MINIMALLY INVASIVE METHOD FOR DIAGNOSTICS OF LUNG CANCER ON BASIS OF CHANGING COPY NUMBER OF MTDNA HV2 LOCUS Russian patent published in 2019 - IPC C12Q1/68 

FIELD: biotechnology.

SUBSTANCE: invention relates to biotechnology. Determination of the copy number of the genetic locus HV2 relative to the reference GAPDH gene is carried out by PCR-RV in the presence of the EVA-Green dye. Use highly specific primers: to HV2 F – GGGAGCTCTCCATGCATTTGGTA, R – AAATAATAGGATGAGGCAGGAATC; to GAPDH F – GCTGAACGGGAAGCTCACT, R – GCAGGTTTTTCTAGACGGCAG on the matrix of the isolated vDNA. Calculate the relative copy number of the gene (rC) according to the formula rC = -2^-ΔCt, where Ct is the median of the fluorescence signals, ΔC_t = C_t(HV2) – C_t(GAPDH), and compare the obtained rC values with the predictive copy number interval. With values rC_HV2 > 16,169 ± 3,423 diagnose the absence of malignant tumors of the lung, with values rC_HV2 < 1,756 ± 496 a patient is diagnosed with lung cancer, and with values rC_HV2 between the specified intervals consider the result to be undefined. Method has high sensitivity and specificity, its use is carried out with blood plasma; registration of the results produced once at the end of the study, which takes less than 5 hours.

EFFECT: method allows to make the procedure of primary diagnosis of lung cancer more simple, accurate and comfortable for the patient, as well as to increase the level of early detection of the disease.

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