US2013288912A1PendingUtilityA1

Biomarker signatures and uses thereof

47
Assignee: BORREBAECK CARL ARNE KRISTERPriority: Sep 7, 2010Filed: Sep 7, 2011Published: Oct 31, 2013
Est. expirySep 7, 2030(~4.1 yrs left)· nominal 20-yr term from priority
Inventors:Carl Arne Krister BorrebaeckLars Bertil Christer Wingren
G01N 33/564G01N 2800/104G01N 2800/60G01N 33/6893B82Y 30/00
47
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Claims

Abstract

The invention provides a method for determining a Systemic Lupus Erythematosus-associated disease state in a subject comprising the steps of (a) providing a sample to be tested; and (b) measuring the presence and/or amount in the test sample of one or more biomarker(s) selected from the group defined in Table 1, wherein the presence and/or amount in the test sample of the one or more biomarker(s) selected from the group defined in Table 1 is indicative of a Systemic Lupus. The invention also provides an array and a kit suitable for use in the methods of the invention.

Claims

exact text as granted — not AI-modified
1 . A method for determining a Systemic Lupus Erythematosus-associated disease state in a subject comprising the steps of:
 a) providing a sample to be tested; and   b) measuring the presence and/or amount in the test sample of one or more biomarker(s) selected from the group defined in Table 1;   
       wherein the presence and/or amount in the test sample of the one or more biomarker(s) selected from the group defined in Table 1 is indicative of a Systemic Lupus Erythematosus-associated disease state. 
     
     
         2 . The method according to  claim 1  further comprising the steps of:
 c) providing a control sample from an individual with a different Systemic Lupus Erythematosus-associated disease state to the test subject; and 
 d) measuring the presence and/or amount in the control sample of the one or more biomarkers measured in step (b); 
 wherein the Systemic Lupus Erythematosus-associated disease state is identified in the event that the presence and/or amount in the test sample of the one or more proteins measured in step (b) is different from the presence and/or amount in the control sample. 
 
     
     
         3 . The method according to  claim 1  or  2  wherein step (b) comprises or consists of measuring the presence and/or amount in the test sample of one or more of the biomarkers defined in Table 1A, for example, two of the biomarkers defined in Table 1A. 
     
     
         4 . The method according to  claim 1  or  2  wherein step (b) comprises or consists of measuring the presence and/or amount in the test sample of one or more of the biomarkers defined in Table 1B, for example, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 21, 32, 33, 34, 35, 36, 37 or 38 of the biomarkers defined in Table 1B. 
     
     
         5 . The method according to  claim 1  or  2  wherein step (b) comprises or consists of measuring the presence and/or amount in the test sample of one or more of the biomarkers defined in Table 1C, for example, 2 or 3 of the biomarkers defined in Table 1C. 
     
     
         6 . The method according to  claim 1  or  2  wherein step (b) comprises or consists of measuring the presence and/or amount in the test sample of one or more of the biomarkers defined in Table 1D, for example, 2, 3, 4, 5, 6 or 7 of the biomarkers defined in Table 1D. 
     
     
         7 . The method according to  claim 1  or  2  wherein step (b) comprises or consists of measuring the presence and/or amount in the test sample of the biomarker defined in Table 1E. 
     
     
         8 . The method according to  claim 1  or  2  wherein step (b) comprises or consists of measuring the presence and/or amount in the test sample of one or more of the biomarkers defined in Table 1F, for example, two of the biomarkers defined in Table 1F. 
     
     
         9 . The method according to  claim 1  or  2  wherein step (b) comprises or consists of measuring the presence and/or amount in the test sample of one or more of the biomarkers defined in Table 1G, for example, two of the biomarkers defined in Table 1G. 
     
     
         10 . The method according to  claim 1  or  2  wherein step (b) comprises or consists of measuring the presence and/or amount in the test sample of one or more of the biomarkers defined in Table 1H, for example, 2, 3 or 4 of the biomarkers defined in Table 1H. 
     
     
         11 . The method according to  claim 1  or  2  wherein step (b) comprises or consists of measuring the presence and/or amount in the test sample of the biomarker defined in Table 1I. 
     
     
         12 . The method according to  claim 1 ,  2 ,  3 ,  4 ,  5 ,  6 ,  7  and/or  11  wherein the method is for diagnosing Systemic Lupus Erythematosus in an individual; and 
       wherein the presence and/or amount in the test sample of the one or more biomarker(s) selected from the group defined in Table 1 is indicative of whether the individual has Systemic Lupus Erythematosus. 
     
     
         13 . The method according to  claim 12  wherein step (b) comprises or consists of measuring the presence and/or amount in the test sample of all of the biomarkers defined in Table 1A, Table 1B, Table 1C, Table 1D, Table 1E and/or Table 1I. 
     
