Verici (VRC ), which develops clinical diagnostics for organ transplants, signed the lease for the lab within the Palmetto region, one of the largest Medicare administrative contractors in the United States, for CMS (Center for Medicare and Medicaid Services) Medicare governance.
Verici said the new space, which will be situated at the Innovation Park in Franklin, Tennessee, marks the first step towards the Company 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.
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.
The Company explained to investors that the Center for Medicare and Medicaid Services (“CMS”) regulates laboratory testing in the US through the CLIA regime, which requires all clinical labs to be certified before they can accept human samples for diagnostic testing.
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.
David Schultenover, VP Quality and Regulatory Affairs at Verici Dx, commented, "I joined the Company in January this year to help expedite the CLIA approval strategy and signing the lease to this space marks the first step towards achieving these CLIA approvals necessary for commercial launch of the Company's leading products, ClaravaTM and TutevaTM.”
He added, “Innovation Park is an ideal location for the Company to establish operations and we are delighted with the quality of the premises which are well suited for our needs."
View from Vox
Developing, trialling and obtaining the necessary regulatory authorisations before launching next generation, medical technology can be a lengthy process. However, the breakthrough immunodiagnostics firm is aiming to compress these timescales without compromising quality in order to commercialise its revolutionary new kidney transplant tests in 2022.
In a brief update today, Verici said that it has signed a lease relating to a CLIA-certified lab in Tennessee, with the aim of offering these products to clinicians by year-end.
Shares in the Company have increased by over 15% in value since the beginning of the year. The stock was trading 3.65% lower this morning at 66p 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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