US2007042426A1PendingUtilityA1

Biomarkers and assays for myocardial infarction

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Individually held — no corporate assignee on recordPriority: Jan 28, 2005Filed: Jan 30, 2006Published: Feb 22, 2007
Est. expiryJan 28, 2025(expired)· nominal 20-yr term from priority
Inventors:Urban A. KiernanDobrin NedelkovRandall W. Nelson
G01N 33/6893G01N 2800/324
49
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Claims

Abstract

Presented herein are novel blood plasma/serum biomarkers related to cardiovascular disease. These newly identified biomarkers create the basis for multiple (single) assays using traditional bioassay technologies and when used in combination yield exceptional clinical sensitivity and specificity in the determination of myocardial infarction (MI). A multiplexed, mass spectrometric immunoassay (MSIA) able to simultaneously assay for the new/novel biomarkers as well other MI markers is also presented. Means and methods for evaluating data generated using multiple biomarkers in order to validate findings and further the use of the multiplexed MI assay in clinical, diagnostic and therapeuatic uses is also included.

Claims

exact text as granted — not AI-modified
1 . A biomarker for at least one of determining, diagnosing and monitoring cardiovascular diseases wherein the biomarker is comprised of at least one of serum amyloid a (SAA) and its variants and transthyretin (TRR) and its variants.  
     
     
         2 . The biomarker of  claim 1  comprising the SAA1α variant of SAA.  
     
     
         3 . The biomarker of  claim 2  wherein the SAA1α variant of SAA is wild-type SAA1α.  
     
     
         4 . The biomarker of  claim 2  wherein the SAA1α variant of SAA contains a point mutation.  
     
     
         5 . The biomarker of  claim 2  wherein the SAA1α variant of SAA contains a posttranslational modification.  
     
     
         6 . The biomarker of  claim 1  comprising a wild-type TTR variant of TTR.  
     
     
         7 . The biomarker of  claim 1  comprising a variant of TTR that comprises a point mutation.  
     
     
         8 . The biomarker of  claim 1  comprising a variant of TTR that comprises a posttranslational modification.  
     
     
         9 . The biomarker of  claim 8  wherein the posttranslational modification comprises oxidation.  
     
     
         10 . The biomarker of  claim 9  wherein the oxidation comprises sulfonation.  
     
     
         11 . The biomarker of  claim 10  wherein the sulfonation occurs on a free cysteine.  
     
     
         12 . The biomarker of  claim 11  wherein the free cysteine is at residue Cys10 of TTR.  
     
     
         13 . A biomarker of  claim 1  wherein the cardiovascular disease is myocardial infarction.  
     
     
         14 . A method for at least one of determining, diagnosing and monitoring a cardiovascular disease which includes the step of analyzing at least one of serum amyloid a (SAA) and its variants and transthyretin (TTR) and its variants.  
     
     
         15 . The method of  claim 14  wherein the step of analyzing at least one of SAA and its variants and TTR and its variants comprises the step of performing mass spectrometry.  
     
     
         16 . The method of  claim 15  further comprising the step of performing affinity isolation prior to performing mass spectrometry.  
     
     
         17 . The method of  claim 16  wherein the step of performing affinity isolation comprises the step of utilizing antibodies for isolation.  
     
     
         18 . The method of  claim 14  wherein the step of analyzing at least one of SAA and its variants and TTR and its variants comprises the step of performing individual assays.  
     
     
         19 . The method of  claim 18  further comprising the step of performing mass spectrometry.  
     
     
         20 . The method of  claim 14  wherein the step of analyzing at least one of SAA and its variants and TTR and its variants comprises the step of performing a single assay.  
     
     
         21 . The method of  claim 20  further comprising the step of performing mass spectrometry.  
     
     
         22 . The method of  claim 14  wherein the step of analyzing at least one of SAA and its variants and TTR and its variants comprises the step of analyzing at least one of SAA and its variants and TTR and its variants in combination with another biomarker.  
     
     
         23 . The method of  claim 22  wherein the step of analyzing at least one of SAA and its variants and TTR and its variants in combination with another biomarker comprises the step of performing mass spectrometry.  
     
     
         24 . The method of  claim 22  wherein the step of analyzing at least one of SAA and its variants and TTR and its variants in combination with another biomarker comprises analyzing at least one of SAA and its variants and TTR and its variants in combination with myoglobin.  
     
     
         25 . The method of  claim 14  wherein the method for determining, diagnosing, and monitoring a cardiovascular disease comprises a method for determining, diagnosing and monitoring myocardial infarction.

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