Major milestone in the commercial launch of Verici Dx’s lead products, ClaravaTM and TutevaTM
Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces that it has obtained a Clinical Laboratory Improvement Amendments (CLIA) Certification of Registration under the Centers for Medicare & Medicaid Services (CMS) for the Company’s newly established US clinical laboratory at the Innovation Park in Franklin, Tennessee, on which it took a lease in late April this year.
The Certificate of Registration authorises the Company to initiate commercial operations as a diagnostic laboratory in Tennessee. The location was selected for the high-quality premises within a healthcare hub to facilitate ease of logistics and hiring in the Palmetto region. Verici Dx expects to commercially launch its two flagship commercial products, Clarava™ and Tuteva™, in 2022.
In addition, the issuance of the CLIA Certification of Registration in Tennessee represents a milestone in the steps toward seeking a coverage determination through the MolDx Program administered by Palmetto GBA, the regional Medicare Administrative Contractor (MAC) of CMS which is responsible for services performed in laboratories located in the State of Tennessee and is also one of the largest MACs in the US.
Verici Dx’s two leading commercial clinical offerings, Clarava™ and Tuteva™, are designed to support clinician management and short and long-term graft health in kidney transplant patients. These leading-edge technologies are underpinned by extensive patented and published scientific research from Mount Sinai Medical Center for which Verici Dx holds an exclusive worldwide licence.
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. 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. We look forward to publishing validation study data on our first two products in early 2022.”
Sara Barrington, CEO
Julian Baines, Chairman
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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.