bioinformatics tools to advance the fields of personalized molecular diagnostics® and personalized molecular medicine. Invivoscribe provides PCR and NGS-based reagents and bioinformatics software designed and manufactured in an ISO 13485 accredited facility registered with the FDA; RUO test kits; CE-marked IVDs, including IdentiClone® and LymphoTrack Dx Assays with both LymphoTrack and LymphoTrack Dx Software; for clonality, MRD, and somatic hypermutation testing. Invivoscribe’s clinical laboratories also offer comprehensive MyAML®, MyHeme®, MyMRD®, and custom gene panels, that when used in combination with Invivoscribe’s proprietary MyInformatics® Software can identify and track primary driver mutations as well as the subclonal architecture and emergence of new driver mutations in patients with hematologic disease. Invivoscribe’s clinical laboratories in the USA, Europe, and Japan provide international access to harmonized CLIA, CAP, and ISO 15189 accredited clinical testing and contract research organization (CRO) services. Invivoscribe’s tests, reagents and bioinformatics tools are currently being used in more than 700 clinical and research laboratories in more than 100 countries. Invivoscribe also has proven expertise in development and commercialization of companion diagnostics. As a global leader, Invivoscribe has long embraced the value of quality systems and develops all IVD products, including bioinformatics software in compliance with ISO 13485 design controls, making them eligible to be submitted for registration to worldwide regulatory authorities. For additional information please visit www.invivoscribe.com.