REG - Verici Dx PLC - Tutivia™ validation study published in Journal

Verici DxAnnouncement

11/12/2023 07:15

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RNS Number : 2501W  Verici Dx PLC  11 December 2023

Verici Dx plc

("Verici Dx" or the "Company")

 

Tutivia™ validation study published in The American Journal of
Transplantation

 

Demonstrates the clinical applicability of Tutivia™ 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™ 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
(https://www.sciencedirect.com/science/article/pii/S1600613523007232) .

 

Tutivia™ 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™ 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™, 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™
score are nearly six times as likely to have acute rejection over those with
low-risk results. These findings confirm Tutivia™'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™ 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™ 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™ within
the medical community, marking a significant step forward in enhancing
diagnostic accuracy and post-transplant patient care."

 

Enquiries:

 

 Verici Dx                                                www.v (http://www.vericidx.com) ericidx (http://www.vericidx.com) .com
                                                          (http://www.vericidx.com)
 Sara Barrington, CEO                                     Via Walbrook PR
 Julian Baines, Chairman

 Singer Capital Markets (Nominated Adviser & Broker)      Tel: 020 7496 3000
 Aubrey Powell / Sam Butcher / Jalini Kalaravy

 Walbrook PR Limited                                      Tel: 020 7933 8780 or vericidx@walbrookpr.com
                                                          (mailto:renalytix@walbrookpr.com)
 Paul McManus / Sam Allen                                 Mob: 07980 541 893 / 07502 558 258

 

 

About Verici Dx plc www.vericidx.com (http://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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