Verici Dx’s (VRC ) two lead in vitro diagnostic assays, Clarava™ and Tuteva™, have now successfully completed analytical validation at a CLIA-certified laboratory which the company said represents an important milestone towards the planned commercialisation of the assays.
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 interference for any clinician wanting data about the reliability of testing.
The data collected during analytical validation is seen as essential for the subsequent clinical interpretation of assay results, and the process to attain analytical validation is established by regulatory requirements set by the Clinical Laboratory Improvement Amendments (“CLIA”).
Verici, a developer of advanced clinical diagnostics for organ transplants, said the 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 1Q22.
The 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.
Verici’s Clarava™ assay is a pre-transplant prognosis test for the risk of early acute rejection, while Tuteva™ is a post-transplant diagnostic focused upon acute cellular rejection. Both products aim to understand how a patient will and is responding to kidney transplantation.
The assay processing for these tests requires specialised expertise that demonstrates precise results and for which all essential performance characteristics are verified, Verici explained.
Commenting on this morning’s news, Michael J. Donovan, Chief Medical Officer, Verici Dx, told investors: “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.”
He said: “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.”
Donovan added that a manuscript detailing the key analytical validation data is currently underway.
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