REG - Verici Dx PLC - Clarava™ and Tuteva™ complete testing requirements

Verici DxAnnouncement

06/01/2022 07:00

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RNS Number : 5699X  Verici Dx PLC  06 January 2022

Verici Dx plc

("Verici Dx" or the "Company")

 

Clarava™ and Tuteva™ complete testing requirements for completion of
clinical validation study

 

Primary data analysis of two lead products on track for Q1 2022 read-out

 

Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for
organ transplant, announces that its two leading products have completed the
testing requirements of the multi-centre validation study, in line with the
Company's expectations to have done so by the end of 2021. Reaching the
clinical endpoints of the study means that, for both products, sufficient
numbers of participants have completed the required follow-up to outcomes
assessment, including biopsy findings, which are required for the full data
analysis and clinical study report to be conducted in Q1 2022, as per the
Company's targets.

 

The Company's two leading products aim to understand how a patient will and is
responding to kidney transplantation:

 

·    Clarava™ is a pre-transplant prognosis test for the risk of early
acute rejection; and

·    Tuteva™ is a post-transplant test focused upon acute cellular
rejection, including sub-clinical rejection as correlates to histopathology
findings.

 

Verici Dx has partnered with fourteen leading US, Australian and EU centres in
its collaborative, multi-centre clinical validation study. As previously
announced, patient enrolment for both Clarava and Tuteva performance
evaluation was completed ahead of schedule in August 2021, and we are grateful
to all of the participating sites and their clinical teams for achieving
this.  The extent of commitment shown by these leading centres is testament
to the recognition of the robust, scientific approach being taken by Verici Dx
to its data gathering and analysis, and to the shared desire to make
much-needed and potentially very significant gains in transplant patient
outcomes.

 

As announced on 11 January 2021, Verici Dx in-licensed additional intellectual
property (IP) relating to gene expression in a blood-based test (liquid
biopsy) to predict the risk of fibrosis or chronic kidney graft damage.  This
is being commercialised under the product name, Protega(TM) and extends the
Verici Dx portfolio across the full transplant patient journey by focusing on
the prognosis of longer-term graft failure. Protega™ augments the Company's
portfolio into an end-to-end transplant testing suite, from pre-transplant and
short-term post-transplant to also include later-stage risk assessment.

 

The current fourteen clinical trial sites participating in the validation
study for Clarava™ and Tuteva™ will continue the enrolment of patients for
an extended period for the validation study of Protega and is expected to
reach target by the end of Q3 next year.  The potential to inform earlier
clinical interventions with treatments such as anti-fibrotic therapies ahead
of irreversible organ damage is another key step to improving transplant
outcomes.

 

Patti Connolly, Executive VP, Product Development of Verici Dx, said: "We are
pleased that both Clarava™ and Tuteva™ have not only exceeded the
enrolment objectives for the clinical validation study in terms of numbers of
sites and participants, but also completed testing in line with our
expectations. This is another step towards the commercialisation of our two
lead products, and we look forward to the data analysis and reporting of key
findings in Q1 2022, with additional analyses to follow.

 

"I'd like to extend Verici Dx's gratitude to all of the kidney transplant
patients participating in our studies as well as thanks to our fourteen
collaborating centres across the US, Australia and EU who have partnered with
us to bring these innovative in vitro diagnostics closer to the clinic. We
look forward to sharing the validation reporting in 2022 as we approach
commercial readiness for our two lead products and continue with validation
for our third product."

 

 

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
 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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