Biomarkers for Diagnosing Liver Disease

Abstract

The present invention provides biomarkers and a method for diagnosing a liver disease in a subject such as steatosis, inflammatory liver disease, NASH, and NAFLD. The invention also relates to tools for carrying out the aforementioned methods, such as diagnostic devices.

1 . A method for differentiating between NASH and NAFLD in a subject comprising:
 (a) determining in a sample of a subject suspected to suffer from either NASH or NAFLD the amount of at least one biomarker from Tables 5A or 5B; and   (b) comparing the said amount of the at least one biomarker with a reference, whereby it is differentiated whether the subject suffers from NASH or NAFLD.   
     
     
         2 . The method of  claim 1 , wherein said reference is derived from a subject known to suffer from NAFLD. 
     
     
         3 . The method of  claim 2 , wherein the at least one biomarker is from Table 5A and wherein an increased amount with respect to the reference is indicative for NASH. 
     
     
         4 . The method of  claim 2 , wherein the at least one biomarker is from Table 5B and wherein a decreased amount with respect to the reference is indicative for NASH. 
     
     
         5 . The method of  claim 1 , wherein said reference is derived from a subject known to suffer from NASH. 
     
     
         6 . The method of  claim 5 , wherein the at least one biomarker is from Table 5A and wherein a decreased amount with respect to the reference is indicative for NAFLD. 
     
     
         7 . The method of  claim 5 , wherein the at least one biomarker is from Table 5B and wherein an increased amount with respect to the reference is indicative for NAFLD. 
     
     
         8 . A device for determining in a sample of a subject whether the subject to be analysed suffers from either NAFLD or NASH comprising:
 (a) an analyzing unit for the said sample of the subject comprising a detector for at least one biomarker from Tables 5A or 5B said detector allowing for the determination of the amount of the said at least one biomarker in the sample; and operatively linked thereto,   (b) an evaluation unit comprising a data processing unit and a data base, said data base comprising a stored reference as defined in claim  12  for the at least one biomarker, and said data processing unit being capable of (i) carrying out a comparison of the amount of the at least one biomarker determined by the analyzing unit and the stored reference and (ii) generating an output information based on which the determination can be established.