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US 9,803,242 B2Granted
miRNA-based universal screening test (UST)
AssigneeDiamir, LLC
InventorsSamuil R. Umansky, Kira S. Sheinerman, Vladimir Tsivinsky
Life of this patent
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Abstract
Described are methods for early noninvasive or minimally invasive detection of pathological changes in organ systems/organs/tissues/cells by quantifying organ system-/organ-/tissue-/cells type-enriched miRNA in bodily fluids.
Claims11
A method for selecting subjects for administering one or more disease-specific diagnostic tests to identify a specific pathology in the gastrointestinal (GI) system and/or the respiratory system and/or the nervous system, which method comprises:
- a. for each of the gastrointestinal (GI) system, the respiratory system and the nervous system, measuring the level of one or more biomarker miRNAs in a bodily fluid sample collected from a subject of interest, wherein the bodily fluid is selected from the group consisting of blood plasma, serum, urine, and saliva;
- b. for each of the biomarker miRNAs measured in step (a), measuring the level of a normalizer miRNA in the same bodily fluid sample collected from the subject of interest;
- c. calculating the ratio of the level of the biomarker miRNA measured in step (a) to the level of the normalizer miRNA measured in step (b) for each of said organ systems;
- d. comparing the ratio calculated in step (c) with a corresponding control ratio for each of said organ systems, wherein the corresponding control ratio was determined in a corresponding bodily fluid collected from the subject of interest in the past, or from a different subject or a population of subjects without pathology of the respective organ systems, and
- e. determining for at least one biomarker miRNA measured in step (a) that the ratio calculated in step (c) is greater in the bodily fluid sample collected from the subject of interest than the corresponding control ratio, and administering one or more disease-specific diagnostic tests to the subject of interest,
- wherein the biomarker miRNA for the gastrointestinal (GI) system measured in step (a) is selected from the group consisting of miR-31, miR-130b, miR-136, miR-141, miR-143, miR-145, miR-148a, miR-192, miR-203, miR-215, miR-375, miR-376c, miR-429, miR-455-5p, miR-650, miR-106a, miR-106b, miR-205, miR-210, miR-221, miR-7, miR-26a, miR-26b, miR-26c, miR-124b, miR-182, miR-188, miR-197, miR-194, miR-200a, miR-200b, miR-200c, miR-321, and the normalizer miRNA measured in step (b) is selected from the group consisting of miR-30e-3p, miR-145, and miR-148a;
- the biomarker miRNA for the respiratory system measured in step (a) is selected from the group consisting of miR-486-5p, miR-34b, miR-192, miR-135b, miR-146, miR-146b-5p, miR-155, miR-199b-5p, miR-200c, miR-205, miR-223, miR-302b, and miR-375, and the normalizer miRNA measured in step (b) is selected from the group consisting of miR-142-5p, miR-146b-5p, miR-155, miR-223, and miR-409-3p;
- and
- the biomarker miRNA for the nervous system measured in step (a) is selected from the group consisting of miR-128, miR-132, miR-874, miR-134, miR-323-3p, miR-382, miR-Let-7a, miR-7, miR-9, miR-124a, miR-125a, miR-125b, miR-135a, miR-137, miR-138, miR-181a, miR-181c, miR-182, miR-184, miR-211, miR-212, miR-213, miR-218, miR-219, miR-222, miR-338-5p, miR-369, miR-381, miR-409-3p, miR-425, miR-433-5p, miR-485-5p, miR-491-5p, miR-539, miR-541, miR-543, miR-656, miR-935, miR-939, and miR-9*, and the normalizer miRNAs measured in step (b) is selected from the group consisting of miR-9, miR-181a, miR-491-5p, miR-141, miR-127, miR-370, and miR-433-5p.
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