IP Library › Granted Patent US 7,361,473
Granted Patent B2
US 7,361,473 · App. 10/139,086 · Granted Apr 22, 2008

Diagnostic markers of acute coronary syndrome and methods of use thereof

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Quick Facts
Patent No.
US 7,361,473
App. No.
10/139,086
Granted
Apr 22, 2008
Kind
B2
Abstract

The present invention relates to methods for the diagnosis and evaluation of acute coronary syndromes. In particular, patient test samples are analyzed for the presence and amount of members of a panel of markers comprising one or more specific markers for myocardial injury and one or more non-specific markers for myocardial injury. A variety of markers are disclosed for assembling a panel of markers for such diagnosis and evaluation. In various aspects, the invention provides methods for the early detection and differentiation of stable angina, unstable angina, and myocardial infarction. Invention methods provide rapid, sensitive and specific assays that can greatly increase the number of patients that can receive beneficial treatment and therapy, reduce the costs associated with incorrect diagnosis, and provide important information about the prognosis of the patient.

Claims (13)

1. A method of diagnosing an acute coronary syndrome in a subject, said method comprising

performing a first immunoassay that detects a first marker selected from the group consisting of BNP and NT-proBNP on a test sample obtained from said subject;

performing a second immunoassay that detects a second marker selected from the group consisting of free cardiac troponin I, complexed cardiac troponin I, free and complexed cardiac troponin I, free cardiac troponin T, complexed cardiac troponin T, free and complexed cardiac troponin T on a test sample obtained from said subject; and

correlating the results obtained from said first and second immunoassays to the presence or absence of an acute coronary syndrome in said subject by comparing a result from said first immunoassay to a first threshold level and comparing a result from said second immunoassay to a second threshold level, wherein when said first immunoassay result exceeds said first threshold level and said second immunoassay result does not exceed said second threshold level, the presence of myocardial ischemia in the absence of myocardial infarction is diagnosed in said subject, and when said second immunoassay result exceeds said second threshold level myocardial infarction is diagnosed in said subject.

2. A method according to claim 1 , wherein said method further comprises performing one or more additional immunoassays that detect one or more additional markers selected from the group consisting of creatine kinase-MB, heart fatty acid binding protein, D-dimer, C-reactive protein, and matrix metalloproteinase-9 on a test sample obtained from said subject, and wherein said correlating step further comprises correlating the results obtained from additional immunoassay(s), together with the results obtained from said first and second immunoassays, to the presence or absence of an acute coronary syndrome in said subject.

3. A method according to claim 1 , wherein said test sample is selected from the group consisting of blood, serum, and plasma.

4. A method according to claim 1 , wherein said test sample is fractionated prior to being analyzed.

5. A method according to claim 1 , wherein the results are correlated to the presence or absence of stable angina.

6. A method according to claim 1 , wherein the results are correlated to the presence or absence of unstable angina.

7. A method according to claim 1 , wherein the results are correlated to the presence or absence of myocardial infarction.

8. A method according to claim 1 , wherein the immunoassays are performed on a single test sample.

9. A method according to claim 1 , wherein said method comprises correlating said immunoassay results together with one or more clinical variables selected from the group consisting of a history of congestive heart failure, renal function, electrocardiographic changes, a history of coronary artery disease, body mass index, and diabetes to the presence or absence of an acute coronary syndrome in said subject.

10. A method according to claim 1 , wherein said subject is experiencing constricting chest pain when said test sample is obtained.

