REG - Verici Dx PLC - CLIA Certificate of Compliance

Verici DxAnnouncement

02/03/2023 07:00

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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™

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™. 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™, 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™ 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™ and Clarava™, 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 (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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