Periodic Reporting for period 3 - AutoPilot-Dx (Fast tracking market adoption of a novel immune-based diagnostic for improving antibiotic stewardship: automation, piloting and health economics)
Periodo di rendicontazione: 2019-01-01 al 2019-08-31
1) Automation - ImmunoXpert™ was successfully transitioned onto Freedom EVO® 75 (Tecan), a fully automated laboratory workstation and the performance of the automated test validated at each participating medical center.
2) Piloting - We successfully completed recruitment of 1140 pediatric patients presenting with respiratory tract infection (RTI) or fever without source (FWS) at the emergency department (ED) and pediatric departments; 558 in Italy (49%) and 582 in Germany (51%). ImmunoXpert™ protein levels were measured in serum samples using the automated Tecan workstations on site for each of the 1,008 eligible patients. Reference standard labels were assigned based on unanimous expert panel labels for each of the 1,008 eligible patients. The sensitivity and specificity attained was greater than 90% based on a 2x2 performance analysis. In addition, to evaluate the potential clinical utility of the new test, a set of questionnaires were collected during the study that surveyed the physician’s clinical suspicion during the patient management course. The agreement (% agreement) and concordance (kappa) between the initial label given by the physician after examining a patient and the unanimous reference standard was calculated and compared to the same statistics for ImmunoXpert™ and the unanimous reference standard. ImmunoXpert™ was found to outperform the clinician’s initial suspicion.
2) Health economics and reimbursement - A cost-effectiveness health economic model was constructed to assess the value of introducing a new diagnostic test for differentiating between bacterial and viral infection on top of standard of care (SoC) to SoC, taking into account both diagnostic and treatment pathways. The model case study was set as pediatric patients with suspicion of lower tract infection (LRTI) presenting to the ED in Germany. The overarching finding is that introduction of ImmunoXpert™ is cost-saving.
The landscape for reimbursement of ImmunoXpert™ was mapped in five European target countries based on desk research (Germany, UK, France, Italy and Switzerland). Additional primary research was successfully accomplished in both Germany and the US to enable a more defined reimbursement strategy in these geographies.