Methods of determining an increased risk of a woman carrying a Downs syndrome affected fetus by measuring an analyte in a biological sample

Abstract

There are provided methods for assaying biological specimens for one or more of leptin, prorenin or renin in order to provide predictive information about the likelihood of a woman carrying a Downs Syndrome affected fetus.

What is claimed is:  
     
         1 . A method of determining an increased risk of a woman carrying a Downs Syndrome affected fetus, the method comprising the steps of: 
 a) quantitatively assaying a sample from a pregnant woman for an amount of leptin in the sample, thereby determining the amount of leptin in the sample; and    b) comparing the amount of leptin in the sample in step a with an amount of leptin found in pregnant women carrying a Downs syndrome unaffected fetus and comparing the amount of leptin in the sample in step a with an amount of leptin found in pregnant women carrying a Downs syndrome affected fetus, thereby determining those at an increased risk of carrying a Downs syndrome affected fetus.    
     
     
         2 . The method of  claim 1  wherein the amount of leptin in the sample as determined in step a is below the median amount of leptin found in a pregnant women carrying a Downs syndrome unaffected fetus.  
     
     
         3 . The method of  claim 1  wherein the sample from the pregnant women is selected from the group consisting of serum, plasma or urine.  
     
     
         4 . The method of  claim 1  wherein the sample is taken from a pregnant women in either of the first or the second or the third trimester of pregnancy.  
     
     
         5 . The method of  claim 1  wherein the quantitative assay of the sample is performed by immunoassay.  
     
     
         6 . The method of  claim 1  further comprising the step of analyzing at least one additional analyte selected from the group consisting of hCG, unconjugated estriol, alpha-fetoprotein, inhibin, PAPP-A, progesterone, DHEA-S or Leukocyte acid phosphatase.  
     
     
         7 . The method of  claim 1  further comprising the step of analyzing at least one additional analyte predictive of an increased risk of a fetus being affected by Downs syndrome.  
     
     
         8 . The method of  claim 1  further comprising the step of analyzing at least one additional factor predictive of an increased risk of a fetus being affected by Downs syndrome.  
     
     
         9 . The method of  claim 8  wherein the additional factor is an ultrasound result.  
     
     
         10 . A method of determining an increased risk of a woman carrying a Downs Syndrome affected fetus, the method comprising the steps of: 
 a) quantitatively assaying a sample from a pregnant woman for an amount of prorenin in the sample, thereby determining the amount of prorenin in the sample; and    b) comparing the amount of prorenin in the sample in step a with an amount of prorenin found in pregnant women carrying a Downs syndrome unaffected fetus and comparing the amount of prorenin in the sample in step a with an amount of prorenin found in pregnant women carrying a Downs syndrome affected fetus, thereby determining those at an increased risk of carrying a Downs syndrome affected fetus.    
     
     
         11 . The method of  claim 10  wherein the amount of prorenin in the sample as determined in step a is below the median amount of prorenin found in a pregnant women carrying a Downs syndrome unaffected fetus.  
     
     
         12 . The method of  claim 10  wherein the sample from the pregnant women is selected from the group consisting of serum, plasma or urine.  
     
     
         13 . The method of  claim 10  wherein the sample is taken from a pregnant women in either of the first trimester or the second trimester or the third trimester of pregnancy.  
     
     
         14 . The method of  claim 10  wherein the quantitative assay of the sample is performed by immunoassay.  
     
     
         15 . The method of  claim 10  further comprising the step of analyzing at least one additional analyte predictive of an increased risk of a fetus being affected by Downs syndrome.  
     
     
         16 . A method of determining an increased risk of a woman carrying a Downs Syndrome affected fetus, the method comprising the steps of: 
 a) quantitatively assaying a sample from a pregnant woman for an amount of renin in the sample, thereby determining the amount of renin in the sample; and    b) comparing the amount of renin in the sample in step a with an amount of renin found in pregnant women carrying a Downs syndrome unaffected fetus and comparing the amount of renin in the sample in step a with an amount of renin found in pregnant women carrying a Downs syndrome affected fetus, thereby determining those at an increased risk of carrying a Downs syndrome affected fetus.    
     