Assignments (7)
RELEASE OF SECURITY INTEREST IN INTELLECTUAL PROPERTY RECORDED AT REEL 036994, FRAME 0192 AND REEL 037115, FRAME 0498 Recorded Oct 5, 2017
From: HEALTHCARE FINANCIAL SOLUTIONS, LLC, AS COLLATERAL AGENT
To: ALERE CONNECT, LLC; ALERE SAN DIEGO, INC. (FKA BIOSITE INC. OR FKA CHOLESTECH CORP. OR FKA HEMOSENSE INC. OR FKA INVERNESS MEDICAL-BIOSTAR INC. OR FKA ISCHEMIA TECHNOLOGIES, INC. OR FKA TWISTDX, INC.); ALERE SCARBOROUGH, INC. (FKA MATRITECH, INC. FKA ADVANTAGE DIAGNOSTICS CORP. OR FKA BINAX, INC. OR FKA MILANO ACQUISITION CORP.); INNOVACON, INC. (FKA APPLIED BIOTECH, INC. OR FKA AMEDITECH INC.); IONIAN TECHNOLOGIES, LLC (FKA IONIAN TECHNOLOGIES, INC.); QUALITY ASSURED SERVICES INC. (FKA ZYCARE INC.); STANDING STONE, LLC; ESCREEN, INC.
Reel/Frame 044213/0258 →
ASSIGNMENT OF IP SECURITY AGREEMENT, PREVIOUSLY RECORDED AT REEL 036994, FRAME 0192 Recorded Nov 16, 2015
From: GENERAL ELECTRIC CAPITAL CORPORATION, AS RETIRING ADMINISTRATIVE AGENT
To: HEALTHCARE FINANCIAL SOLUTIONS, LLC, AS SUCCESSOR ADMINISTRATIVE AGENT
Reel/Frame 037115/0498 →
INTELLECTUAL PROPERTY SECURITY AGREEMENT Recorded Oct 29, 2015
From: ALERE CONNECT, LLC; ALERE SAN DIEGO, INC. (FKA BIOSITE INC. OR FKA CHOLESTECH CORP. OR FKA HEMOSENSE INC. OR FKA INVERNESS MEDICAL-BIOSTAR INC. OR FKA ISCHEMIA TECHNOLOGIES, INC. OR FKA TWISTDX, INC.); ALERE SCARBOROUGH, INC. (FKA MATRITECH, INC. FKA ADVANTAGE DIAGNOSTICS CORP. OR FKA BINAX, INC. OR FKA MILANO ACQUISITION CORP.); INNOVACON, INC. (FKA APPLIED BIOTECH, INC. OR FKA AMEDITECH INC.); IONIAN TECHNOLOGIES, LLC (FKA IONIAN TECHNOLOGIES, INC.); QUALITY ASSURED SERVICES INC. (FKA ZYCARE INC.); STANDING STONE, LLC; ESCREEN, INC.
To: GENERAL ELECTRIC CAPITAL CORPORATION, AS COLLATERAL AGENT
Reel/Frame 036994/0192 →
NOTICE OF RELEASE OF SECURITY INTEREST IN PATENTS RECORDED AT REEL 026557 FRAME 0287 Recorded Jun 23, 2015
From: GENERAL ELECTRIC CAPITAL CORPORATION, AS ADMINISTRATIVE AGENT AND COLLATERAL AGENT
To: ADVANTAGE DIAGNOSTICS CORPORATION; ALERE MEDICAL, INC.; ALERE SAN DIEGO, INC.; ALERE SCARBOROUGH, INC.; AMEDITECH INC.; APPLIED BIOTECH, INC.; BINAX, INC.; BIOSITE INCORPORATED; CHOLESTECH CORPORATION; GENECARE MEDICAL GENETICS CENTER, INC.; HEMOSENSE, INC.; INSTANT TECHNOLOGIES, INC.; INVERNESS MEDICAL - BIOSTAR INC.; ISCHEMIA TECHNOLOGIES, INC.; MATRITECH, INC.; MATRIA HEALTHCARE, INC.; ZYCARE, INC.
Reel/Frame 036011/0581 →
SECURITY AGREEMENT Recorded Jul 7, 2011
From: ADVANTAGE DIAGNOSTICS CORPORATION; ALERE MEDICAL INCORPORATED; ALERE SAN DIEGO, INC.; ALERE SCARBOROUGH, INC.; AMEDITECH INC.; APPLIED BIOTECH, INC.; BINAX, INC.; BIOSITE INCORPORATED; CHOLESTECH CORPORATION; GENECARE MEDICAL GENETICS CENTER, INC.; HEMOSENSE, INC.; INSTANT TECHNOLOGIES, INC.; INVERNESS MEDICAL - BIOSTAR INC.; ISCHEMIA TECHNOLOGIES, INC.; MATRITECH, INC.; ZYCARE INC.; MARTIA HEALTHCARE, INC.
To: GENERAL ELECTRIC CAPITAL CORPORATION
Reel/Frame 026557/0287 →
SECURITY AGREEMENT Recorded Jul 6, 2007
From: BIOSITE INCORPORATED
To: GENERAL ELECTRIC CAPITAL CORPORATION, AS AGENT
Reel/Frame 019523/0276 →
SECURITY AGREEMENT Recorded Jul 5, 2007
From: BIOSITE INCORPORATED
To: GENERAL ELECTRIC CAPITAL CORPORATION, AS AGENT
Reel/Frame 019519/0929 →