REG - Verici Dx PLC - Further data from Tuteva™ validation study

Verici DxAnnouncement

14/06/2022 09:00

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RNS Number : 7848O  Verici Dx PLC  14 June 2022

Verici Dx plc

("Verici Dx" or the "Company")

 

Further data from Tuteva™ clinical validation study presented

 

Performance in blinded multi-centre trial establishes new industry standard in
detection of acute kidney transplant rejection and paves way for US commercial
launch in 2022

 

Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for
organ transplant, announces that the additional data from its blinded,
international, multi-centre validation study for Tuteva™, the Company's
post-transplant blood test focused on acute rejection, has been presented at
the American Transplant Congress ("ATC") earlier this month.

 

The further data demonstrates a Positive Predictive Value ("PPV") of 60% and
Negative Predictive Value ("NPV") of 80% for Tuteva™, a next-generation RNA
sequencing assay. This and the ability to detect all types of rejection
support improved clinical diagnosis compared to that currently available from
other kidney transplant blood tests without enhancement from clinical
features, and in a broad validation population. This data confirms that
Tuteva™ demonstrates strong performance in the detection of acute rejection,
following a kidney transplant. These clinically important results position
Tuteva™ for an on-schedule commercial launch later this year to support the
estimated c. 100,000 global patients who undergo kidney transplant procedures
annually.

 

The study design and successful outcomes were well received at ATC and the
poster, presented at the Congress and referenced during the closing session of
the "What's new / What's hot" roundup, is now available on the Company website
here: https://vericidx.com/clinical (https://vericidx.com/clinical)

 

Further details can be seen in the poster, but key conclusions from the study
are outlined below:

 

 •    Validation in an all-comers cohort(1) that is independent of the training set
      and representing all forms and levels of rejection is essential to assessment
      of expected test performance in translational clinical care settings to
      support medical management decision making.

      (1)The validation study utilised a generalised 'all-comers' patient population
      rather than a specific subgroup. The Tuteva™ study was purposefully designed
      this way to capture the clinical reality of all types of rejection, including
      sub-clinical, borderline, T Cell-mediated, and antibody-mediated rejection
      across 14 international transplant centres. The results reflect the wide
      clinical applicability of the test for comprehensive commercial adoption in a
      real-world setting.

 •    Prospective, multicenter, international studies allow for the inclusion of
      diverse populations and broad diversity in care management practices while
      allowing blinding to protect from introduction of biases; thereby producing
      robust and reliable results for clinical integration.

 •    Tuteva is a quantitative blood-based transcriptomic signature able to
      correlate an acute rejection risk score with rejection phenotype based on
      histopathology in the kidney biopsy, representing a level of evidence which
      has not yet not existed in biomarker transplant biology.

 

The trial continues for new validations of other pre and post-transplant tests
which are included in the trial objectives, and patients will be monitored
in-study at local sites for two years.  Further data will be useful in
supporting the utility of Tuteva(TM) and its apparent ability to also track
changes in rejection status, as appeared to be shown by the test and biopsy
results of a sub-group of 12 patients in the sample who received multiple
biopsies.  Should additional data support this finding in a larger sample
over time, it will confirm that Tuteva(TM) is measuring relevant rejection
markers reliably over time, which is important for clinical monitoring.

 

Sara Barrington, CEO, Verici Dx, said: "I'm delighted that the data shows that
our underlying technology has the potential to be clinically groundbreaking,
particularly as we focus on commercial launch later this year with the goal of
making this much needed test available to all kidney transplant patients, so
that an earlier clinical diagnosis can better inform their medical
management."

 

The publication of this data follows on from the recently announced senior
appointments of Grant Harvey and Dr. Windy Tucci as Business Development
Director and Medical Science Liaison Director respectively, to further
strengthen the Verici Dx team ahead of planned commercial launch later this
year.

 

In addition, Verici Dx expects to announce multi-centre clinical validation
results for Clarava™, the pre-transplant prognostic test this summer, having
completed additional tissue type matching analysis to support the data
evaluation.

 

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 / Kailey Aliyar / Tom Salvesen

 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 and 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.

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