Transbiohope | OBJECTIVES
Transbio project, oriented to the development of an in vitro diagnostic kit for the treatment of chronic rejection with immunosuppressants. H2020 program of the European Union
"trasplante riñón” “diagnóstico in vitro” “in vitro diagnosis” “trasplante renal” “H2020” “European Commission project” “renal transplant” “kidney transplant” “start-up” “Tres Cantos” “biomedicina” “biomedicine” “biotechnology” “immunobiogram” “inmunobiograma” “tratamiento inmunosupresores” “Treatment with immunosuppressants”
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BioHope has already performed the basic research and we have determined the feasibility of this business venture thanks to the Phase 1 project. In this Phase 2 project, in collaboration with renowned experts in Nephrology along Europe, our ultimate goal is to prove the clinical usefulness of our technology through a clinical validation study. This will enable us to get the regulatory approval for commercialization and bring our product to the healthcare market. The specific objectives we seek during Phase 2 are as follows:


  • OT.1. To further optimize the prototype test kit, we have already developed and patented for achieving a price reduction down. This price reduction will pave the way for product commercialization, as we have been able to determine during Phase 1. A price reduction of 25-30% can be achieved by reducing the number of cellular/molecular markers involved in the assay to those most relevant. This prototype optimization will be done by a pilot clinical study involving 60 patients.
  • OT.2. To perform a multicenter clinical validation study involving about 300 patients in collaboration with Nephrology Units at 9 European hospitals. This clinical study will be aimed at validating the actual clinical and analytical relevance of the test, for its approval by the regulatory bodies.
  • OT.3. To develop a bioinformatics platform as a software tool, based on the results of the clinical validation study. The software will analyze the test results and will deliver the report with the conclusions of the test.