Verici Dx PLC CLIA Certificate of Compliance (5972R)
02 März 2023 - 8:00AM
UK Regulatory
TIDMVRCI
RNS Number : 5972R
Verici Dx PLC
02 March 2023
Verici Dx plc
("Verici Dx" or the "Company")
Verici Dx achieves CLIA Certificate of Compliance for full
commercial launch of Tutivia(TM)
Successful CMS review and inspection solidify commercial
positioning and
represents a major milestone toward US Medicare
reimbursement
Verici Dx plc (AIM: VRCI), a developer of advanced clinical
diagnostics for organ transplant, announces that it has
successfully progressed its Registration status to Compliance
Certification by the Centers for Medicare & Medicaid ("CMS')
for its commercial clinical operations to 45 US states . This
follows the inspection by CMS of the Company's US clinical
laboratory based at the Innovation Park in Franklin, Tennessee.
The Company now intends to expand commercialisation of its
advanced kidney transplant service offerings including Tutivia(TM).
This milestone of certification is also a key requirement to
obtaining insurance reimbursement coverage under Medicare under the
Local Coverage Determination application being submitted this
year.
The Company launched its first product, Tutivia(TM), for the
detection of early acute rejection in kidney post-transplant
patients, in January 2023. This CLIA certification increases the
ease of ordering a Tutivia(TM) test from laboratories at transplant
medical centres and provides further validation of Verici's tests
and services for transplant clinicians across the United
States.
The Company will now proceed with its plan towards full
accreditation in the remaining five states, including New York,
which have further compliance requirements .
The CLIA certification further exemplifies Verici's commitment
to a quality-focused approach to providing advanced kidney
transplant diagnostics services to clinicians and patients in
need.
Sara Barrington, CEO of Verici Dx, said:
" This milestone is an enabling step in our ability to offer our
two leading diagnostic tests, Tutivia (TM) and Clarava(TM), on a
national basis to patients and their clinicians. We are well
positioned to achieve additional milestones and progress commercial
initiatives in 2023 that will support our growth in the United
States."
Verici Dx will give further progress and strategy updates later
this month .
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.
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