REG - Verici Dx PLC - Verici Receives Medicare Coverage for Tutivia

Verici DxAnnouncement

10/04/2025 08:15

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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 (http://www.vericidx.com) ericidx (http://www.vericidx.com) .com
                                                          (http://www.vericidx.com)
 Sara Barrington, CEO                                     investors@vericidx.com
 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 (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, 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.

 

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