SAN DIEGO, Nov 8 (Bernama-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®, 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.
About Invivoscribe
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 102 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 to worldwide regulatory authorities
for registration. For additional information please visit www.invivoscribe.com.
CONTACT:
Kevin Dobyns 858-224-6600
SOURCE : Invivoscribe, Inc.
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