CLIA Certificate of Compliance

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 ericidx .com
Sara Barrington, CEO	Via Walbrook PR
Julian Baines, Chairman
Singer Capital Markets (Nominated Adviser & Broker)	Tel: [phone]
Aubrey Powell / Sam Butcher
Walbrook PR Limited	Tel: [phone] or  [e-mail]
Paul McManus / Stephanie Cuthbert / Sam Allen	Mob: [phone] / 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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