Invivoscribe Releases the LymphoTrack Dx TRB Assay as CE-Marked IVD Kit, Completing the NGS Clonality Suite for the MiSeq Platform
SAN DIEGO, May 15, 2018 (GLOBE NEWSWIRE) — 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, today announced the release of the LymphoTrack® Dx TRB Assay for the Illumina® MiSeq® platform, a CE-marked next-generation sequencing (NGS) assay kit for in vitro diagnostic (IVD) use. Invivoscribe is the only company offering a complete suite of CE-marked NGS clonality assays designed to assess clonality for both diagnostic and tracking purposes. The LymphoTrack Dx TRB Assay for the ThermoFisher Scientific® Ion PGM™ and Ion S5™ instruments will be released later this year.
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 cell-specific or “clonal” rearrangements. The LymphoTrack Dx TRB assay identifies clonal TRB Vβ-(Dβ-)Jβ rearrangement sequences, and the accompanying LymphoTrack Dx bioinformatics software provides a clear summary of the frequency distribution. These clonal sequences can be used to monitor minimal residual disease (MRD) in longitudinal studies, which track the disease as well as the effectiveness of therapies aimed towards their eradication.
The LymphoTrack Dx TRB Assay completes the menu of Invivoscribe’s CE-marked clonality assays on the MiSeq®, leveraging the unparalleled accuracy and sensitivity of next generation sequencing (NGS), enabling small and large laboratories alike to identify and track clonal rearrangements. Invivoscribe’s CE-marked 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.g. IGH Leader, IGH FR1, IGH FR2, IGH FR3, IGK, TRG, and TRB), thus significantly reducing both laboratory costs and turnaround times. Deep-sequencing NGS assays represent a significant improvement over existing PCR-based assays. They accurately identify the majority of gene rearrangement sequences, or clonotypes, which can subsequently be used for MRD tracking. Each kit includes user-friendly LymphoTrack Dx MiSeq® software that automates the sorting and tracking of each sample and target, interprets sequence data, and generates detailed reports.
“We are pleased to offer the first commercially available NGS CE-marked IVD TRB kit, with bioinformatics software, for clonality assessment and tracking. Innovative products like our NGS-based LymphoTrack Dx Assays directly benefit patients by guiding precision treatments and enabling exceptionally sensitive monitoring for disease reoccurrence,” said Dr. Jeffrey Miller, CSO and CEO of Invivoscribe.
Invivoscribe Technologies, Inc. is a privately held biotechnology company dedicated to improving the quality of healthcare worldwide by providing high quality, standardized reagents, tests, and bioinformatics tools to advance the fields of personalized molecular diagnostics and personalized molecular medicine. The extensive product portfolio includes RUO test kits, CE-marked IVDs, including IdentiClone®, LeukoStrat® and LymphoTrack Dx Assays with LymphoTrack Dx Software to assess clonality, somatic hypermutation and monitor MRD. Invivoscribe’s PCR and NGS-based tests, reagents and bioinformatics tools are currently being used in more than 700 clinical and research laboratories in more than 160 countries. Invivoscribe currently has clinical laboratories located in the U.S.A., Europe and Japan which provide international access to harmonized CLIA, CAP, and ISO 15189 accredited clinical testing and contract research organization (CRO) services. 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 also has a subsidiary in Shanghai, China that is now supporting clinical trial work in China. Invivoscribe has a successful track record of partnerships with global pharmaceutical companies developing and commercializing companion diagnostics. As a world leader, Invivoscribe has long embraced the value of quality systems, and develops all innovative products, including bioinformatics software in compliance with ISO 13485 design controls, making them eligible to be submitted to worldwide regulatory authorities for registration.
For additional information please visit www.invivoscribe.com.
Kevin Dobyns 858-224-6600