A new biomarker for preeclampsia

Abstract

This invention relates to the use of biomarker LRG1 as a biomarker for preeclampsia for use from the first trimester. Elevated levels of leucine-rich alpha 2 glycoprotein 1 (LRG1) can predict risk for the future development of preeclampsia or other hypertensive disorders of pregnancy. The predictive test will comprise the measurement of LRG1 protein, peptide fragment, DNA or RNA, from either blood, plasma, serum, urine, saliva or amniotic fluid. The invention provides a method and a test kit to assess the risk of pre-eclampsia in pregnant woman. The method or test can utilise antibodies to measure levels of LGR1 in a sample.

1 . An in vitro method for assessing the risk of preeclampsia in a subject, comprising detecting a level of LRG1 in a biological sample from said subject, wherein an elevated LRG1 level is indicative of risk of hypertensive disorders of pregnancy. 
     
     
         2 . A method as claimed in  claim 1  wherein the disorder is pre-eclampsia. 
     
     
         3 . A method as claimed in  claim 1  wherein the method comprises the steps of
 obtaining a biological sample from the subject; and 
 detecting a level of LRG1 in the biological sample; 
 wherein an elevation in the detected level of LRG1 in the biological sample relative to a control value indicates that the subject is at increased risk of preeclampsia. 
 
     
     
         4 . The method of  claim 1 , wherein the biological sample is whole blood, serum, plasma, urine, saliva or amniotic fluid. 
     
     
         5 . The method as claimed in  claim 1 , wherein the biological sample is a sample obtained from the subject during a first trimester. 
     
     
         6 . The method as claimed in  claim 1 , wherein the biological sample is a sample obtained from the subject during a second trimester. 
     
     
         7 . The method as claimed in  claim 1 , wherein the biological sample is a sample obtained from the subject during a third trimester. 
     
     
         8 . The method as claimed in  claim 3  wherein the control value is a reference value representative of a level of LRG1 in a sample from a subject who will not develop preeclampsia. 
     
     
         9 . The method as claimed in  claim 3  wherein the control value is a reference value representative of a level of LRG1 in a sample obtained from the same subject prior to pregnancy. 
     
     
         10 . The method of  claim 3 , wherein the elevation in the detected level of LRG1 in the biological sample relative to the control value is at least a 15% elevation. 
     
     
         11 . The method of  claim 3 , wherein the elevation in the detected level of LRG1 in the biological sample relative to the control value is at least a 30% elevation. 
     
     
         12 . The method of  claim 1  wherein the level of LRG1 is measured using an immunoreagent to detect the level of LRG1. 
     
     
         13 . The method of  claim 1 , further comprising detecting said level of LRG1 in said biological sample with a test device comprising:
 a housing   a test strip contained within the housing,   the test strip comprising one or more immunoreagents,   wherein one of the one or more immunoreagents detects the level of LRG1.   
     
     
         14 . The method of  claim 12 , wherein the immunoreagent that measures the level of LRG1 is an anti-LRG1 antibody. 
     
     
         15 . The method of  claim 14 , the test device further comprising means for quantifying binding of the anti-LRG1 antibody to LRG1 in the biological sample. 
     
     
         16 . (canceled) 
     
     
         17 . An antibody to LRG1 for use in an in vitro method for assessment of the risk of pre-eclampsia or another hypertensive disorder in a pregnant woman. 
     
     
         18 . (canceled) 
     
     
         19 . The method of  claim 14 , wherein the antibody binds to epitope regions of LRG1 protein selected from GLKALGHLSGNRLRKL (SEQ ID NO:1) and AGPEAVKGQTLLAVAKSQ (SEQ ID NO:2). 
     
     
         20 . The antibody of  claim 17 , wherein the antibody binds to epitope regions of LRG1 protein selected from GLKALGHLSGNRLRKL (SEQ ID NO:1) and AGPEAVKGQTLLAVAKSQ (SEQ ID NO:2).