     
         14 . The method according to  claim 1 ,  2 ,  3 ,  4 ,  5 ,  6 ,  8  and/or  11  wherein the method is for characterising Systemic Lupus Erythematosus in an individual; and 
       wherein the presence and/or amount in the test sample of the one or more biomarker(s) selected from the group defined in Table 1 is indicative of whether the individual has Systemic Lupus Erythematosus subtype 1 (SLE-1), Systemic Lupus Erythematosus subtype 2 (SLE-2) or Systemic Lupus Erythematosus subtype 3 (SLE-3). 
     
     
         15 . The method according to  claim 14  wherein step (b) comprises or consists of measuring the presence and/or amount in the test sample of all of the biomarkers defined in Table 1A, Table 1B, Table 1C, Table 1D, Table 1F and/or Table 1I. 
     
     
         16 . The method according to  claim 1 ,  2 ,  3 ,  4 ,  5 ,  7 ,  8  and/or  9  wherein the method is for prognosing Systemic Lupus Erythematosus in an individual; 
       wherein the sample to be tested in step (b) is a blood or serum sample; and 
       wherein the presence and/or amount in the test sample of the one or more biomarker(s) selected from the group defined in Table 1 is indicative of the prognosis of the Systemic Lupus Erythematosus in the individual. 
     
     
         17 . The method according to  claim 16  wherein step (b) comprises or consists of measuring the presence and/or amount in the test sample of all of the biomarkers defined in Table 1A, Table 1B, Table 1C, Table 1E, Table 1F and/or Table 1G. 
     
     
         18 . The method according to  claim 1 ,  2 ,  3 ,  4 ,  6 ,  7 ,  8 ,  9  and/or  10  wherein the method is for prognosing Systemic Lupus Erythematosus in an individual; and 
       wherein the sample to be tested in step (b) is a urine sample, and 
       wherein the presence and/or amount in the test sample of the one or more biomarker(s) selected from the group defined in Table 1 is indicative of the prognosis of the Systemic Lupus Erythematosus in the individual. 
     
     
         19 . The method according to  claim 18  wherein step (b) comprises or consists of measuring the presence and/or amount in the test sample of all of the biomarkers defined in Table 1A, Table 1B, Table 1D, Table 1E, Table 1F, Table 1G and/or Table 1H. 
     
     
         20 . The method according to any one of  claims 2  to  19  wherein the control sample of step (c) is provided from a healthy individual or an individual with Systemic Lupus Erythematosus. 
     
     
         21 . The method according to  claim 20  wherein the control sample of step (c) is provided from an individual with active (i.e. flaring) Systemic Lupus Erythematosus. 
     
     
         22 . The method according to  claim 20  wherein the control sample of step (c) is provided from an individual with moderate (i.e. neither flaring nor non-flaring) Systemic Lupus Erythematosus. 
     
     
         23 . The method according to  claim 20  wherein the control sample of step (c) is provided from an individual with passive/remissive (i.e. non-flaring) Systemic Lupus Erythematosus. 
     
     
         24 . The method according to any one of  claims 20  to  23  wherein the control sample of step (c) is provided from an individual with Systemic Lupus Erythematosus subtype 1 (SLE-1), Systemic Lupus Erythematosus subtype 2 (SLE-2) or Systemic Lupus Erythematosus subtype 3 (SLE-3). 
     
     
         25 . The method according to any one of the preceding claims wherein step (b) and/or step (d) is performed using a first binding agent capable of binding to the one or more biomarker(s). 
     
     
         26 . The method according to  claim 25  wherein the first binding agent is an antibody or a fragment thereof. 
     
     
         27 . The method according to  claim 26  wherein the antibody or fragment thereof is a recombinant antibody or fragment thereof. 
     
     
         28 . The method according to  claim 26  or  27  wherein the antibody or fragment thereof is selected from the group consisting of: scFv; Fab; a binding domain of an immunoglobulin molecule. 
     
     
         29 . The method according to any one of the preceding claims wherein the one or more biomarker(s) in the test sample is labelled with a detectable moiety. 
     
     
         30 . The method according to any one of  claims 2  to  29  wherein the one or more biomarker(s) in the control sample is labelled with a detectable moiety. 
     
     
         31 . The method according to  claim 29  or  30  wherein the detectable moiety is selected from the group consisting of: a fluorescent moiety, a luminescent moiety, a chemiluminescent moiety, a radioactive moiety, and an enzymatic moiety. 
     
     
         32 . The method according to any one of the preceding claims wherein step (b) is performed using an array. 
     
     
         33 . The method according to any one of the  claims 2  to  32  wherein step (d) is performed using an array. 
     
     
         34 . The method according to  claim 32  or  33  wherein the array is a bead-based array. 
     
     
         35 . The method according to  claim 32  or  33  wherein the array is a surface-based array. 
     
     
         36 . The method according to  claim 32  or  33  wherein the array is selected from the group consisting of macroarray, microarray and nanoarray. 
     
