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(Sharecast News) - Clinical diagnostics developer Verici Dx announced on Tuesday that its two lead in-vitro diagnostic assays, 'Clarava' and 'Tuteva', had completed analytical validation under the CLIA requirements, meeting criteria for robust assay performance.
The AIM-traded firm said the study would be published later in the year, providing key data to support clinical use.
It said analytical validation was 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 comprehensive data about the reliability of testing.
Data collected during validation was essential for the subsequent clinical interpretation of assay results.
The firm said the process to attain analytical validation was established by regulatory requirements under CLIA, and its successful completion represented an "important milestone" towards commercialisation for both Clarava and Tuteva, before the results of the clinical validation study, expected at the end of the first quarter.
Verici said the validation data also represented a milestone in the pathway to reimbursement.
Under the Molecular Diagnostic Services Programme, which was developed to identify and provide coverage and reimbursement for molecular diagnostic tests under Medicare in the United States, the completion and submission of analytical validation studies, as well as clinical validation studies, were required for consideration of coverage.
The company described Clarava and Tuteva as novel, complex RNA expression next-generation sequencing assays coupled with proprietary prediction algorithms, that were designed to understand a patient's pre- and post-kidney transplant immunologic response.
It said the nature of assay processing for the tests required specialised expertise to demonstrate precise results, and for which all essential performance characteristics were verified.
"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," said the firm's chief medical officer, Michael Donovan.
"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."
At 0852 GMT, shares in Verici Dx were down 0.84% at 44.12p.
