Use of hematopoietic growth factor inducible neurokinin-1 (hgfin) 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 hematopoietic growth factor inducible neurokinin-1 (HGFIN), wherein the presence of HGFIN at an elevated level indicates the presence and/or degree of renal injury or renal disease, and/or the rate of loss of renal function. In other embodiments, the invention provides a method of detecting an indicator of systemic inflammation. This method entails assaying a biological sample for HGFIN, wherein the presence of HGFIN at an elevated level indicates the presence and/or degree of systemic inflammation. 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 systemic inflammation, the method comprising assaying a biological sample for hematopoietic growth factor inducible neurokinin-1 (HGFIN), wherein the presence of leukocyte HGFIN at an elevated level indicates the presence and/or degree of systemic inflammation. 
     
     
         2 . The method of  claim 1 , wherein the biological sample comprises a blood sample, a plasma sample and/or a serum sample. 
     
     
         3 . The method of  claim 2 , wherein the blood sample comprises blood monocytes and/or macrophages. 
     
     
         4 . The method of  claim 2 , wherein the biological sample is from a human. 
     
     
         5 . The method of  claim 4 , wherein the human is a human patient known to have, or suspected of having, an inflammatory disease. 
     
     
         6 . The method of  claim 1  additionally comprising detecting one or more additional indicators of inflammatory disease. 
     
     
         7 . The method of  claim 1 , wherein HGFIN is detected by a method selected from the group consisting of an immunoassay, electrophoresis, chromatography, and mass spectroscopy. 
     
     
         8 . A method of detecting an indicator of a subject's response to treatment for an inflammatory disease, the method comprising assaying a biological sample obtained from a subject after initiation of treatment for inflammatory disease for hematopoietic growth factor inducible neurokinin-1 (HGFIN), wherein the level of HGFIN is positively correlated with the degree of inflammatory disease. 
     
     
         9 - 18 . (canceled) 
     
     
         19 . A method of detecting an indicator of a subject's susceptibility to diseases characterized by systemic inflammation, the method comprising assaying a biological sample for hematopoietic growth factor inducible neurokinin-1 (HGFIN), wherein the presence of HGFIN at an elevated level indicates the susceptibility to a disease characterized by systemic inflammation. 
     
     
         20 - 23 . (canceled) 
     
     
         24 . The method of  claim 1 , wherein HGFIN is detected in an assay wherein the HGFIN becomes labeled with a detectable label. 
     
     
         25 . The method of  claim 1 , wherein HGFIN is detected in an assay wherein the HGFIN is transformed from a free state to a bound state by forming a complex with another assay component. 
     
     
         26 . The method of  claim 1 , wherein HGFIN is detected in an assay wherein HGFIN initially present in a soluble phase becomes immobilized on a solid phase. 
     
     
         27 . The method of  claim 1 , wherein HGFIN is detected in an assay wherein the sample is fractionated to separate HGFIN from at least one other sample component. 
     
     
         28 . The method of  claim 1 , wherein HGFIN is detected in an assay wherein HGFIN becomes embedded in a separation medium. 
     
     
         29 . The method of  claim 1 , wherein HGFIN is detected in an assay wherein HGFIN is volatilized. 
     
     
         30 . The method of  claim 1 , additionally comprising recording the HGFIN level, and/or a diagnosis based at least in part on the HGFIN level, in a patient medical record. 
     
     
         31 . The method of  claim 30 , wherein said recording comprises recording the HGFIN level in a computer-readable medium. 
     
     
         32 . The method of  claim 30 , 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. 
     
     
         33 . The method of  claim 1 , wherein a diagnosis, based at least in part on the HGFIN level, is recorded on or in a medic alert article selected from a card, worn article, or radiofrequency identification (RFID) tag. 
     
     
         34 . The method of  claim 1 , additionally comprising informing the subject of a result of the HGFIN assay and/or of a diagnosis based at least in part on the HGFIN level. 
     
     
         35 . The method of  claim 1 , additionally comprising prescribing, initiating, and/or altering prophylaxis and/or therapy. 
     
     
         36 . The method of  claim 1 , additionally comprising ordering and/or performing one or more additional assays. 
     
     
         37 . The method of  claim 36 , wherein the HGFIN level determined in said assay is not elevated, and the additional assay comprises an additional HGFIN assay. 
     
     
         38 . The method of  claim 36 , wherein the HGFIN level determined in said assay is elevated. 
     
     
         39 . The method of  claim 38 , wherein the additional assay comprises an additional HGFIN assay. 
     
     
         40 . The method of  claim 38 , wherein the additional assay comprises a different assay. 
     
     
         41 . The method of  claim 1 , wherein HGFIN is detected as part of a differential diagnosis.