Another day, another important milestone reached for Verici Dx (VRCI ) wrt commercialising its 2 next generation, blood/AI based immunodiagnostics (Clarava and Tuteva) to much better predict & assess a patient's pre and post kidney transplant response & acceptance.
Today the firm said that it had successfully completed ‘analytical validation’ under the CLIA requirements. Satisfying comprehensive criteria for robust assay performance such as reproducibility, accuracy, limits of detection and risk of interference.
This formal calibration process is not only essential for the subsequent clinical interpretation of results and their reliability. But also for obtaining medical insurance cover & reimbursement codes under say the US’ Medicare system.
So what next? Well hopefully things get even better from here. With the full findings of the Clarava & Tuteva clinical validation study being released by the end of Q1’22 (say June) & first orders for the tests by the end of the year.
Chief Medical Officer Michael Donovan adding: "2022 has started positively for Verici Dx. 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.”
Onwards & upwards.