METHOD FOR EARLY DIAGNOSIS OF PROSTATE TUMORS Russian patent published in 2021 - IPC C12Q1/68 C12N15/00 

FIELD: biotechnology and diagnostic medicine.

SUBSTANCE: invention relates to the field of biotechnology and diagnostic medicine. Blood and urine are collected from the patient, free cirDNA is isolated from plasma, total cirDNA from blood supernatant, ecDNA from urine supernatant, and cirDNA and ecDNA are modified with sodium bisulfite. Next, at least three (for the diagnosis of prostate cancer) or two (for the diagnosis of BPH) aberrant-methylated marker cytosines are detected in individual DNA molecules in the promoter regions of the GSTP1 (NG_012075.1, 4998-5139) and RNF219 (NC_000013.11, 125-285) by any known method, for example by mass parallel sequencing or by real-time PCR. When aberrant-methylated cytosines are detected by direct sequencing, PCR products of two studied genes are generated, libraries are prepared, and then massive parallel sequencing. When detecting aberrant methylated cytosines by PCR, several (up to five) real-time PCR reactions are performed using various combinations of primers and TaqMan probes specific to the sequences of the promoter regions of the studied genes GSTP1 and RNF219.

EFFECT: allows reducing the duration of the method, as well as to increase the sensitivity, specificity and accuracy of early diagnosis of prostate tumors (prostate cancer or BPH).

8 cl, 11 tbl, 6 ex