Verici Dx PLC Tutivia(TM) validation study published in Journal (2501W)
11 Dezember 2023 - 8:00AM
UK Regulatory
TIDMVRCI
RNS Number : 2501W
Verici Dx PLC
11 December 2023
Verici Dx plc
("Verici Dx" or the "Company")
Tutivia (TM) validation study published in The American Journal
of Transplantation
Demonstrates the clinical applicability of Tutivia(TM) to
improve patient outcomes
Verici Dx plc (AIM: VRCI), a developer of advanced clinical
diagnostics for organ transplant, announces that the data from the
Company's successful pivotal international validation study for
Tutivia (TM) has been peer reviewed and published in The American
Journal of Transplantation, the official journal of both the
American Society of Transplantation and the American Society of
Transplant Surgeons with a combined membership of approximately six
thousand transplant professionals.
The publication, entitled 'Prospective observational study to
validate a Next Generation Sequencing blood RNA signature to
predict early kidney transplant rejection' by Bestard, O. et al. is
available in The American Journal of Transplantation, Prospective
observational study to validate a next-generation sequencing blood
RNA signature to predict early kidney transplant rejection -
ScienceDirect.
Tutivia(TM) is the Company's post-transplant blood test that
calculates the risk of all forms of acute rejection, including
borderline, T cell-mediated, and antibody-mediated rejections . The
test was commercially launched in January 2023 to support clinical
care for the estimated c.100,000 global patients who undergo kidney
transplant procedures annually.
Publication in a leading scientific journal is a crucial step in
the commercialisation of a new product as the peer-review process
supports the verification of the reliability and credibility of the
research, building trust and confidence within the scientific
community.
Publication is also a key element in the application by Verici
Dx for Tutivia(TM) to obtain a local coverage determination ("LCD")
for Medicare reimbursement, opening the test up for Medicare
patients and increasing the likelihood of the test being adopted by
centres.
The data from the prospective, blinded study showed that
Tutivia(TM), a next-generation RNA sequencing assay, demonstrates
strong performance in the assessment of risk of acute rejection
following a kidney transplant. Tutivia delivers a significant
improvement in biomarker offerings, particularly early
post-transplant when patient management can be complex and other
biomarkers are contraindicated or less informative. Patients with a
high-risk Tutivia(TM) score are nearly six times as likely to have
acute rejection over those with low-risk results. These findings
confirm Tutivia(TM)'s role in helping improve patient outcomes with
significant implications for clinical care, providing relevant
information for immunosuppression management and supporting
clinical decision making with regard to kidney biopsy.
The strong results were particularly noteworthy given that the
study utilised a generalised 'all-comers' patient population rather
than a specific subgroup and examined performance in both the
for-cause and surveillance settings. The study was purposefully
designed this way to capture the clinical reality across 13
international transplant centres in five countries. As a result,
the data reflects the wide clinical applicability of Tutivia(TM)
for comprehensive commercial adoption in a real-world setting.
Dr. Lorenzo Gallon, Chair of Scientific Advisory Board of Verici
Dx, commented: "I am delighted that the data from our pivotal
validation study for Tutivia (TM) has been published in such a
high-impact and prestigious journal as The American Journal of
Transplantation."
Dr Michael Donovan, Chief Medical Officer of Verici Dx, added:
"This publication further validates the benefits of the test for
kidney transplant patients and their clinicians, and demonstrates
the comprehensive design of the study to reflect the full clinical
continuum. "
Patti Connolly, Chief Operating Officer, concluded: "We are
already seeing growing clinical interest, and as this publication
is key in the application for LCD coverage, we anticipate an
accelerated adoption of Tutivia (TM) within the medical community,
marking a significant step forward in enhancing diagnostic accuracy
and post-transplant patient care ."
Enquiries:
Verici Dx www.v ericidx .com
Sara Barrington, CEO Via Walbrook PR
Julian Baines, Chairman
Singer Capital Markets (Nominated Tel: 020 7496 3000
Adviser & Broker)
Aubrey Powell / Sam Butcher / Jalini
Kalaravy
Walbrook PR Limited Tel: 020 7933 8780 or vericidx@walbrookpr.com
Paul McManus / Sam Allen Mob: 07980 541 893 / 07502 558 258
About Verici Dx plc www.vericidx.com
Verici Dx is a developer of a complementary suite of
leading-edge tests forming a kidney transplant platform for
personalised patient and organ response risk to assist clinicians
in medical management for improved patient outcomes. The underlying
technology is based upon artificial intelligence assisted
transcriptomic analysis to provide RNA signatures focused upon the
immune response and other biological pathway signals critical for
transplant prognosis of risk of injury, rejection and graft failure
from pre-transplant to late stage. The Company also has a mission
to accelerate the pace of innovation by research using the fully
characterised data from the underlying technology, including
through collaboration with medical device, biopharmaceutical and
data science partners.
The foundational research was driven by a deep understanding of
cell-mediated immunity and is enabled by access to expertly curated
collaborative studies in highly informative cohorts in kidney
transplant.
About The American Journal of Transplantation
The American Journal of Transplantation (AJT) is the official
journal of the American Society of Transplantation and the American
Society of Transplant Surgeons. AJT seeks to provide its readership
with literature of both the highest quality and impact through a
process of careful peer review and editorial comment. All papers,
including those invited by the Editorial Board, are subject to peer
review.
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