IMBG has being studied in KIDNEY TRANSPLANT under a comprehensive clinical plan program, which includes a first proof of concept clinical study in 70 patients (BH-PILOT STUDY 2015), and in a multicenter international validation study, to be finished in 2Q 2019 (TRANSBIO STUDY). The BH-PILOT STUDY 2015 and the TRANSBIO STUDY will ensure that the IMMUNOBIOGRAM® is ready for implementation in a clinical laboratory and reproducible.
IMBG is also being studied in RHEUMATOID ARTHRITIS under a clinical plan program, which includes an ongoing first proof of concept clinical study in 100 patients (BH-PILOT STUDY 2018 IN RHEUMATOID ARTHRITIS). This clinical study aims to evaluate the feasibility and clinical utility of a specifically-developed IMBG for Rheumatoid Arthritis.
It is foreseen to conduct a subsequent validation multicenter and international study in Rheumatoid Arthritis.
The clinical program has been designed to cover the essential aspects of the technology for the IMBG to be used in a reliable way. It is very important to consider that IMBG is not aimed to guide directly the physician prescription. The kit offers efficacy/potency information to be considered along with epidemiological, immunological, clinical and pharmacokinetic variables, which altogether combined, will drive the decision.