Lead products meet comprehensive requirements at CLIA-certified laboratory, representing an important milestone towards commercialisation
Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces that its two lead in vitro diagnostic assays, Clarava™ and Tuteva™, have successfully completed analytical validation under the CLIA1 requirements, meeting comprehensive criteria for robust assay performance. Publication of the study will be made later in the year providing key data to support clinical use.
Analytical validation is an essential element of defining the performance characteristics and platform capabilities of in vitro diagnostic assays, including reproducibility, accuracy, limits of detection, and risk of interferences for any clinician wanting comprehensive data about the reliability of testing. Data collected during analytical validation is essential for the subsequent clinical interpretation of assay results. The process to attain analytical validation is established by regulatory requirements under CLIA1, and its successful completion represents an important milestone towards commercialisation for both Clarava™ and Tuteva™ prior to the results of the clinical validation study expected at the end of Q1 2022.
The analytical validation data also represents a significant milestone in the pathway to reimbursement. Under the Molecular Diagnostic Services Programme (“MolDx”)2, which was developed to identify and provide coverage and reimbursement for molecular diagnostic tests under Medicare, the successful completion and submission of analytical validation studies, in addition to the clinical validation studies, are required for consideration of coverage.
Clarava™ and Tuteva™, are novel, complex RNA expression next-generation sequencing assays coupled with proprietary prediction algorithms, that aim to understand a patient’s pre and post kidney transplant immunologic response. The nature of assay processing for these tests requires specialised expertise that demonstrates precise results and for which all essential performance characteristics are verified.
Michael J. Donovan, Chief Medical Officer, Verici Dx, said: “2022 has started positively for Verici Dx and this latest successful completion of analytical validation is a significant milestone in the pathway to commercialisation, indicating that the performance characteristics and quality design capabilities of our lead tests meet the comprehensive regulatory requirements as set forth by CMS through CLIA.
“We have previously indicated that by the end of this year, the Company will have moved from being solely a Research and Development organisation to one with commercial products, and the important step of analytical validation keeps us on track to do so. A manuscript detailing the key analytical validation data is currently underway, which we look forward to sharing with the clinical community in due course.”
Sara Barrington, CEO
Julian Baines, Chairman
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