FIELD: medicine; clinical laboratory diagnostics; oncourology.
SUBSTANCE: invention can be used for non-invasive diagnosis of bladder cancer and tumour recurrence after surgical and/or drug treatment. The invention includes a method of quantitative analysis of tumour DNA carrying mutations in the GPR126 gene enhancer in biological fluids, as well as a set of reagents for digital polymerase chain reaction, which allows it to be carried out. DNA is isolated from biological fluid, quantitative analysis of tumour DNA (Cmut), wild type DNA (Cwt), and calculation of the tumour DNA fraction (F) using the formula F = ((Cmut/(Cwt + C mut)) - 0.0185)× 100%. When an F value of more than 0% is obtained, a conclusion is drawn about the presence of bladder cancer. If the F value is equal to or less than 0%, it is concluded that there is no bladder cancer.
EFFECT: method and set of reagents for its implementation allow non-invasive diagnosis of bladder cancer in the early stages of the disease with a low probability of false-positive results, since mutations in the GPR126 gene enhancer are not found in healthy cells of the body.
5 cl, 4 dwg, 1 tbl
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