US2014221325A1PendingUtilityA1

Glomerulonephritis biomarkers

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Assignee: MESO SCALE TECHNOLOGIES LLCPriority: Feb 1, 2013Filed: Jan 30, 2014Published: Aug 7, 2014
Est. expiryFeb 1, 2033(~6.5 yrs left)· nominal 20-yr term from priority
Inventors:Eli N. GlezerJohn KentenGalina Nikolenko
G01N 33/6893G01N 2800/347G01N 2800/52A61M 1/1603A61M 1/3496A61M 1/3624A61M 1/1676
56
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Claims

Abstract

The present invention relates to methods of diagnosing glomerulonephritis (GN) in a patient, as well as methods of monitoring the progression of GN and/or methods of monitoring a treatment protocol of a therapeutic agent or a therapeutic regimen. The invention also relates to assay methods used in connection with the diagnostic methods described herein.

Claims

exact text as granted — not AI-modified
1 . A method for evaluating the efficacy of a treatment regimen in a patient diagnosed with glomerulonephritis (GN), said method comprising
 (a) obtaining a test sample from a patient undergoing said treatment regimen for GN;   (b) measuring a level of a biomarker in said test sample, wherein said biomarker comprises Clusterin, KIM-1, aGST, IL-6, CHGA, E-Cadherin, Timp-1, TNF-RI, TNF-RII, UMOD, OPGN, Calbindin, Osteoactin, Albumin, B2M, Cystatin C, NGAL, MCP-1, IL-15, ICAM-1, KDR, LBP, PRDX4, Prolactin, PSAT1, S100A4, TIMP-1, VCAM-1, EGF, SERPINB3, and combinations thereof;   (c) comparing said level to a normal control level of said biomarker; and   (d) evaluating from said comparing step (c) whether said patient is responsive to said treatment regimen.   
     
     
         2 . A method for evaluating the efficacy of a treatment regimen in a patient diagnosed with glomerulonephritis (GN), said method comprising
 (a) ordering a test comprising a measurement of a level of a biomarker in a test sample obtained from a patient undergoing said treatment regimen for GN, wherein said biomarker comprises Clusterin, KIM-1, aGST, IL-6, CHGA, E-Cadherin, Timp-1, TNF-RI, TNF-RII, UMOD, OPGN, Calbindin, Osteoactin, Albumin, B2M, Cystatin C, NGAL, MCP-1, IL-15, ICAM-1, KDR, LBP, PRDX4, Prolactin, PSAT1, S100A4, TIMP-1, VCAM-1, EGF, SERPINB3, and combinations thereof;   (b) comparing said level to a normal control level of said biomarker; and   (c) evaluating from said comparing step (b) whether said patient is responsive to said treatment regimen.   
     
     
         3 . A method of administering a treatment regimen to a patient in need thereof for treating glomerulonephritis (GN), comprising:
 (a) obtaining a test sample from a patient undergoing said treatment regimen for GN;   (b) measuring a level of a biomarker in said test sample, wherein said biomarker comprises Clusterin, KIM-1, aGST, IL-6, CHGA, E-Cadherin, Timp-1, TNF-RI, TNF-RII, UMOD, OPGN, Calbindin, Osteoactin, Albumin, B2M, Cystatin C, NGAL, MCP-1, IL-15, ICAM-1, KDR, LBP, PRDX4, Prolactin, PSAT1, S100A4, TIMP-1, VCAM-1, EGF, SERPINB3, and combinations thereof;   (c) comparing said level to a normal control level of said biomarker;   (d) evaluating from said comparing step (c) whether said patient is responsive to said treatment regimen; and   (e) adjusting said treatment regimen based on said evaluating step (d).   
     
