A method for the diagnosis of diseases, in particular hematological malignancies or
solid tumors, in a subject comprises the steps of isolating (21,61) an
extracellular vesicle pellet (3a,3b) obtained from a sample (2) of a
biological fluid previously taken from the subject; measuring (31,41,51-52), from said pellet, parameters representative of the six biomarkers (I) size, (II) total amount of the
extracellular vesicles, (III) amount of the extra- cellular vesicles expressing on their own surface (III) a first
antigen and (IV) a first and a second
antigen, (V)
mean fluorescence intensity for each of said antigens and (VI)
nucleic acid content of the
extracellular vesicles; performing a first comparison of the biomarker-representative parameters with respective
cut-off values; assigning a partial
score to each parameter or to the six biomarkers on the basis of the above first comparison step; calculating a final
score, i.e. a subject
score, as the sum of the partial scores; performing a second comparison of the final score with at least one predetermined diagnostic threshold value, preferably with two diagnostic upper and lower values; estimating the probability diagnosis of said
pathology on the basis of the above second comparison step. The combination of the six biomarkers, in the context of
personalized medicine, overcomes the prior art method limitations due to the high clinical heterogeneity between subjects, in terms of sensitivity, with reference to a given
pathology, for one rather than the other biomarkers and their relative parameters selected from the six.