IP Library Granted Patent US 8,029,982
Granted Patent B2
US 8,029,982 · App. 12/775,382 · Granted Oct 4, 2011

Biomarkers for sepsis

Assignee: Alere San Diego, Inc.
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Quick Facts
Patent No.
US 8,029,982
App. No.
12/775,382
Granted
Oct 4, 2011
Kind
B2
Abstract

Biomarkers for sepsis and resulting mortality can be detected by assaying blood samples. Changes in the concentration of the biomarkers can be used to indicate sepsis, risk of sepsis, progression of sepsis, remission from sepsis, and risk of mortality. Changes can be evaluated relative to data sets, natural or synthetic or semisynthetic control samples, or patient samples collected at different time points. Some biomarkers' concentrations are elevated during disease and some are depressed. These are termed informative biomarkers. Some biomarkers are diagnostic in combination with others. Individual biomarkers may be weighted when used in combinations. Biomarkers can be assessed in individual, isolated or assays, in parallel assays, or in single-pot assays.

Claims (12)

1. A method of diagnosing sepsis in a human subject suspected of having sepsis, comprising:

determining a concentration of at least one analyte in a fluid test sample from said human subject;

comparing the concentration of each said analyte(s) to a corresponding reference concentration selected to indicate the presence or absence of sepsis, wherein said reference concentration is determined using one or more control samples obtained from one or more human subjects not suffering from sepsis, provided that at least one of said analyte(s) is myeloid progenitor inhibitory factor-1 (“MPIF-1”), wherein an elevation in concentration of said analyte(s) in the test sample of at least about two fold relative to the reference concentration is indicative of the presence of sepsis in the human; and

diagnosing sepsis in the human subject using the result(s) of said comparing step.

2. The method of claim 1 wherein said samples comprise blood.

3. The method of claim 1 wherein said samples comprise serum.

4. The method of claim 1 wherein said samples comprise plasma.

5. The method of claim 1 wherein further provided that at least one analyte is interleukin 1 receptor antagonist (“IL-1 Ra”).

6. The method of claim 1 wherein further provided that at least one analyte is monocyte chemotactic protein-1 (“MCP-1”).

7. The method of claim 1 wherein further provided that at least one analyte is tumor necrosis factor receptor-1 (“TNF-R1”).

8. The method of claim 1 wherein sepsis is diagnosed if the concentrations of at least two of said analytes in said test sample are elevated at least about two fold relative to the corresponding reference concentrations.

9. The method of claim 1 wherein an elevation in concentration of MPIF-1 in the test sample of at least about four fold relative to the reference concentration is indicative of the presence of sepsis in said human.

Assignments (10)
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 →
CORRECTIVE ASSIGNMENT TO CORRECT THE ASSIGNEE PREVIOUSLY RECORDED ON REEL 025373 FRAME 0307. ASSIGNOR (S) HEREBY CONFIRMS THE CORRECT ASSIGNEE IS MOLECULAR STAGING INC AND NOT ALERE INTERNATIONAL. Recorded Mar 21, 2011
From: KINGSMORE, STEPHEN F.; LEJNINE, SERGUEI J.; DRISCOLL, MARK; TCHERNEV, VELIZAR T.
To: MOLECULAR STAGING, INC.
Reel/Frame 026008/0626 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 2, 2011
From: MOLECULAR STAGING INC.
To: LILLY RESEARCH LABORATORIES, A DIVISION OF ELI LILLY & COMPANY
Reel/Frame 025886/0373 →
CHANGE OF NAME Recorded Mar 2, 2011
From: BIOSITE INCORPORATED
To: ALERE SAN DIEGO, INC.
Reel/Frame 025887/0075 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 2, 2011
From: ELI LILLY AND COMPANY
To: BIOSITE INCORPORATED
Reel/Frame 025886/0788 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 18, 2010
From: KINGSMORE, STEPHEN F.; LEJNINE, SERGUEI J.; DRISCOLL, MARK; TCHERNEV, VELIZAR
To: ALERE INTERNATIONAL
Reel/Frame 025373/0307 →
Continuity (2)
Continuation 10759216 · Jan 20, 2004
Related Publication 20100304981A1 · Dec 2, 2010