     
         4 . A method of administering a treatment regimen to a patient in need thereof for treating glomerulonephritis (GN), comprising:
 (a) obtaining a test sample from a patient prior to the commencement of said treatment regimen for GN;   (b) measuring a level of a biomarker in said test sample, wherein said biomarker comprises Clusterin, KIM-1, aGST, IL-6, CHGA, E-Cadherin, Timp-1, TNF-RI, TNF-RII, UMOD, OPGN, Calbindin, Osteoactin, Albumin, B2M, Cystatin C, NGAL, MCP-1, IL-15, ICAM-1, KDR, LBP, PRDX4, Prolactin, PSAT1, S100A4, TIMP-1, VCAM-1, EGF, SERPINB3, and combinations thereof;   (c) comparing said level to a normal control level of said biomarker;   (d) evaluating from said comparing step (c) whether said patient will be responsive to said treatment regimen; and   (e) administering said treatment regimen based on said evaluating step (d).   
     
     
         5 . A method of administering a treatment regimen to a patient in need thereof for treating glomerulonephritis (GN), comprising:
 (a) evaluating a level of a biomarker in a test sample obtained from a patient undergoing said treatment regimen for GN relative to a normal control level of said biomarker, wherein said biomarker comprises Clusterin, KIM-1, aGST, IL-6, CHGA, E-Cadherin, Timp-1, TNF-RI, TNF-RII, UMOD, OPGN, Calbindin, Osteoactin, Albumin, B2M, Cystatin C, NGAL, MCP-1, IL-15, ICAM-1, KDR, LBP, PRDX4, Prolactin, PSAT1, S100A4, TIMP-1, VCAM-1, EGF, SERPINB3, and combinations thereof; and   (b) adjusting said treatment regimen based on said evaluating step (a).   
     
     
         6 . A method of administering a treatment regimen to a patient in need thereof for treating glomerulonephritis (GN), comprising:
 (a) evaluating a level of a biomarker in a test sample obtained from a patient prior to the commencement of said treatment regimen for GN relative to a normal control level of said biomarker, wherein said biomarker comprises Clusterin, KIM-1, aGST, IL-6, CHGA, E-Cadherin, Timp-1, TNF-RI, TNF-RII, UMOD, OPGN, Calbindin, Osteoactin, Albumin, B2M, Cystatin C, NGAL, MCP-1, IL-15, ICAM-1, KDR, LBP, PRDX4, Prolactin, PSAT1, S100A4, TIMP-1, VCAM-1, EGF, SERPINB3, and combinations thereof; and   (b) administering said treatment regimen based on said evaluating step (a).   
     
     
         7 . A method according to  claim 1  wherein said measuring step comprises conducting a multiplexed assay measurement of a plurality of said biomarkers in said test sample, wherein said multiplexed assay measurement is conducted using one reaction volume comprising said test sample. 
     
     
         8 . The method of  claim 1  wherein said method comprises measuring levels of two or more biomarkers. 
     
     
         9 . The method of  claim 8  wherein said measuring step comprises measuring levels of a first biomarker and an additional biomarker comprising Clusterin, KIM-1, aGST, IL-6, CHGA, E-Cadherin, Timp-1, TNF-RI, TNF-RII, UMOD, OPGN, Calbindin, Osteoactin, Albumin, B2M, Cystatin C, NGAL, MCP-1, IL-15, ICAM-1, KDR, LBP, PRDX4, Prolactin, PSAT1, S100A4, TIMP-1, VCAM-1, EGF, SERPINB3, and combinations thereof. 
     
     
         10 . A method of  claim 8  wherein said first biomarker and said additional biomarker are selected from: Clusterin, KIM-1, aGST, IL-6, CHGA, E-Cadherin, Timp-1, TNF-RI, TNF-RII, and UMOD. 
     
     
         11 . A method of  claim 1  further comprising one or more additional measuring steps including:
 (x) measuring a baseline level(s) of said biomarker before said treatment regimen is initiated, and said evaluating step further comprises comparing said level and said baseline level; and 
 (y) measuring an interim level of said biomarker during said treatment regimen and said evaluating step further comprises comparing said level, said interim level and said baseline level. 
 
     
     
         12 . The method of  claim 1 , wherein said evaluating step comprises comparing said level of said biomarker to a detection cut-off level, wherein said level above said detection cut-off level is indicative of GN. 
     
     
         13 . The method of  claim 1 , wherein said evaluating step comprises comparing said level of said biomarker to a detection cut-off level, wherein said level below said detection cut-off level is indicative of GN. 
     
