A method for diagnosing a
disease in a subject, in particular a
hematological malignancy or a
solid tumor, comprising the steps of: isolating (21, 61) an
extracellular vesicle precipitate (3a, 3b) obtained from a sample (2) of a
biological fluid previously taken from the subject; measuring (31, 41, 51-52), from said
precipitation, parameters representative of six biomarkers: (I) the size of the
extracellular vesicles; (II) the total amount of
extracellular vesicles; (III) an amount of
extracellular vesicles expressing the first
antigen on their own surface and (IV) an amount of
extracellular vesicles expressing the first
antigen and the second
antigen; (V) an average
fluorescence intensity for each of the antigens; and (VI) the
nucleic acid content of the
extracellular vesicles; first comparing a parameter representative of the biomarker with a corresponding critical value; based on the first comparison step, assigning a partial
score to each parameter or to the six biomarkers; calculating a final
score, namely the
score of the subject, as the sum of the partial scores; a second comparison of the final score with at least one predetermined diagnostic threshold, preferably with two diagnostic thresholds, an upper diagnostic threshold and a lower diagnostic threshold; based on the second comparison step, a probabilistic diagnosis of the
lesion is estimated. Under the background of personalized
medical treatment, the combination of the six biomarkers overcomes the limitation of the prior art method caused by high clinical heterogeneity between subjects, which is specifically embodied in sensitivity to a given
lesion; in other words, a certain biomarker, not other biomarkers, selected from the six biomarkers and related parameters of the biomarkers are different.