Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces it has signed the lease for the premises intended to be the CLIA1-certified laboratory, situated at the Innovation Park2 in Franklin, Tennessee, US, which is within the Palmetto region for CMS Medicare governance. Palmetto GBA, LLC is one of the largest Medicare administration contractors in the US.
In January 2021, the Company appointed David Schultenover to accelerate the CLIA approval process to enable faster commercial launch of Verici Dx’s lead products, ClaravaTM and TutevaTM and setting up these premises is the first step in that accelerated pathway. The Company requires a CLIA-certified laboratory to be able to offer their diagnostic products to clinicians as a laboratory developed test (LDT) and approvals are expected by the end of the year. 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.
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. 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.”
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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.