REG - Verici Dx PLC - Successful clinical validation of Clarava™

Verici DxAnnouncement

03/07/2023 07:00

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RNS Number : 6542E  Verici Dx PLC  03 July 2023

3 July 2023

 

Verici Dx plc

("Verici Dx" or the "Company")

 

Successful validation of Clarava™ from an international clinical study

 

Clarava™, a first-in-class pre-transplant prognostic test for risk of early
kidney rejection,

On track for US commercial launch by end of 2023

 

Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for
organ transplant, announces successful validation results from its
prospective, blinded, international multi-centre clinical validation study for
Clarava™. Clarava™, is the first pre-transplant prognostic test to enable
measurement of a patient's immune response to assess the risk of early kidney
graft rejection. The validation study represents a significant demonstration
of Clarava™ as a predictive test capable of informing a clear, actionable
response from clinicians for an estimated 65,000 eligible patients on an
annual basis.

 

Verici Dx is on track to commence the initial US commercial launch of
Clarava™ before the end of 2023. The Company has received a preliminary
Medicare gapfill median rate of $2,650 for Clarava™ from the Centers for
Medicare & Medicaid Services ("CMS").(1)

 

"There is a desperate global need for an effective, personalised
pre-transplant test that can identify the risk of kidney transplant rejection
to inform treatment decisions. The suboptimal dosing of immunosuppressants can
have detrimental consequences for patients and create additional, unnecessary
healthcare costs. Clarava™ has the potential to transform kidney transplant
treatment protocols and improve outcomes for patients," said Dr. Lorenzo
Gallon, Medical Director of the Translational Medicine Programme, the Director
of International Relations and the Director of the Renal Transplant Fellowship
at Northwestern University, Chair of the Verici Dx Science Advisory Board and
Non-Executive Director of the Company.

 

The Clarava™ study, which included a broad and diverse group of 122 patients
preparing to receive a kidney transplant and a range of rejection outcomes
across 13 centres, demonstrated a statistically significant result with a
sensitivity of 78% and specificity of 64%, identifying patients that are at
increased risk for a kidney rejection event in the critical first 60 to 90
days post-transplant, after receiving a kidney from a deceased donor ("DD").
Study data analysis of the clinical performance of Clarava™ demonstrated
differentiation of high-risk and low-risk patient groups, determining that
patients of high risk were approximately six times more likely to have a
rejection than those of low risk. This represents a significant demonstration
of Clarava™ as a predictive test capable of informing for a clear,
actionable response from clinicians. Whilst DDs provide the majority of kidney
transplants, the Company will be also exploring further samples drawn from
Living Donor (LD) transplant recipients, in addition to assessing the
anticipated combination of using our pre-transplant test, Clarava™ in
conjunction with our post-transplant test, Tutivia™.

 

Clarava™ is the only pre-transplant test of its kind that can risk stratify
patients based on their likely immune response to a transplanted organ. This
allows clinicians to identify patients most likely to require increased
monitoring, including adjustments in the type, dose, and duration of
immunosuppressive agents. Existing approaches to assess rejection risk are
standardized and typically based on the recipient's race, age, previous
transplant history and whether they have antibodies against common donor
antigens. As reported, the Clarava™ personalized risk assessment is
especially important for the expanding DD transplant population.

 

Sara Barrington, CEO of Verici Dx, said: "This validation for Clarava is the
second successful product to emerge from the Company's suite of prognostic RNA
signature tests and further validates our underlying technology platform. With
Tutivia™ commercially launched as a measure for post-transplant rejection
risk, the addition of Clarava™ as a pre-transplant test is a significant
milestone in our strategy of building a complementary suite of ground-breaking
products that offer end-to-end testing for kidney transplant patients and
their clinicians, to help personalise care and transform outcomes."

Verici Dx is on track to commence the initial US commercial launch of
Clarava™ before the end of the year to support the utility case studies and
will be offered in conjunction with its other lead product, Tutivia™, which
is already available in the US. The Company intends to leverage its existing
internal resources and growing network of early adopters to develop the
clinical positioning and marketing collateral for both products.

( )

(Notes)

(1) The proposed CMS rate is currently open for public comment before it is
finalised later this year. Following finalisation, the price in the Clinical
Laboratory Fee Schedule ("CLFS") is valid for a period of three years from 1
January 2024, after which it is subject to further review.

 

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: +44 20 7496 3000
 Aubrey Powell / Sam Butcher

 Walbrook PR Limited                                      Tel: +44 20 7933 8780 or vericidx@walbrookpr.com
                                                          (mailto:renalytix@walbrookpr.com)
 Paul McManus / Stephanie Cuthbert /                      Mob: +44 7980 541 893 / +44 7796 794 663 /

 Sam Allen                                                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.

 

Verici Dx's two lead products are Tutivia™, a post-transplant test focused
upon acute cellular rejection, including sub-clinical rejection and
Clarava™, a pre-transplant prognosis test for the risk of early acute
rejection. These products seek to measure how a patient is likely to respond,
and is responding, to a kidney transplant. These products are underpinned by
extensive patented and published scientific research from the leading Mount
Sinai Medical Center, for which the Company holds an exclusive worldwide
licence.

 

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