Identifying biomarker for detecting kidney disease with diabetes, comprises isolating exosome from urine of e.g. biopsy-proven kidney disease sample, extracting RNA, analyzing microRNA expression of RNA sample followed by assessing detection accuracy and optimal cut-off fold expression of biomarker
	MISHRA D D; TIWARI S
	2023-09-22
专利权人	GANDHI POSTGRADUATE INST MEDICAL SCI (GAND-Non-standard) ; INDIAN COUNCIL MEDICAL RES (INCO-Non-standard)
申请日期	2023-09-22
专利号	IN202311063851-A
成果简介	NOVELTY - Identifying biomarker comprises: (i) isolating exosomes from urine of biopsy-proven diabetic nephropathy samples, biopsy-proven non-diabetic kidney disease samples, biopsy-proven kidney disease, and no-disease control samples; (ii) optionally characterizing the exosomes; (iii) extracting RNA samples from the isolated exosomes; (iv) analyzing and comparing microRNA expression of RNA samples isolated from biopsy-proven diabetic nephropathy samples with RNA samples isolated from no-disease control samples, analyzing and comparing microRNA expression of RNA samples isolated from biopsy-proven non-diabetic kidney disease samples with RNA sample isolated from no-disease control samples, and analyzing and comparing microRNA expression of RNA samples isolated from biopsy-proven kidney disease with RNA samples isolated from no-disease control samples; (v) confirming and validating selected biomarkers; and (vi) assessing detection accuracy and optimal cut-off fold expression of biomarkers. USE - Method for identifying biomarker for detecting kidney disease with diabetes and differentially detecting non-diabetic kidney disease from diabetic nephropathy in a subject with diabetes (claimed). ADVANTAGE - The method ensures optimal sensitivity and specificity through a non-invasive approach, and eliminates the need of renal biopsy. DETAILED DESCRIPTION - Identifying biomarker comprises: (i) isolating exosomes from urine of biopsy-proven diabetic nephropathy samples, biopsy-proven non-diabetic kidney disease samples, biopsy-proven kidney disease, and no-disease control samples; (ii) optionally characterizing the exosomes; (iii) extracting RNA samples from the isolated exosomes; (iv) analyzing and comparing microRNA expression of the RNA samples isolated from the biopsy-proven diabetic nephropathy samples with RNA samples isolated from the no-disease control samples, analyzing and comparing microRNA expression of the RNA samples isolated from the biopsy-proven non-diabetic kidney disease samples with the RNA sample isolated from the no-disease control samples, and analyzing and comparing microRNA expression of the RNA samples isolated from the biopsy-proven kidney disease with RNA samples isolated from the no-disease control samples, to identify biomarkers; (v) confirming and validating the selected biomarkers; and (vi) assessing detection accuracy and optimal cut-off fold expression of biomarkers, where the biomarkers are microRNA such as miR-3613-5p, miR-4462, miR-1972, and miR-320b. INDEPENDENT CLAIMS are included for: 1. a method for detecting kidney disease with diabetes and differentially detecting non-diabetic kidney disease from diabetic nephropathy in a subject with diabetes, which comprises: (a) isolating exosomes from urine sample of the subject; (b) extracting RNA sample from the isolated exosomes; (c) determining the expression level of at least two microRNA in RNA sample; (d) normalizing microRNA expression with spike-in controls; and (e) interpreting the results based on the identified optimal cut-off fold expression for microRNAs; 2. panel, which comprises at least one microRNA for detecting kidney disease in a subject with diabetes; and 3. kit for detecting kidney disease in a subject with diabetes, which comprises an RNA sample extracted from exosomes of urine sample of the subject, a panel of at least one microRNA, reagents including spike-in controls, and an instruction manual for determining the fold expression of microRNA in the RNA sample and interpreting the results.
IPC 分类号	A61P-013/12 ; A61P-021/00 ; A61P-027/02 ; A61P-003/10 ; G01N-033/68
国家	印度
专业领域	医药卫生
语种	英语
成果类型	专利
文献类型	科技成果
条目标识符	http://119.78.100.226:8889/handle/3KE4DYBR/20283
专题	中国科学院新疆生态与地理研究所
作者单位	1.GANDHI POSTGRADUATE INST MEDICAL SCI (GAND-Non-standard) 2.INDIAN COUNCIL MEDICAL RES (INCO-Non-standard)
推荐引用方式 GB/T 7714	MISHRA D D,TIWARI S. Identifying biomarker for detecting kidney disease with diabetes, comprises isolating exosome from urine of e.g. biopsy-proven kidney disease sample, extracting RNA, analyzing microRNA expression of RNA sample followed by assessing detection accuracy and optimal cut-off fold expression of biomarker. IN202311063851-A[P]. 2023.

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