Hepcidins as Biomarkers for Impending Lupus Nephritis Flare
First Claim
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1. A method for predicting a subject'"'"'s risk for a kidney flare episode, the method comprising detecting the status of one or more subject-derived hepcidin-20 and hepcidin-25 biomarkers in a sample taken from the subject.
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Abstract
Biomarkers for determining a kidney flare episode in systemic lupus erythematosus are described.
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Citations
35 Claims
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1. A method for predicting a subject'"'"'s risk for a kidney flare episode, the method comprising detecting the status of one or more subject-derived hepcidin-20 and hepcidin-25 biomarkers in a sample taken from the subject.
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2. A method of analyzing a subject sample for one or more subject-derived markers selected to identify at least a beginning of a kidney flare episode in a patient suffering from systemic lupus erythematosus (SLE), comprising:
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assaying the sample for the presence or amount of one or more subject-derived hepcidin-20 and hepcidin-25 markers related to a kidney flare episode, and characterizing the subject'"'"'s risk of having or the kidney flare episode disorders based upon the presence or amount of the hepcidin-20 and hepcidin-25 marker. - View Dependent Claims (3, 7, 8, 9, 10, 11)
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4. (canceled)
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5. (canceled)
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6. (canceled)
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12. A method for assigning a therapy regimen and/or assigning a prognosis to a subject diagnosed with or suspected of suffering from systemic lupus erythematosus, comprising:
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performing an assay method on a sample obtained from the subject, wherein the assay method provides one or more detectable signals related to the presence or amount of one or more subject-derived hepcidin-20 and hepcidin-25 markers; and correlating the signal(s) obtained from the assay method to ruling in or out a therapy regimen for the subject and/or assigning a prognosis to the subject. - View Dependent Claims (13, 14, 15, 16, 17, 19, 20, 21, 22, 23)
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18. (canceled)
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24. A diagnostic method, comprising:
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determining a concentration of at least one of a hepcidin-20 or hepcidin-25 marker in a bodily fluid sample from a subject suffering from systemic lupus erythematosus, wherein an increase in hepcidin-20 or hepcidin-25 concentration in the bodily fluid sample relative to a threshold hepcidin-20 or hepcidin-25 concentration indicates a kidney flare episode is likely to occur in the subject, and wherein lack of an increase in hepcidin-20 or hepcidin-25 concentration in the bodily fluid sample relative to a threshold hepcidin-20 or hepcidin-25 concentration indicates a kidney flare episode is not likely to occur in the subject. - View Dependent Claims (25, 26, 27, 28)
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29. A method for diagnosing a disease condition characterized by non-physiological levels of at least one of hepcidin-20 or hepcidin-25, comprising:
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obtaining a tissue or fluid sample from a subject; contacting the sample with an antibody or fragment thereof that specifically binds to one or more binding sites on hepcidin-20 and/or hepcidin-25, and quantifying hepcidin-20 and/or hepcidin-25 level in the sample;
wherein the non-physiological level of hepcidin-20 and/or hepcidin-25 is indicative of the disease condition. - View Dependent Claims (30, 31)
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- 32. A kit for detecting a disease condition characterized by non-physiological levels of one or more subject-derived hepcidin-20 and hepcidin-25 markers, comprising, an anti-hepcidin antibody or fragment thereof that specifically binds to one or more mid-portion or carboxy terminal epitopes of hepcidin, and a reagent that binds directly or indirectly to the antibody or fragment thereof.
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35. A method of analyzing a subject sample for one or more subject-derived hepcidin-20 and hepcidin-25 markers selected to identify at least a beginning of a kidney flare episode in a patient suffering from systemic lupus erythematosus, comprising:
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assaying the sample for the presence or amount of one or more subject-derived hepcidin-20 and hepcidin-25 markers related to a kidney flare-up episode, wherein the markers comprise the up-regulation of hepcidin-20 at least as early as four months prior to onset of symptomatic indications of a kidney nephritis flare-up episode, and wherein the down regulation of hepcidin-25 at least as early as two months prior to onset of symptomatic indications of a kidney nephritis flare-up episode, and characterizing the subject'"'"'s risk of having or the kidney flare episode disorders based upon the presence or amount of the marker, wherein the amount of at least one of the one or more subject-derived markers is not compared to a predetermined threshold amount.
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Specification