Verici DX Logo

2022 Annual Results

Successful transition from a research to commercial-stage company

Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces its audited final results for the year ended 31 December 2022 and provides a progress update since year end.

Strategic progress (including post-period end)

  • Achieved full commercial launch of Tutivia™, the Company’s first product for the detection of acute
    kidney transplant rejection, in January 2023, leading to first revenues being recognised in FY 2023.
  • Expanded its validation trial on Clarava™, the Company's pre-transplant prognostic test, for a further six
    months following positive initial data announced in September 2022. This decision was taken to
    strengthen the publication appeal of the trial and demonstrate a statistically robust and clinically
    compelling case in support of the commercial rollout and adoption of the test. The full readout from this
    trial remains on track to be announced by the end of June 2023, in line with previous guidance.
  • Patient enrolment for the multi-centre clinical validation study of our third product, ProtegaTM, was
    completed in the first quarter of 2023, assessing long-term outcomes for kidney transplant patients.
  • Extended cash runway until mid-2024; the Company has retained sufficient funding to achieve further
    key milestones in 2023 and the first half of 2024 which will support commercial adoption, including the
    publication of additional data and obtaining both Medicare and private payor pricing and coverage. A
    further commercial and operational update will be provided alongside the Clarava™ data readout.

Operational highlights (including post-period end)

  • Announced positive results from the Tutivia™ clinical validation study in June 2022, for the detection of
    acute rejection following a kidney transplant.
  • Granted CPT® Proprietary Laboratory Analyses ("PLA") codes for Clarava™ and Tutivia™ tests by the
    American Medical Association ("AMA"), providing the basis for coding and payment within the US
    healthcare market.
  • In May 2023, a gapfill median rate of $2,650 was proposed for Tutivia™ for kidney transplant rejection
    by the Centers for Medicare & Medicaid Services (“CMS”) in line with the Company’s application.
  • Obtained Medicaid approvals in 14 States and a further 11 States are pending.
  • Two key patents granted in the United States underpinning Verici Dx’s products.\
  • Achieved CLIA Certificate of Compliance for laboratory in Nashville, TN, USA, a key requirement to
    obtaining insurance reimbursement coverage under Medicare and allowing for expanded commercial
    launch of Tutivia™, in 45 US states.
  • Completed analytical validation for Clarava™ and Tutivia™ in February 2022, an essential element of
    defining the performance characteristics and platform capabilities of in vitro diagnostic assays and a key
    milestone towards commercialisation.
  • Announced a collaboration with Illumina, Inc., for early access to the Illumina Connected Analytics (ICA)
    platform to expedite the operational launch of data analysis processing and predictive artificial
    intelligence component of Verici’s products in due course.

Financial highlights

  • Adjusted EBITDA1 loss of $10.5m (2021: loss of $7.1m).
  • Cash balance at 31 December 2022 of $9.81m (2021: $10.3m).
  • Raised gross proceeds of £10.0m in March 2022 via Placing and Subscription.
  • Cash runway extended to mid-2024.

Commenting on the performance and outlook, Sara Barrington, Chief Executive Officer, said:

“2022 was a transformational year for Verici Dx; we began the year as an R&D-stage company, and have now
commercially launched our first product, Tutivia™, following pleasing validation study results.
“We are well placed to deliver further progress against our strategy in 2023, building on the initial rollout of
Tutivia™ and we remain on track to announce the data read-out from the extended Clarava™ trial by the end
of June. In addition, we are taking further steps towards reimbursement that will help accelerate commercial
uptake of our lead products.”

Investor briefing

As previously announced, an investor meeting covering the FY22 financial results will be provided following
the data read-out from the extended Clarava™ trial, expected to be announced by the end of June.



Sara Barrington, CEO Julian Baines, Chairman Via Walbrook PR

N+1 Singer (Nominated Adviser & Broker) Aubrey Powell / Kailey Aliyar / Tom Salvesen

Tel: 020 7496 3000

Walbrook PR Limited Paul McManus / Sam Allen

Tel: 020 7933 8780 or Mob: 07980 541 893 / 07748 651 727

Sara Barrington, CEO
Julian Baines, Chairman
Via Walbrook PR

N+1 Singer (Nominated Adviser & Broker)
Aubrey Powell / Kailey Aliyar / Tom Salvesen

Tel: 020 7496 3000

Walbrook PR Limited
Paul McManus / Sam Allen

Tel: 020 7933 8780 or
Mob: 07980 541 893 / 07748 651 727

About Verici Dx plc

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.

Verici Dx's two lead products are Tutivia™, a post-transplant test focused upon acute cellular rejection, including sub-clinical rejection and Clarava™, a pre-transplant prognosis test for the risk of early acute rejection. These products seek to measure how a patient is likely to respond, and is responding, to a kidney transplant. These products are underpinned by extensive patented and published scientific research from the leading Mount Sinai Medical Center, for which the Company holds an exclusive worldwide licence.

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 or visit

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.