Verici Dx accelerates commercial launch
(VRCI ) said it is accelerating its Clinical Laboratory Improvement Amendments (“CLIA”) approval strategy in order to bring forward the commercial launch of its two lead products.
CEO, Sara Barrington said the approval is “an important step” in the commercialisation journey for the Group’s innovative transplant products. She said, “we are pleased to be expanding our management resources to help expedite CLIA approvals for our laboratories."
Verici’s plans will include the appointment of David Schultenover as Vice President of Quality and Regulatory with immediate effect to project manage this key objective for 2021.
The Company said David Schultenover, who is an experienced pharmaceutical and medical device quality control & quality assurance management professional, will be responsible for the delivery of Clinical Laboratory Improvement Amendments (CLIA) laboratory approvals.
"His track record of leading teams that meet and exceed expectations, and his experience in developing and implementing processes and procedures that improve company efficiencies will allow us to ensure we work to accelerate the timelines for opening CLIA laboratories and obtaining CLIA approvals as outlined at IPO,” said Barrington of the appointment.
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.
Although the Centres for Medicare and Medicaid Services has categorised solid organ transplantation as an urgent procedure, the majority of transplant centres in the US have reduced the numbers of kidney transplant procedures in response to the ongoing pandemic.
The Nature Reviews Nephrology wrote that the pandemic “has disrupted transplant referral and listing processes, led to decreases in the numbers of transplant procedures and resulted in changes in practice for pre- and post-transplantation management and follow-up.”
In fact, an analysis of US registry data showed that between 15 March and 30 April 2020 alone, the numbers of deceased donor and live donor kidney transplant procedures were, respectively, 24% and 87% lower than would be expected based on pre-epidemic data.
A 2.2-fold increase in mortality was observed among wait-listed patients in states with the highest COVID-19 burdens. “These statistics demonstrate the devastating effect of the pandemic on patients awaiting kidney transplantation,” said Nature Reviews Nephrology.
This news covers the Group’s Clarava™ assay, a pre-transplant prognosis test for the risk of early acute rejection, and Tuteva™, a post-transplant diagnostic focused upon acute cellular rejection. Worldwide tens of thousands of kidney transplant procedures have regrettably been postponed by the pandemic. Indeed, even in the UK, Covid has led to delays in the diagnosis, surgery and treatment of patients, who are either at risk of death or permanently connected to dialysis machines. Importantly for investors, the potential time benefit is not included within current market expectations with further detail expected in the FY20 report, expected in April. Shares in Verici have more than doubled in value since the company was admitted to trading on AIM in November 2020 at 45.5p.
Reason to Follow 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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