     
         14 . The method of  claim 1  further comprising determining from said level of said biomarker the disease progression of GN. 
     
     
         15 . A multiplexed assay kit used to evaluate the efficacy of a treatment regimen in a patient diagnosed with glomerulonephritis (GN), said kit is configured to measure a level of a plurality of biomarkers in a patient sample, said plurality of biomarkers comprises Clusterin, KIM-1, aGST, IL-6, CHGA, E-Cadherin, Timp-1, TNF-RI, TNF-RII, UMOD, and combinations thereof. 
     
     
         16 . The kit of  claim 15  wherein said kit is further configured to compare said level to a level of a normal control. 
     
     
         17 . The kit of  claim 15  wherein said kit comprises a multi-well assay plate and wherein a well of said assay plate comprises a plurality of assay domains, at least two of said assay domains comprising reagents for measuring different biomarkers. 
     
     
         18 . The kit of  claim 15  wherein said kit comprises an assay cartridge for conducting a plurality of assays, said cartridge comprising a flow cell having an inlet, an outlet or a detection chamber, said inlet, detecting chamber, or outlet defining a flow path through said flow cell, said detection chamber configured to measure said level of said plurality of biomarkers in said sample. 
     
     
         19 . The kit of  claim 15  wherein said kit further comprises one or more additional assay reagents used in said assay, said one or more additional assay reagents provided in one or more vials, containers, or compartments of said kit. 
     
     
         20 . A kit for the analysis of a kidney disease panel comprising
 (a) a multi-well assay plate comprising a plurality of wells, each well comprising at least four discrete binding domains to which capture antibodies to the following human analytes are bound: Clusterin, KIM-1, aGST, IL-6, CHGA, E-Cadherin, Timp-1, TNF-RI, TNF-RII, UMOD, and combinations thereof;   (b) in one or more vials, containers, or compartments, a set of labeled detection antibodies specific for said human analytes; and   (c) in one or more vials, containers, or compartments, a set of calibrator proteins.   
     
     
         21 . The kit of  claim 20  wherein said kit further comprises one or more diluents. 
     
     
         22 . The kit of  claim 20  wherein said detection antibodies are labeled with an electrochemiluminescent (ECL) label. 
     
     
         23 . The kit of  claim 22  wherein said kit further comprises an ECL read buffer. 
     
     
         24 . The kit of  claim 20  wherein said discrete binding domains are positioned on an electrode within said well. 
     
     
         25 . The kit of  claim 20  wherein said set of calibrator proteins comprise a lyophilized blend of proteins. 
     
     
         26 . The kit of  claim 20  wherein said set of calibrator proteins comprise a liquid formulation of calibrator proteins. 
     
     
         27 . The method of  claim 1 , wherein said sample comprises serum and said biomarker comprises Clusterin, KIM-1, aGST, IL-6, CHGA, E-Cadherin, Timp-1, TNF-RI, TNF-RII, UMOD, and combinations thereof. 
     
     
         28 . The method of  claim 1 , wherein said sample comprises urine and said biomarker comprises OPGN, Calbindin, Clusterin, Osteoactin, Albumin, B2M, Cystatin C, NGAL, MCP-1, IL-6, IL-15, CHGA, E-Cadherin, ICAM-1, KDR, LBP, PRDX4, Prolactin, PSAT1, S100A4, TIMP-1, TNF-RI, TNF-RII, VCAM-1, EGF, UMOD, SERPINB3, and combinations thereof. 
     
     
         29 . The method of  claim 1  wherein said sample comprises serum and/or urine and said biomarker comprises OPGN, Calbindin, Clusterin, Osteoactivin, TFF3, B2M, Cystatin C, EGF, NGAL, MCP-1, IL-6, IL-8, IL-15, IL-7, SERPINB3, CHGA, ICAM-1, KDR, LBP, PRDX4, Prolactin, PSAT1, S100A4, TIMP-1, TNF-R1, TNF-RII, VCAM-1 and combinations thereof. 
     
     
         30 . The method of  claim 29  wherein said method further comprises determining the fractional excretion of said biomarker.

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