RCS - Verici Dx PLC - CLIA Certificate of Compliance update

Verici DxAnnouncement

20/07/2023 07:00

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RNS Number : 5832G  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
(https://verici-dx-plc.flint-platform.com/regulatory-news/33076) , 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™, for the detection of  acute
rejection in kidney post-transplant patients, in January 2023 and recently
announced the successful validation of Clarava™, 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™
and Clarava™ ."

 

 

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.

 

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