VERICI DX PLC

Management Reports • Apr 10, 2025

National Storage Mechanism | Additional information

RNS Number : 4852E

Verici Dx PLC

10 April 2025

Verici Dx plc

("Verici Dx" or the "Company") 

Verici Receives Medicare Coverage for Tutivia

Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant is pleased to announce a positive Technical Assessment by Palmetto GBA, a Medicare Administrative Contractor (MAC) that assesses diagnostic technologies through its Molecular Diagnostic Services Program (MolDX) allowing for Medicare coverage of its Tutivia™ assay, a diagnostic test for acute rejection.  Patients with a high-risk Tutivia™ score are nearly six times as likely to experience acute rejection over those with low-risk results.  Tutivia already has a Medicare code (032OU) and price of $2,650.

As previously announced, in Q1 2025 Verici Dx had already seen a strong acceleration in its highest Tutivia™ testing order rate of 292 tests. This represents a significant 68% increase in the testing order rate over the previous quarter (Q4 2024) and compares to a total test ordering figure of 334 for FY 2024. This is a highly encouraging ramp up in adoption and test ordering and the Company expects continued growth in Tutivia™ with the ability of Verici to scale testing of Tutivia™ through its own direct to physician sales.  With the positive coverage determination now received, the Company is now able to recognise revenues.

Tutivia ™ is the Company's post kidney transplant blood test that reports the patient's risk of all forms of acute rejection, including borderline, T cell-mediated, and antibody-mediated rejections. The test therefore supports clinical care for the estimated c.100,000 global patients who undergo kidney transplant procedures annually. Tutivia TM delivers a significant improvement in biomarker offerings, particularly early post-transplant when patient management can be complex and other biomarkers are contraindicated or less informative.   Tutivia's™ has an important role in helping improve patient outcomes with significant implications for clinical care, providing relevant information for immunosuppression management and supporting clinical decision making with regard to kidney biopsy.

Following a review of clinical validity, analytical validity, and clinical utility, MolDX determined that Tutivia ™ has met the criteria for coverage under LCD L38568, MolDX: Molecular Testing for Solid Organ Allograft Rejection for renal transplant patients. The MolDX coverage decision signifies that Tutivia ™ meets requirements for Medicare coverage and will support broader access for renal transplant patients.

Commenting on the approval, Sara Barrington, CEO of Verici Dx, said :

" The achievement of this key milestone reflects the exciting work that is ongoing at Verici and the quality of its science. Securing a positive MolDX coverage decision will improve patient access to the Tutivia ™ assay, advancing both availability and adoption. With this decision, we hope that more patients can benefit from a significant step forward in enhancing diagnostic accuracy and post-transplant patient care. With Tutivia ™ already seeing strong positive feedback from early adopters and the accelerated sales already coming through, we look forward to continued success in a commercial setting."

Enquiries:

Verici Dx	www.v ericidx .com
Sara Barrington, CEO	[email protected]
Julian Baines, Chairman
Singer Capital Markets (Nominated Adviser & Broker)	Tel: +44 20 7496 3000
Phil Davies / Sam Butcher

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, including through 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.

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact [email protected] or visit www.rns.com.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our Privacy Policy.

END

UPDGPUPUCUPAUMU