# US 7,411,048 B2 · Diagnostic method for diseases by screening for hepcidin in human or animal tissues, blood or body fluids > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 7,411,048 B2 - Document ID: US7411048B2 - Status: Granted - Kind: B2 - Application number: 10/299,486 - Filed: 2002-11-19 - Published: 2004-05-20 - Granted: 2008-08-12 - Earliest claimed: 2002-11-19 - Assignees: DRG International, Inc. - Inventors: Hasan Kulaksiz; Cyril E. Geacintov; Alfred Janetzko; Wolfgang Stremmel - Web page: https://patentgrep.com/patent/US7411048B2 ## CPC - C07K 16/26: against hormones {; against hormone releasing or inhibiting factors} - C07K 16/2881: {against CD71} - G01N 33/68: involving proteins, peptides or amino acids {(involving lipoproteins G01N33/92)} - G01N 33/6878: {in epitope analysis} - C07K 2317/34: Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues - Y10S 435/975: Kit - C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00) - G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q) - Y10S: TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS ## Abstract The present invention concerns methods and kits for diagnosing a disease condition characterized by non-physiological levels of hepcidin, comprising obtaining a tissue or fluid sample from a subject; contacting the sample with an antibody or fragment thereof that specifically binds to a polypeptide corresponding to the mid-portion or C terminus of a hepcidin protein, and quantifying the hepcidin level using an assay based on binding of the antibody and the polypeptide; wherein the non-physiological level of hepcidin is indicative of the disease condition. The present invention also concerns diagnostic methods and kits for applications in genetic technological approaches, such as for overexpressing or downregulating hepcidin. The present invention further concerns therapeutic treatment of certain diseases by treatment of subjects with hepcidin and agonists or antagonists of hepcidin. ## Claims ### Claim 1 A kit for detecting a disease condition characterized by non-physiological levels of hepcidin, comprising, an anti-hepcidin antibody or fragment thereof that specifically binds to one or more epitopes of hepcidin located within an amino acid sequence consisting of SEQ ID NO: 3, and a reagent that binds directly or indirectly to the antibody or fragment thereof, wherein the antibody or fragment thereof is capable of detecting less than about 50 ng of a protein consisting of SEQ. ID. NO. 3, and wherein the antibody or fragment thereof detects by Western blot analysis, an amino acid sequence consisting of amino acids 25-84 of SEQ ID NO: 2 in a tissue or a liquid sample obtained from a patient. ### Claim 2 (depends on 1) The kit of claim 1 wherein the anti-hepcidin antibody or fragment thereof is immobilized on a support. ### Claim 3 (depends on 1) The kit of claim 1 wherein the reagent comprises hepcidin complexed with a first binding molecule. ### Claim 4 (depends on 3) The kit of claim 3 wherein the first binding molecule is biotin. ### Claim 5 (depends on 4) The kit of claim 4 wherein the kit further comprises an enzyme complexed with a second binding molecule and a substrate of the enzyme. ### Claim 6 (depends on 5) The kit of claim 5, wherein the second binding molecule is streptavidin. ### Claim 7 (depends on 5) The kit of claim 5, wherein the enzyme is horse radish peroxidase, and the substrate comprises peroxide. ### Claim 8 An isolated antibody or fragment thereof that specifically binds to one or more epitopes of hepcidin located within an amino acid sequence consisting of SEQ ID NO: 3, wherein the antibody or fragment thereof is capable of detecting less than about 50 ng of a protein consisting of SEQ. ID. NO. 3, and wherein the antibody or fragment thereof detects by Western blot analysis, an amino acid sequence consisting of amino acids 25-84 of SEQ ID NO: 2 in a tissue or a liquid sample obtained from a patient. ### Claim 9 (depends on 1) The kit of claim 1, wherein the antibody or fragment thereof is capable of detecting at least about 0.1 ng of the protein consisting of SEQ. ID. NO. 3. ### Claim 10 (depends on 8) The isolated antibody of claim 8, wherein the antibody or fragment thereof is capable of detecting at least about 0.1 ng of the protein consisting of SEQ. ID. NO.3. ### Claim 11 An isolated antibody or a fragment thereof that specifically binds to one or more epitopes of hepcidin located within an amino acid sequence consisting of SEQ ID NO: 3, wherein the antibody or fragment thereof detecting detects by Western blot analysis, an amino acid sequence consisting of amino acids 25-84 of SEQ ID NO: 2 in a tissue or a liquid sample obtained from a patient. ### Claim 12 (depends on 11) The isolated antibody of claim 11, wherein the tissue or the liquid sample obtained from the patient is serum. ### Claim 13 A kit for detecting a disease condition characterized by non-physiological levels of hepcidin, comprising, an anti-hepcidin antibody or fragment thereof that specifically binds to one or more epitopes of hepcidin located within an amino acid sequence consisting of SEQ ID NO: 3, wherein the antibody or fragment thereof detects by Western blot analysis, an amino acid sequence consisting of amino acids 25-84 of SEQ ID NO: 2 in a tissue or a liquid sample derived from a patient. ### Claim 14 (depends on 13) The isolated antibody of claim 13, wherein the tissue or the liquid sample obtained from the patient is serum.