IP Library › Granted Patent US 7,713,705
Granted Patent B2
US 7,713,705 · App. 10/330,696 · Granted May 11, 2010

Markers for differential diagnosis and methods of use thereof

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Quick Facts
Patent No.
US 7,713,705
App. No.
10/330,696
Granted
May 11, 2010
Kind
B2
Abstract

The present invention provides methods for the identification and use of diagnostic markers for differential diagnosis of diseases. In a various aspects, the invention relates to methods and compositions able to determine the presence or absence of one, and preferably a plurality, of diseases that exhibit one or more similar or identical symptoms. Such methods and compositions can be used to provide assays and assay devices for use in determining the disease underlying one or more non-specific symptoms exhibited in a clinical setting.

Claims (18)

1. A method, comprising:

contacting a test sample obtained from a subject with a test surface of a diagnostic device, wherein the test surface is within a capillary space of the diagnostic device and comprises a plurality of discrete addressable locations, each of the discrete addressable locations comprising discrete immobilized particles comprising antibodies bound thereto for binding a marker, the diagnostic device comprising immobilized particles at discrete addressable locations for detecting each of B-type natriuretic peptide or a marker related to B-type natriuretic peptide, D-dimer, and at least one cardiac troponin form selected from the group consisting of free cardiac troponin I, free cardiac troponin T, cardiac troponin I in a complex comprising one or both of troponin T and troponin C, cardiac troponin T in a complex comprising one or both of troponin I and troponin C, total cardiac troponin I, and total cardiac troponin T;

detecting the amount of each of B-type natriuretic peptide or a marker related to B-type natriuretic peptide, D-dimer, and at least one cardiac troponin form selected from the group consisting of free cardiac troponin I, free cardiac troponin T, cardiac troponin I in a complex comprising one or both of troponin T and troponin C, cardiac troponin T in a complex comprising one or both of troponin I and troponin C, total cardiac troponin I, and total cardiac troponin T; and

determining the presence or absence of each of myocardial infarction, pulmonary embolism, and congestive heart failure in said subject based on the results obtained from said analyzing step;

wherein detecting an amount of at least one cardiac troponin form above a threshold level rules in myocardial infarction;

further wherein when a detected amount of at least one cardiac troponin form is below a threshold level, and the detected amount of D-dimer is above a threshold level, pulmonary embolism and congestive heart failure are distinguished by comparing the amount of D-dimer to the amount of BNP or a marker related thereto detected in said test sample.

2. The method according to claim 1 , wherein said subject suffers from dyspnea.

3. The method according to claim 1 , wherein said analyzing step further comprises performing one or more assays that detect one or more of pulmonary surfactant protein D and atrial natriuretic peptide or a marker related to atrial natriuretic peptide.

4. The method according to claim 1 , wherein said marker related to B-type natriuretic peptide is NT-proBNP or proBNP.

5. The method according to claim 1 , wherein said analyzing step further comprises performing one or more assays that detect one or more additional subject-derived markers related to myocardial injury.

6. The method according to claim 1 , wherein said sample is blood, serum, or plasma.

7. The method according to claim 1 , wherein said plurality of markers are detected in a sandwich immunoassay.

8. The method according to claim 1 , wherein said test surface is a porous membrane.

9. The method according to claim 1 , wherein said test surface is a nonporous surface.

10. The method according to claim 3 , wherein said analyzing step further comprises performing an assay that detects pulmonary surfactant protein D.

11. The method according to claim 3 , wherein said analyzing step further comprises performing an assay that detects atrial natriuretic peptide or a marker related to atrial natriuretic peptide.

12. The method according to claim 1 , wherein said analyzing step further comprises performing one or more assays that detect one or more subject-derived markers related to coagulation and hemostasis.

13. The method of claim 1 , wherein said method further comprises providing a treatment regimen to treat said subject based on determining the presence or absence of each or myocardial infarction, congestive heart failure, and pulmonary embolism.

Assignments (10)
SECURITY AGREEMENT Recorded Aug 22, 2025
From: CRIMSON INTERNATIONAL ASSETS LLC; MICRO TYPING SYSTEMS, INC.; ORTHO-CLINICAL DIAGNOSTICS, INC.; QUIDEL CARDIOVASCULAR INC.
To: BANK OF AMERICA, N.A., AS ADMINISTRATIVE AGENT
Reel/Frame 072526/0643 →
RELEASE (REEL 060220 / FRAME 0711) Recorded Aug 22, 2025
From: BANK OF AMERICA, N.A.
To: QUIDEL CORPORATION; BIOHELIX CORPORATION; DIAGNOSTIC HYBRIDS, INC.; QUIDEL CARDIOVASCULAR INC.; ORTHO-CLINICAL DIAGNOSTICS, INC.; CRIMSON U.S. ASSETS LLC; CRIMSON INTERNATIONAL ASSETS LLC; MICRO TYPING SYSTEMS, INC.
Reel/Frame 072577/0536 →
RELEASE OF SECURITY INTEREST Recorded May 31, 2022
From: BANK OF AMERICA, N.A.
To: QUIDEL CARDIOVASCULAR INC.
Reel/Frame 060052/0786 →
SECURITY AGREEMENT Recorded May 31, 2022
From: QUIDEL CORPORATION; BIOHELIX CORPORATION; DIAGNOSTIC HYBRIDS, INC.; QUIDEL CARDIOVASCULAR INC.; ORTHO-CLINICAL DIAGNOSTICS, INC.; CRIMSON U.S. ASSETS LLC; CRIMSON INTERNATIONAL ASSETS LLC; MICRO TYPING SYSTEMS, INC.
To: BANK OF AMERICA, N.A.
Reel/Frame 060220/0711 →
TRIAGE ASSIGNMENT, ASSUMPTION AND BILL OF SALE Recorded Oct 24, 2017
From: ALERE SAN DIEGO, INC.
To: QUIDEL CARDIOVASCULAR INC.
Reel/Frame 044281/0152 →
SECURITY INTEREST Recorded Oct 6, 2017
From: QUIDEL CARDIOVASCULAR INC.
To: BANK OF AMERICA, N.A., AS ADMINISTRATIVE AGENT
Reel/Frame 043803/0359 →
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 →