Verici Dx Regulatory News (VRCI)

Verici Dx plc

("Verici Dx" or the "Company") 

Update on Local Coverage Determination and Trading

Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces that it is planning to submit supplemental information to Medicare in support of a coverage determination for its TutiviaTM test and expects this process will continue into H1 2025 rather than the anticipated end of FY24. As such, the Company will now recognise TutiviaTM revenues from this year in FY25. The updated timeline has no effect on the Company's cash position at year end which we expect to be in line with market expectations.

The TutiviaTM test has been well received by clinicians. Adoption of innovative products, however, is sensitive to establishing comprehensive insurance coverage and the lack of coverage has slowed the pace of adoption. We remain pleased with the initial TutiviaTM test ordering, the levels of repeat ordering, and expect volumes to accelerate as insurance coverage is established in 2025.

Dr. Zahraa Hajjiri, Assistant Professor of Medicine, Department of Internal Medicine, Division of Nephrology, Transplant Nephrology, Medical Director Transplant Nephrology, said: 

"Validated biomarkers for all post-transplant patients early post-transplant, including those experiencing slow allograft function and delayed allograft function are currently limited. As early adopters of this test, we have been exceedingly satisfied with its outcomes and high reliability. We are in the process of integrating it into our protocol for delayed graft function and biomarker assessment, anticipating a significant surge in its utilization."

The Company's partnerships remain strong, and licensing revenues remain on track. The services business continues to generate collaborations, with contracts signed to date now anticipated to generate revenue in 2025 rather than the last quarter of 2024.

As at 30 September 2024, the Company had $6.1 million in cash. Verici Dx has continued to demonstrate a disciplined approach to cost control and anticipates that the year-end cash balances will be in line with current market expectations.

Sara Barrington, CEO of Verici Dx, said:

"Local coverage determination is important to our commercial strategy, and we are actively working with the assessment team to expedite the approval process. While this delay pushes back our short-term revenue expectations, our long-term outlook remains positive as we continue with the adoption of TutiviaTM."

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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.