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."