Use of periostin as a novel biomarker

Abstract

The invention provides, in certain embodiments, a method of detecting an indicator of renal injury or renal disease. The method entails assaying a urine sample for periostin, wherein the presence of periostin at an elevated level indicates the presence and/or degree of renal injury or renal disease. Also provided, are methods of determining progression of these conditions, as well as methods of determining subjects' response to treatment.

What is claimed is: 
     
         1 . A method of detecting an indicator of renal injury or renal disease, the method comprising assaying a urine sample for periostin, wherein the presence of periostin at an elevated level indicates the presence and/or degree of renal injury or renal disease. 
     
     
         2 . The method of  claim 1 , wherein periostin is detected as an indicator selected from the group consisting of a diagnostic indicator of renal injury or renal disease;
 an indicator of progression, remission, or relapse of renal injury or renal disease; and an indicator of response to treatment for renal injury or renal disease.   
     
     
         3 . The method of  claim 2 , wherein periostin is detected as an indicator of epithelial mesenchymal transition (EMT). 
     
     
         4 . The method of  claim 1 , wherein the urine sample comprises a human urine sample. 
     
     
         5 . The method of  claim 1 , wherein the urine sample comprises centrifuged urine. 
     
     
         6 . The method of  claim 1 , wherein the urine sample comprises urinary exosomes. 
     
     
         7 . The method of  claim 4 , wherein the human is a human patient known to have, or suspected of having, renal injury or renal disease. 
     
     
         8 . The method of  claim 7 , wherein the human patient is known to have, or is suspected of having, renal injury. 
     
     
         9 . The method of  claim 7 , wherein the human patient is known to have, or is suspected of having, acute renal disease. 
     
     
         10 . The method of  claim 7 , wherein the human patient is known to have, or suspected of having, chronic renal disease. 
     
     
         11 . A method of detecting an indicator of a subject's response to treatment for renal injury or renal disease, the method comprising assaying a urine sample obtained from a subject after initiation of treatment for renal injury or renal disease for periostin, wherein the level of periostin is positively correlated with the degree of renal injury or renal disease. 
     
     
         12 . The method of  claim 11 , wherein a baseline level of periostin is measured prior to initiation of treatment for renal injury or renal disease. 
     
     
         13 . The method of  claim 12 , wherein the periostin level of the urine sample after initiation of treatment is compared to the baseline level of periostin. 
     
     
         14 . The method of  claim 13 , wherein a decrease in the periostin level of the urine sample after initiation of treatment, as compared to the baseline level of periostin, indicates that the subject is responding to the treatment. 
     
     
         15 . The method of  claim 13 , wherein one or more additional assays of periostin are performed as treatment is continued. 
     
     
         16 . The method of  claim 1 , additionally comprising detecting one or more additional indicators of renal injury or disease selected from the group consisting of serum creatinine, serum cystatin-C, urine protein, urine albumin, urine N-acetyl-beta-D-glucosaminidase, urine NGAL, IL-18, urine KIM1, and hematopoietic growth factor inducible neurokinin-1 (HGFIN). 
     
     
         17 . The method of  claim 1 , wherein periostin is detected by a method selected from the group consisting of an immunoassay, HPLC, and mass spectroscopy. 
     
     
         18 . The method of  claim 11 , additionally comprising prescribing, initiating, and/or altering prophylaxis and/or therapy. 
     
     
         19 . The method of  claim 1 , additionally comprising ordering and/or performing one or more additional assays. 
     
     
         20 . The method of  claim 19 , wherein the additional assay comprises a different assay.