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.

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 - 15 . (canceled) 
     
     
         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 1 , wherein periostin is detected in an assay wherein the periostin becomes labeled with a detectable label. 
     
     
         19 . The method of  claim 1 , wherein periostin is detected in an assay wherein the periostin is transformed from a free state to a bound state by forming a complex with another assay component. 
     
     
         20 . The method of  claim 1 , wherein periostin is detected in an assay wherein periostin initially present in a soluble phase becomes immobilized on a solid phase. 
     
     
         21 . The method of  claim 1 , wherein periostin is detected in an assay wherein the sample is fractionated to separate periostin from at least one other sample component. 
     
     
         22 . The method of  claim 1 , wherein periostin is detected in an assay wherein periostin becomes embedded in a separation medium. 
     
     
         23 . The method of  claim 1 , wherein periostin is detected in an assay wherein periostin is volatilized. 
     
     
         24 . The method of  claim 1 , additionally comprising recording the periostin level, and/or a diagnosis based at least in part on the periostin level, in a patient medical record. 
     
     
         25 . The method of  claim 24 , wherein said recording comprises recording the periostin level in a computer-readable medium. 
     
     
         26 . The method of  claim 24 , wherein said patient medical record is maintained by a laboratory, physician's office, a hospital, a health maintenance organization, an insurance company, or a personal medical record website. 
     
     
         27 . The method of  claim 1 , wherein a diagnosis, based at least in part on the periostin level, is recorded on or in a medic alert article selected from a card, worn article, or radiofrequency identification (RFID) tag. 
     
     
         28 . The method of  claim 1 , additionally comprising informing the subject of a result of the periostin assay and/or of a diagnosis based at least in part on the periostin level. 
     
     
         29 . The method of  claim 1 , additionally comprising prescribing, initiating, and/or altering prophylaxis and/or therapy. 
     
     
         30 . The method of  claim 1 , additionally comprising ordering and/or performing one or more additional assays. 
     
     
         31 . The method of  claim 30 , wherein the periostin level determined in said assay is not elevated, and the additional assay comprises an additional periostin assay. 
     
     
         32 . The method of  claim 30 , wherein the periostin level determined in said assay is elevated. 
     
     
         33 . The method of  claim 32 , wherein the additional assay comprises an additional periostin assay. 
     
     
         34 . The method of  claim 32 , wherein the additional assay comprises a different assay. 
     
     
         35 . The method of  claim 1 , wherein periostin is detected as part of a differential diagnosis.