     
         17 . The method of  claim 16  wherein the amount of renin in the sample as determined in step a is below the median amount of renin found in a pregnant women carrying a Downs syndrome unaffected fetus.  
     
     
         18 . The method of  claim 16  wherein the sample from the pregnant women is selected from the group consisting of serum, plasma or urine.  
     
     
         19 . The method of  claim 16  wherein the sample is taken from a pregnant women in either of the first trimester or the second trimester or the third trimester of pregnancy.  
     
     
         20 . The method of  claim 16  wherein the quantitative assay of the sample is performed by immunoassay.  
     
     
         21 . A method of determining whether there is an increased risk of a woman carrying a fetus which is affected by Downs Syndrome, the method comprising the steps of: 
 a) quantitatively assaying a sample from a pregnant woman for an amount of leptin in the sample, thereby determining the amount of leptin in the sample;    b) comparing the amount of leptin in the sample in step a with an amount of leptin found in pregnant women carrying a Downs syndrome unaffected fetus and comparing the amount of leptin in the sample in step a with an amount of leptin found in pregnant women carrying a Downs syndrome affected fetus,    c) quantitatively assaying a sample from a pregnant woman for an amount of prorenin in the sample, thereby determining the amount of prorenin in the sample; and    d) comparing the amount of prorenin in the sample in step a with an amount of prorenin found in pregnant women carrying a Downs syndrome unaffected fetus and comparing the amount of prorenin in the sample in step a with an amount of prorenin found in pregnant women carrying a Downs syndrome affected fetus, thereby determining those at an increased risk of carrying a Downs syndrome affected fetus.    
     
     
         22 . The method of  claim 21  wherein the sample from the pregnant women is selected from the group consisting of serum, plasma or urine.  
     
     
         23 . The method of  claim 21  wherein the sample is taken from a pregnant women in either of the first trimester or the second trimester or the third trimester of pregnancy.  
     
     
         24 . The method of  claim 21  wherein the quantitative assay of the sample is performed by immunoassay.  
     
     
         25 . The method of  claim 21  further comprising the step of analyzing at least one additional analyte predictive of an increased risk of a fetus being affected by Downs syndrome.  
     
     
         26 . A method of determining whether there is an increased risk of a woman carrying a fetus which is affected by Downs Syndrome, the method comprising the steps of: 
 b) quantitatively assaying a sample from a pregnant woman for an amount of renin in the sample, thereby determining the amount of renin in the sample;    b) comparing the amount of renin in the sample in step a with an amount of renin found in pregnant women carrying a Downs syndrome unaffected fetus and comparing the amount of renin in the sample in step a with an amount of renin found in pregnant women carrying a Downs syndrome affected fetus,    c) quantitatively assaying a sample from a pregnant woman for an amount of prorenin in the sample, thereby determining the amount of prorenin in the sample; and    d) comparing the amount of prorenin in the sample in step a with an amount of prorenin found in pregnant women carrying a Downs syndrome unaffected fetus and comparing the amount of prorenin in the sample in step a with an amount of prorenin found in pregnant women carrying a Downs syndrome affected fetus, thereby determining those at an increased risk of carrying a Downs syndrome affected fetus.    
     
     
         27 . The method of  claim 26  wherein the sample from the pregnant women is selected from the group consisting of serum, plasma or urine.  
     
     
         28 . The method of  claim 26  wherein the sample is taken from a pregnant women in either of the first trimester or the second trimester or the third trimester of pregnancy.  
     
     
         29 . The method of  claim 26  wherein the quantitative assay of the sample is performed by immunoassay.  
     
     
         30 . The method of  claim 26  further comprising the step of analyzing at least one additional analyte predictive of an increased risk of a fetus being affected by Downs syndrome.