WE HAVE CONSISTENT RESULTS IN SEVERAL INDEPENDENT CLINICAL STUDIES
“Longitudinal observational study to determine the correlation between the patient’s pharmacodynamic response to immunosuppressive therapy measured in vitro with IMMUNOBIOGRAM and the presence of signs of immune rejection in graft biopsies in patients with Renal Transplantation.”
A multicenter observational study of two cohorts (a prospective cohort and a cross-sectional cohort) designed to determine whether there is an association between the in vitro pharmacodynamic response to individual immunosuppressants taken by the patient measured with IMBG and the existence of anatomo-pathological signs of rejection in the biopsies of the renal graft according to the BANFF classification criteria in the study population.
“Characterization of the pharmacodynamic response profile to individual immunosuppressants, measured in vitro with a novel bioassay (IMMUNOBIOGRAM) in kidney transplant patients in the maintenance phase.”
A multicenter observational study designed to describe the distribution of values of the parameters of the IMBG dose-response curves for all the immunosuppressants tested in two populations of patients in the maintenance phase of renal Transplantation, (patients with rejection and patients with opportunistic infections).
“Characterization of the dose-response curves and clinical outcomes of Immunobiogram®, a new method of in vitro diagnostics to evaluate the profile of resistance to an immunosuppressant in a representative cohort of patients with renal transplant.”
The results of this study showed the distribution of Immunobiogram values in a representative sample of patients with renal transplant, and allowed to build a Z-Score to position each patient according to their response to each immunosupressant in relation with the reference population.
“Evaluation of the clinical consistency and analytical robustness of Immunobiogram® as an In Vitro Diagnostics BIOtechnological Tool to help decision-making in adjustment of immunosuppressant therapy for Renal TRANSplant.”
This study was an observational, multi-center study to determine if a new blood test (Immunobiogram®) done after renal transplant could help predict the patient’s pharmacodynamic response to individual immunosuppressants and if the sensitivity to the immunosuppressants is associated with clinical outcomes (graft rejection)
In this clinical study, the technology was validated, the robustness of the bioassay was evaluated, and a correlation between the current clinical prognoses of each patient and resistance patterns was demonstrated.
“Pilot study of the evaluation of a diagnostic blood test based on the immune response profile analysis, for the identification of biomarkers associated with the tolerance or the chronic rejection of renal transplant.”
It was Biohope’s first study; a Proof-of-Concept study that demonstrated that the Immunobiogram allows to represent the patient’s response to each immunosupressant with a dose-response curve.