Verici Dx PLC CLIA Certificate of Compliance update
20 July 2023 - 4:00PM
RNS Non-Regulatory
TIDMVRCI
Verici Dx PLC
20 July 2023
Verici Dx plc
("Verici Dx" or the "Company")
CLIA Certificate of Compliance update
US clinical laboratory now fully accredited in 49 states
Verici Dx plc (AIM: VRCI), a developer of advanced clinical
diagnostics for organ transplant, announces that further to the RNS
dated 2 March 2023 , the Company has received compliance
authorisation for the operation of its commercial clinical
laboratory testing in respect of samples from an additional four US
states, including the important addition of California , with the
Company laboratory now fully accredited in a total of 49
states.
Together with the CLIA certification previously obtained from
the Centers for Medicare & Medicaid ("CMS"), clinicians at
transplant medical centres in these additional states are now
enabled to order Verici Dx's transplant tests, expanding the
Company's commercial reach. California has consistently accounted
for over 10 per cent. of the national US volume of kidney
transplant procedures in each year since 1998 and has conducted the
highest volume of transplants by any state each year over the same
period.
Verici Dx launched its first product, Tutivia(TM), for the
detection of acute rejection in kidney post-transplant patients, in
January 2023 and recently announced the successful validation of
Clarava(TM), a first-in-class pre-transplant prognosis test for the
risk of early acute rejection in deceased donor recipients, which
it expects to launch later this year. The additional state
accreditations provide further validation of Verici Dx's clinical
laboratory for its tests to be used by transplant clinicians across
the US.
The Company continues to work towards full accreditation in the
final state of New York, which has its own compliance requirements
.
The CLIA certification and additional state approvals further
exemplify Verici's commitment to a quality-focused approach to
providing advanced kidney transplant diagnostic services to
clinicians and patients in need.
Sara Barrington, CEO of Verici Dx, said: " This is another
important step in our strategy, expanding our commercial reach and
making it easier for clinicians to order our tests helping to drive
the adoption of both Tutivia(TM) and Clarava(TM) ."
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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END
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