Verici Dx (VRCI ) said it has obtained a “major milestone” certification which will authorise it to initiate commercial operations as a diagnostic lab in Tennessee in the United States. 

The Group, which develops clinical diagnostics for organ transplants, has obtained a Clinical Laboratory Improvement Amendments (CLIA) Certification of Registration under the Centers for Medicare & Medicaid Services (CMS) for its newly established US clinical laboratory. 

The lab at the Innovation Park in Franklin, Tennessee, which was signed for in April, is located in the Palmetto region, one of the largest Medicare administrative contractors in the US.  

At the time, the new space marked the first step towards Verici Dx achieving the necessary CLIA approvals for its commercial launch of its leading products, Clarava™ and Tuteva™.  

Back in January 2021, Verici unveiled plans to accelerate a CLIA approval strategy in otfrt to bring forward this commercial launch with the appointment of David Schultenover as Vice President of Quality and Regulatory who is to project manage this key objective for 2021.  

The Group’s Clarava™ assay is a pre-transplant prognosis test for the risk of early acute rejection, while Tuteva™ is a post-transplant diagnostic focused upon acute cellular rejection.   

These technologies are underpinned by extensive patented and published scientific research from Mount Sinai Medical Center for which Verici Dx holds an exclusive worldwide licence. 

Verici requires a CLIA-certified lab to be able to offer the diagnostic products to clinicians as a lab developed test and it now expects approvals to be cleared by the end of this year.  Verici Dx expects to commercially launch its commercial products Clarava™ and Tuteva™, in 2022. 

Verici Dx said the issuance of the CLIA represents a milestone in the steps toward seeking a coverage determination through the MolDx Program administered by Palmetto GBA. 

Palmetto GBA, which operates as the regional Medicare Administrative Contractor (MAC) of the Centers for Medicare & Medicaid Services, is responsible for services performed in laboratories located in the State of Tennessee and is also one of the largest MACs in the US. 

Michael J. Donovan, Chief Medical Officer of Verici Dx, said: "CLIA certification is the keystone of our strategy that serves to broaden diagnostic testing in the near term for kidney transplant patients. This Certificate of Registration is a key milestone in the CLIA approval pathway essential for commercial launch of the Company's two lead products.” 

He added, “Subject to successful conclusion of our validation studies, having a CLIA-certified lab will allow us to aid clinicians by using accurate, data-driven and non-invasive detection, to support their clinical decisions and ultimately improve kidney graft health for the tens of thousands of patients who undergo kidney transplant each year.” 

View from Vox 

Last week, Verici Dx expanded the clinical validation of two of its lead assets by initiating its first European clinical validation trial site at the Sant'Orsola Polyclinic Hospital in Bologna.  

The Company will work in partnership with Professor Gaetano La Manna, Director of the Specialization School in Nephrology and the Dialysis and Transplant Unit in Bologna, Italy.  

The Company told investors that this recent work alongside Prof. Gaetano La Manna forms part of its efforts to expand its clinical development and validation beyond North America.   

Verici Dx unveiled its collaboration with three leading US centres for clinical validation trial of its lead products back in March 2021 and has subsequently opened 2 more US centres.  

To date, enrolment is on target for completion of the Clarava and Tuteva validation study by the end of 2021 with data expected to be published ‘as soon as practicably possible’ in 2022.  

Its efforts to accelerate the use of its organ transplant products comes at a time when the landscape of solid organ transplantation has dramatically changed as a result of COVID-19.   

While developing, trialling and obtaining the necessary regulatory authorisations before launching medical technologies can be a lengthy process, Verici said it is focused on compressing these timescales with the aim to commercialise its kidney tests in 2022.   

Shares in Verici Dx have increased by over 30% in value since the beginning of 2021. The stock was trading 1.97% higher this morning at 77.5p following the announcement.  

Reasons to  VRCI

Verici Dx is focused on developing and commercialising tests to understand how a patient will and is responding to organ transplant, with an initial focus on kidney transplants.   

Leading IP  

The Company’s work is underpinned by extensive scientific research into the recipient's immune phenotype and how that impacts on acute rejection, chronic injury and ultimately failure of the transplant.  

Meanwhile, the company’s immuno-profile signatures also inform clinicians as to the optimal strategy for immunosuppressive and other therapies for the most successful treatment to ensure graft acceptance with the least amount of side effects.  

Verici Dx was admitted to trading on AIM on 3 November 2020, with the company also raising £12.05m through an oversubscribed fundraising, to primarily fund the development and commercialisation of its two leading clinical products in the kidney transplant space.   

Significant Market Opportunity >$600m p.a.  

The waiting list for transplants is significant at around 300,000 globally with US and European governments calling for an acceleration in the number of transplants undertaken each year.   

Globally, there are approximately 95,000 transplants per annum, of which approximately 24,000 and 25,000 are performed in the US and Europe respectively.    

In the US the average cost of a transplant is $0.44m per transplant and the average annual cost of dialysis is around $0.09m, with patients faced with being on dialysis from 3 to 5 years.    

Positive Development Newsflow  

Verici aims to commence a multi-centre validation study for each product in 4Q20, with studies expected to conclude in 4Q21. Clarava and Tuteva are then expected to be offered as Lab Developed Tests with regulatory approval with first revenues expected during 2022.   

Verici expects supportive news flow throughout 2021 on commercial partnerships, regulatory news, reimbursement and results from test development programmes. Once approved, it aims to accelerate reimbursement coverage ahead of full clinical utility data in 4Q22.   

Last month, Verici expanded the scope of an existing licence agreement to include an additional patent filing related to the analysis of gene expression in a blood-based test (liquid biopsy) to predict risk of fibrosis (chronic kidney graft damage) and rejection of the graft.  

The development of a product that can predict risk of fibrosis and rejection using Verici’s core technological approach would extend its portfolio across the full course of a patient's transplant journey and complement its two in vitro diagnostic assays, Clarava and Tuteva.  

The development of a product that can predict the risk of long-term graft failure, alongside our flagship products Clarava™ and Tuteva™, would establish an end-to-end solution for clinicians seeking to understand how a patient will and is responding to organ transplant.   

There is a critical need for more personalised diagnostic information within transplant care, and in particular technologies informing earlier interventions with anti-fibrotic therapies in advance of irreversible organ damage,” commented Sara Barrington, CEO of the licence.  

Verici said it will provide more information on its development and commercialisation plans in its results for the financial year ended 31 December 2020, which it expects to release in April.  

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