Verici Dx Regulatory News (VRCI)

("Verici Dx" or the "Company") 

Accelerated CLIA approval strategy to enable faster commercial launch of leading products

Schultenover appointed VP of Quality and Regulatory to oversee Strategy

Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces that following a review initiated after completing its successful AIM IPO in November 2020, it is now accelerating its CLIA laboratory opening and approvals strategy for its two lead products, ClaravaTM and TutevaTM. These plans include the appointment of David Schultenover as Vice President of Quality and Regulatory with immediate effect to project manage this key objective for 2021.

David Schultenover, who is an experienced pharmaceutical and medical device quality control & quality assurance management professional with proven success as a consultant and staff member in the scientific, medical, and manufacturing industries, will be responsible for the delivery of Clinical Laboratory Improvement Amendments (CLIA) laboratory approvals.

David joins Verici Dx from Thermo Fisher Scientific, where, as Senior Director of Regulatory, Quality and Compliance, he was responsible for 154 people covering regulatory affairs, Quality Assurance and Quality Control. Prior to that he was Quality Assurance Director at MiraVista Diagnostics.

The Center for Medicare and Medicaid Services (CMS) regulates laboratory testing in the US through the CLIA regime, which requires all clinical laboratories to be certified before they can accept human samples for diagnostic testing. Laboratories can obtain multiple types of CLIA certificates, based on the kinds of diagnostic tests they conduct.

Commenting on David's appointment Sara Barrington, CEO of Verici Dx, said:

"We are delighted that Dave has joined our management group. 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. This is an important step in the commercialisation journey for our innovative transplant products and we are pleased to be expanding our management resources to help expedite CLIA approvals for our laboratories."

Verici Dx will provide further 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.

Enquiries:

About Verici Dx plc www.vericidx.com

Verici Dx is developing and commercialising tests to understand how a patient will and is responding to organ transplant, with an initial focus on kidney transplants. The body's own immune system poses a threat to a successful transplant or graft. Patients' immune systems differ in how they respond to the presence of the transplanted organ, characterising this response is called immune phenotyping. Our products and solutions are 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. These 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.

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.