     
         37 . The method according to  claim 1  wherein step (b) is performed using an assay comprising a second binding agent capable of binding to the one or more proteins, the second binding agent having a detectable moiety. 
     
     
         38 . The method according to any one of  claims 2  to  31  wherein step (d) is performed using an assay comprising a second binding agent capable of binding to the one or more proteins, the second binding agent having a detectable moiety. 
     
     
         39 . The method according to  claim 37  or  38  wherein the second binding agent is an antibody or a fragment thereof. 
     
     
         40 . The method according to  claim 39  wherein the antibody or fragment thereof is a recombinant antibody or fragment thereof. 
     
     
         41 . The method according to  claim 39  or  40  wherein the antibody or fragment thereof is selected from the group consisting of scFv, Fab and a binding domain of an immunoglobulin molecule. 
     
     
         42 . The method according to any one of  claims 38  to  41  wherein the detectable moiety is selected from the group consisting of a fluorescent moiety, a luminescent moiety, a chemiluminescent moiety, a radioactive moiety and an enzymatic moiety. 
     
     
         43 . The method according to any one of  claims 37  to  42  wherein the assay is an ELISA (Enzyme Linked immunosorbent Assay). 
     
     
         44 . The method according to any one of  claims 1  to  13  or any one of  claims 20  to  43 , wherein step (b) comprises or consists of measuring the presence and/or amount in the test sample of C1s, C5, GLP-1, IL-10, IL-12, IL-18, IL-1a, IL-3, IL-5, IL-8 INF-gamma, LDL, procathepsin and TNF-alpha. 
     
     
         45 . The method according to any one of  claims 1  to  13  or any one of  claims 20  to  43 , wherein step (b) comprises or consists of measuring the presence and/or amount in the test sample of C3, C4, CD40, GLP-1, IL-12, IL-13, IL-1 alpha, IL-3, Procathepsin, Properdin, TGF-beta1, TNF-alpha and VEGF. 
     
     
         46 . The method according to any one of  claims 1  to  13  or any one of  claims 20  to  43 , wherein step (b) comprises or consists of measuring the presence and/or amount in the test sample of the biomarkers listed in Table 2A, Table 2B, Table 2C, Table 2D, Table 2E, Table 2F, Table 2G, Table 2H, Table 2I, Table 2J and/or Table 2K. 
     
     
         47 . The method according to any one of  claims 1  to  13  or any one of  claims 20  to  43 , wherein step (b) comprises or consists of measuring the presence and/or amount in the test sample of the biomarkers listed in Table 3A, Table 3B, Table 3C, Table 3D, Table 3E, Table 3F, Table 3G, Table 3H, Table 3I, Table 3J, Table 3K, Table 3L, Table 3M, Table 3N, Table 3O, Table 3P, Table 3Q, Table 3R, Table 3S, Table 3T or Table 3U. 
     
     
         48 . The method according to any one of  claims 1  to  13  or any one of  claims 19  to  42 , wherein step (b) comprises or consists of measuring the presence and/or amount in the test sample of the biomarkers listed in Table 4A, Table 4B Table 4C or Table 4D. 
     
     
         49 . An array for determining a Systemic Lupus Erythematosus-associated disease state in an individual comprising one or more binding agent as defined in any one of  claims 25 - 28 . 
     
     
         50 . An array according to  claim 49  wherein the array is for use in a method according to any one of  claims 1 - 48 . 
     
     
         51 . An array according to  claim 49  or  50  wherein the array is for use in a method according to any one of  claim 1 - 24  or  44 - 48 . 
     
     
         52 . An array according to  claim 49 ,  50  or  51  wherein the array is as defined in any one of  claims 32 - 36 . 
     
     
         53 . An array according to any one of  claims 49 - 52  wherein the one or more binding agent is capable of binding to all of the proteins defined in Table 1. 
     
     
         54 . Use of one or more biomarkers selected from the group defined in Table 1 as a biomarker for determining a Systemic Lupus Erythematosus-associated disease state in an individual. 
     
     
         55 . The use according to  claim 54  wherein all of the biomarkers defined in Table 1 are used as a biomarker for determining a Systemic Lupus Erythematosus-associated disease state in an individual. 
     
     
         56 . A kit for determining a Systemic Lupus Erythematosus-associated disease state in an individual comprising:
 i) one or more first binding agent as defined in any one of  claims 25  to  28  or an array according to  claims 49  and  50 ,   ii) instructions for performing the method as defined in any one of  claims 1  to  36 .   
     
     
         57 . A kit for determining a Systemic Lupus Erythematosus-associated disease state in an individual comprising:
 i) one or more second binding agent as defined in any one of  claim 22  or  37 - 41 ,   ii) instructions for performing the method as defined in any one of  claims 1  to  36 .   
     
     
         58 . A method or use substantially as described herein. 
     
     
         59 . An array or kit substantially as described herein.

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