BIOHOPE is developing a blood-based in vitro diagnosis test to personalize immunosuppressant therapy for renal transplanted patients under treatment with immunosuppressant drugs. This diagnostic kit been named Immunobiogram® (IMBG) – Transplant.
Inmunobiogram® is being studied in Renal Transplantation under a comprehensive clinical plan program, which includes a first proof of concept clinical study in 70 patients (BH-Pilot) and an international validation study in 200 patients (TRANSBIO clinical study)
“BH-Pilot” was a clinical study performed in 2017 in “La Paz” and “Puerta de Hierro” University Hospitals (Madrid). An interim analysis showing a positive proof of concept was presented at an investigator meeting with our Scientific Advisory Board held in the context of the European Society of Organ Transplantation (Barcelona, 24-27 September 2017). Final results coming from 70 patients indicate that Inmunobiogram® has shown the ability to measure the sensitivity of patients to Immunosuppressant medication (IMS), and on top of that, it can detect patients with bad prognosis due to IMS low sensitivity. The classification of immunoassay profiles, initially done by an expert, can be reproduced quite accurately by a neural network and thus completely automatized.
TRANSBIO clinical study is an international (European and USA), multicenter, 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. Transbio study is beginning in April 2018 and it is expected to give conclusive results in 2019.