REG - Verici Dx PLC - Clinical Validation Study Update

Verici DxAnnouncement

01/04/2022 07:00

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RNS Number : 8671G  Verici Dx PLC  01 April 2022

Verici Dx plc

("Verici Dx" or the "Company")

 

Clinical Validation Study Update

 

 Strategic decision to expand study without impacting commercial pathway

 

Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for
organ transplant, announces that whilst it has met the study size criteria, a
decision has been taken to expand its clinical validation study for its lead
products, Clarava(TM) and Tuteva(TM) , by approximately four to six weeks to
allow the inclusion of more verified data from European sites, and therein
increase the robustness of the study. The Board does not expect this to have
any impact on the Company's recently outlined commercialisation pathway and
the Company remains on track to present results to the clinical community at
ATC (American Transplant Congress) in early June, as planned. Verici Dx
believes it will be able to meet its launch plans within this year, as
expected.

 

All the data from the validation study currently remains "blinded" and
therefore the Company has not yet had access to the performance analysis of
the study.

 

The reason for this decision is due to a delay in compliance visits from the
Company's European study sites. The inclusion of their data is significant as
it contributes to ensuring an evenly distributed study population across all
participating sites. This is an important aspect to ensure the robustness of
the study for commercial launch. Unlike the US sites, where compliance
monitoring can be undertaken remotely, the sites in Italy, France, and Spain
require onsite in-person monitoring, which has recently been hampered by
restrictions due to COVID-19, hence the delay in inclusion of their data.

 

Sara Barrington, Chief Executive Officer, Verici Dx, said: "Our timelines are
such that we have the scope to make a positive strategic choice to increase
the robustness of the study and ensure strong representation from our European
partners, as we initially intended, without impacting our commercial
timelines. Importantly the study data remain blinded, and this decision has
been made in line with the original study design for geographic diversity,
with the added benefit of increasing the total number of patients in the
study. We remain on track to present to the clinical community at ATC in early
June, as planned, with Verici Dx on course to deliver on the launch plans for
our two lead products by the year-end of the year."

 

 

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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