IP Library Granted Patent US 10,545,157
Granted Patent B2
US 10,545,157 · App. 15/026,577 · Granted Jan 28, 2020

Kidney disease biomarker

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Quick Facts
Patent No.
US 10,545,157
App. No.
15/026,577
Granted
Jan 28, 2020
Kind
B2
Abstract

The disclosure provides methods and solid states devices for detecting and staging chronic kidney disease in a patient, where the levels of biomarkers in a sample obtained from a patient are elevated or reduced compared to the levels in a sample obtained from healthy subject. In addition, the disclosure provides the use of methods and solid state devices for measurement of specific biological markers for determining the efficacy of a treatment for chronic kidney disease and for determining a drug treatment protocol for a subject suffering from chronic kidney disease.

Claims (16)

1. A method for detecting kidney disease, comprising

obtaining a serum, blood or plasma sample from a subject;

contacting the serum, blood or plasma sample with a solid support having immobilized thereon a plurality of antibodies that specifically bind to the biomarkers complement C3a (des) Arg (C3a desArg), macrophage inflammatory protein 1 alpha (MIP1α) and optionally any of the biomarkers selected from group (a) or group (b) consisting of:

(a) Interleukin-8 (IL-8), adiponectin (ADPN), dipeptidyl peptidase 4 (CD26), c-reactive protein (CRP), cystatin c (CYSC), D-dimer, endothelial growth factor (EGF), e-selectin (ESEL), granulocyte-macrophage colony stimulating factor (GMCSF), intercellular adhesion molecule 1 (ICAM1), interferon gamma (IFNγ), interleukin 10 (IL10), interleukin 15 (IL15), interleukin 1β(IL1β), interleukin 5 (IL5), interleukin 6 (IL6), liver fatty acid binding protein (LFABP), monocyte chemotactic protein 1 (MCP1), matrix metalloproteinase 9 (MMP9), neutrophil gelatinase-associated lipocalin (NGAL), p selectin (PSEL), soluble interleukin 2 alpha (sIL2α), soluble tumour necrosis factor receptor 2 (STNFR2), soluble tumour necrosis factor 1 (STNFR1), tumour necrosis factor alpha (TNFα), vascular endothelial growth factor (VEGF), vascular cell adhesion molecule 1 (VCAM1), and any combination thereof;

(b) creatinine, interleukin-4 (IL4), L-selectin (LSEL), neuron specific enolase (NSE), interleukin 1α (IL1α), and

measuring the binding of said biomarkers to the antibodies on the solid support, wherein if C3a desArg and MIP1α are increased in the sample with respect to a normal control value, and optionally whether one or more biomarker from group (a) are increased and one or more biomarkers from group (b) are decreased with respect to a normal control value is indicative of kidney disease.

2. A method according to claim 1 , wherein the kidney disease is stage 1, stage 2 or stage 3 chronic kidney disease.

3. A method according to claim 1 , wherein the sample is plasma or serum.

4. A method according to claim 1 , wherein the plurality of antibodies are detectably-labelled.

5. A method according to claim 4 , wherein the detectable label is horse-radish peroxidase.

6. A method according to claim 1 , wherein the solid support is a biochip.

7. A method according to claim 6 , wherein the amount of a biomarker in the sample is measured using a sandwich ELISA assay.

8. A method according to claim 1 , wherein the levels of C3a desArg, CYSC and MIP1α are measured.

9. A method according to claim 1 , wherein the levels of C3a desArg, GMCSF, CYSC and MIP1α are measured.

10. A method according to claim 1 , wherein the levels of C3a desArg, TNFA, CYSC and MIP1α are measured.

11. A method according to claim 1 , wherein the levels of C3a desArg, CRP, CYSC, EGF, FABP1, IL8, sTNFR1, sTNFR2, D-dimer, NGAL and MIP1α are measured.

Assignments (3)
CORRECTIVE ASSIGNMENT TO CORRECT THE NATURE OF CONVENYANCE PREVIOUSLY RECORDED AT REEL: 055950 FRAME: 0471. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Recorded Apr 20, 2021
From: RANDOX LABORATORIES LIMITED
To: NORTHERN BANK LIMITED
Reel/Frame 056210/0055 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 15, 2021
From: RANDOX LABORATORIES LIMITED
To: NORTHERN BANK LIMITED
Reel/Frame 055950/0471 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 29, 2019
From: MCCONNELL, IVAN; RICHARDSON, CIARAN; LAMONT, JOHN; FITZGERALD, STEPHEN PETER
To: RANDOX LABORATORIES LTD.
Reel/Frame 051382/0859 →