There is no “gold standard” to compare with the IMMUNOBIOGRAM. Because of that, typical sensitivity / specificity evaluation against another test will not be delivered.
A clinical program has been designed to cover the essential aspects of the technology that offers the data needed for the IMMUNOBIOGRAM to be used in a reliable way. It is very important to consider that the IMMUNOBIOGRAM will NOT directly guide physician prescription. This means that the tool does not ambition to tell the doctor what medicine should be used; we offer efficacy/potency information to be added to TDM and clinical characteristics, which altogether combined, will drive the decision. Thus, level 1 evidence is not mandatory from regulatory purposes.
In patients with a RT, the hard outcomes (in terms of graft failure or biopsy proven signs of immune rejection) are going to depend not only on the clinical decisions about the IMS regimen to be used,  but also on a pool of epidemiological (ie donors age, type-death or living donor-, recipient characteristics), clinical,  and immunological variables (ie level of HLA mismatch,  dnDSA appearance). Clinical decisions in clinical practice have always been made taking into account these important variables; the pharmacodynamic (IMMUNOBIOGRAM) and pharmacokinetic (TMD) data will complement them, helping physicians to make more precise therapeutic decisions.