REG - Verici Dx PLC - Positive results for Clarava from validation study

Verici DxAnnouncement

06/09/2022 07:00

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RNS Number : 3478Y  Verici Dx PLC  06 September 2022

Verici Dx plc

("Verici Dx" or the "Company")

 

Positive results for Clarava™ from blinded multi-centre clinical validation
study

 

Data validates Clarava's ability to identify patients likely to experience
future kidney transplant rejection

 

Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for
organ transplant, announces the successful outcomes from its blinded,
international, multi-centre validation study for Clarava™, the Company's
pre-transplant blood-based prognostic test for the risk of early acute kidney
transplant rejection.

 

Utilising a diverse validation population from 14 international transplant
sites, the initial results of the validation study amongst the US kidney
transplant patients followed up to date show that the Clarava™ diagnostic,
which uses next-generation RNA sequencing, is an effective tool to identify
patients likely to experience a future transplant rejection event prior to
their surgery.

 

Clarava™ represents a novel pre-transplant approach to characterising a
patient's immune-profile using their RNA signature. This is expected to have
wide-ranging implications regarding treatment plans for each patient ahead of
transplant, post-operatively and in terms of monitoring patient response. The
Directors believe that the available data on Clarava™ positions it as a
viable and compelling product for a broader patient population and
commercialisation, as it has no directly competing products. These initial
results from the Clarava™ validation study therefore mark a further,
important step toward clinical acceptance and commercialisation of the test.

 

To generate broad clinical acceptance within the diverse international
transplant community, Verici Dx is extending enrolment in its ongoing clinical
validation study for an additional six-month period, using its existing
network of 14 international transplant centres across Europe as well as the
US. The expansion of the Clarava™ validation cohort is designed to enrich
the utility data for the assay and support a statistically robust and
clinically meaningful case for its adoption in due course.

 

Sara Barrington, CEO, Verici Dx, said: "This new validating data demonstrates
that Clarava™ can have a significant impact for transplant clinicians
understanding of which patients could experience early acute rejection,
pre-surgery. As a result, clinicians can make better decisions in advance that
can help drive better outcomes post-transplant."

 

The extension of the validation study has no material impact on the Company's
cash resources and runway, as the Clarava™ validation work is leveraging the
ongoing, budgeted clinical validation study for Verici Dx's third product,
Protega™, as each patient's sample can be used for multiple tests. Further
updates on the Company's progress will be provided shortly in its interim
results announcement, which is due to be released on 7 September 2022.

 

The information contained within this announcement is deemed by the Company to
constitute inside information

as stipulated under the Market Abuse Regulations (EU) No. 596/2014 (as
implemented into English law) ("MAR").

With the publication of this announcement via a Regulatory Information
Service, this inside information is now considered to be in the public domain.
The Directors named below take responsibility for the release of this
information.

 

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 / Sam Butcher

 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.

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