TIDMVRCI
RNS Number : 7803T
Verici Dx PLC
22 March 2023
Verici Dx plc
("Verici Dx" or the "Company")
Operational Update
First revenues from Tutivia (TM) following full commercial
launch
Verici Dx plc (AIM: VRCI), a developer of advanced clinical
diagnostics for organ transplant, provides an update on its
operational progress made since the release of its interim results
in September 2022.
Verici Dx continues to execute the commercial introduction of
Tutivia(TM), the Company's first product for kidney transplant
rejection, with first revenues in FY 2023 and is exploring
strategic options to increase sales distribution and launch its
second lead product, Clarava(TM) by the end of the year. The
Company retains sufficient funding to achieve further key
milestones in 2023 and the first half of 2024, which will support
commercial adoption including the publication of additional data
and obtaining both Medicare and private payor pricing and
coverage.
Data continues to support product differentiation and
competitive advantages
Following a robust validation trial using a varied, 'all-comers'
patient population in a clinical setting, Tutivia(TM), a
post-transplant prognostic test for the assessment of risk of acute
kidney rejection , was pilot-launched in December 2022 ahead of its
full commercial launch in January 2023. The validation trial data
showed a positive predictive value (PPV) of 60%, over three times
that was achieved by the closest comparative product in the market
when used in the same context, establishing a new industry
standard. Additionally, study data analysis of the clinical
performance of Tutivia(TM) demonstrated a 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 Tutivia(TM) as a predictive test capable of
informing a clear, actionable response from clinicians. The
Directors believe that no other comparable products have been
validated to this degree.
Tutivia(TM) also has competitive advantages, as it can be run as
early as the first-week post-transplant, earlier than any other
test. Tutivia(TM) enables clinicians to act proactively, rather
than reactively, to rejection events, as well as not being
confounded by other kidney health complications (such as the BK
virus), which need an alternative therapy protocol. This is because
Tutivia(TM) identifies RNA signatures that are specific to acute
rejection, as opposed to other tests that detect evidence of damage
that may not necessarily be caused by rejection alone.
In addition, following the positive initial data announced in
September 2022 on Clarava(TM), the Company's pre-transplant
prognostic test, the Company chose to expand its validation trial
for this lead product for a further six months. This decision was
taken to strengthen the publication appeal of the trial and
demonstrate a statistically robust and clinically compelling case
in support of the commercial rollout and adoption of the test. The
full readout from this trial is expected in Q2 2023, with the
initial launch expected before the end of the year.
Strong progress on rollout strategy
In line with its strategic plan, the Company is working with
three leading US transplant centres in the Tutivia (TM) commercial
launch and is supporting them with the adoption and integration of
the test into the current clinical pathway, to encourage consistent
and recurring utilisation. This is providing a valuable foundation
for Verici Dx to make Tutivia(TM) as simple as possible for
clinicians to use and interpret.
Following the successful progression of the Company's laboratory
registration status to Compliance Certification by the Centers for
Medicare & Medicaid ('CMS'), allowing its commercial operation
for samples received from patients in 45 US states, Verici Dx is
ready to build on the initial rollout activity over the course of
2023. Medicare and Medicaid account nationally for about 65% of all
transplant patients and the Company is focused the initial rollout
of the test where the proportion of Medicare patients is higher
than the national average. To further drive adoption the Company
has addressed the pricing and coverage determinations under
Medicare. This is administered by the MolDx region of Palmetto
given the Company's laboratory is based in Tennesse. The Company
submitted its pricing proposal in Q1 2023 and expects to get the
MolDx pricing recommendation by the end of Q2 2023. The Company is
currently preparing its submission for Medicare insurance
reimbursement coverage, under the Local Coverage Determination
(LCD) offered in Palmetto and a coverage determination is expected
later this year. Registration for Medicaid has been approved in
three states and submitted in a further 11 states as well as with
BlueCross Blue Shield of Tennessee, the largest health benefit plan
company in the state.
Prudent cash management and execution
As of 31 December 2022, the Company had a cash balance of
$9.81m. The Company has taken headcount reduction and clinical
trial cost containment steps in recent months and, as a result, has
extended the current cash runway to last until mid-2024. The
Company is focused on early revenue generation during the first
half of this year and will seek to extend and broaden its revenue
streams from additional centres in the second half of 2023.
The Company expects to report its preliminary results for the
year ended 31 December 2022 by the end of April 2023.
Sara Barrington, CEO of Verici Dx, said:
"We have continued to make significant progress in executing our
strategy, resulting in the full commercial launch of Tutivia (TM)
in January, with Clarava's(TM) initial launch expected before the
end of this year.
"We achieved our internal target of attracting three key,
leading US transplant sites as early adopters for Tutivia (TM), a
critical step that is enabling us to demonstrate the adoption and
integration process for clinicians.
"Looking ahead to the rest of the year, we plan to accelerate
the rollout of Tutivia (TM) to other major transplant sites
throughout the US, and to secure pricing and health insurance
coverage for this lead product. For Clarava (TM) , we expect to
report validation shortly and to initiate its initial launch before
the end of the year, which will support the collation of further
evidence to enable a positive coverage determination. These pivotal
milestones will help refine our market positioning and further
accelerate commercial uptake of both of our lead products. Verici
Dx looks forward to reporting on its further progress."
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 Clarava(TM), a pre-transplant
prognosis test for the risk of early acute rejection, and
Tutivia(TM), a post-transplant test focused upon acute cellular
rejection, including sub-clinical 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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