TIDMVRCI
RNS Number : 6542E
Verici Dx PLC
03 July 2023
3 July 2023
Verici Dx plc
("Verici Dx" or the "Company")
Successful validation of Clarava(TM) from an international
clinical study
Clarava(TM), 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(TM). Clarava(TM), 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(TM) 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(TM) before the end of 2023. The Company has
received a preliminary Medicare gapfill median rate of $2,650 for
Clarava(TM) 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(TM)
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(TM) 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(TM) 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(TM) 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(TM) in conjunction with our
post-transplant test, Tutivia(TM).
Clarava(TM) 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(TM) 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 (TM)
commercially launched as a measure for post-transplant rejection
risk, the addition of Clarava (TM) 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(TM) before the end of the year to support the
utility case studies and will be offered in conjunction with its
other lead product, Tutivia(TM), 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 ericidx .com
Sara Barrington, CEO Via Walbrook PR
Julian Baines, Chairman
Singer Capital Markets (Nominated Tel: +44 20 7496 3000
Adviser & Broker)
Aubrey Powell / Sam Butcher
Walbrook PR Limited Tel: +44 20 7933 8780 or vericidx@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
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(TM), a post-transplant
test focused upon acute cellular rejection, including sub-clinical
rejection and Clarava(TM), 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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