IP Library Patent Application 12906221
Patent Application
App. No. 12/906,221

SYSTEMS AND METHODS OF ANALYZING BIOMARKER LEVELS

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Patent No.
US None
App. No.
12/906,221
Abstract

Systems and methods of analyzing biomarker levels. In at least one embodiment of a method of analyzing biomarker levels, the method comprises the steps of combining a body fluid comprising a diagnostic marker with a stabilization agent for an incubation period, introducing the stabilized body fluid into a detection platform, combining a detection agent with the stabilized body fluid, determining an interaction characteristic of the detection agent and the diagnostic marker of the stabilized body fluid using a detection device in communication with a processor, comparing the interaction characteristic with a plurality of indexed interaction records contained on a database in communication with the processor to determine an identity and concentration of the detection marker, generating a report of the identity and concentration of the detection marker in the body fluid, and delivering the report to a recipient.

Claims (26)

1 . A method of analyzing biomarker levels, the method comprising the steps of:

combining a body fluid comprising a diagnostic marker with a stabilization agent for an incubation period, the stabilization agent capable of completely or substantially preventing the degradation or inactivation of the diagnostic marker;

introducing the stabilized body fluid into a detection platform;

combining a detection agent with the stabilized body fluid;

determining an interaction characteristic of the detection agent and the diagnostic marker of the stabilized body fluid using a detection device in communication with a processor;

comparing the interaction characteristic with a plurality of indexed interaction records contained on a database in communication with the processor to determine an identity and concentration of the detection marker;

generating a report of the identity and concentration of the detection marker in the body fluid; and

delivering the report to a recipient.

2 . The method of claim 1 , wherein the detection platform is selected from the group consisting of a microarray, a multi-well plate, a high-performance liquid chromatograph, and a mass spectrometer.

3 . The method of claim 1 , wherein the diagnostic marker is selected from the group consisting of a protein, a glycoprotein, a nucleic acid, an enzyme, an enzyme inhibitor, and a metabolite.

4 . The method of claim 1 , wherein the stabilizing agent is useful to completely or substantially inactivate an enzyme selected from the group consisting of an amylase, a lysozyme, a peroxidase, a glycosidase, an esterase, a protease, and a peptidase.

5 . The method of claim 1 , wherein the stabilizing agent is selected from the group consisting of Fixanal® Buffer 6.0 (Sigma-Aldrich Co.), acetic acid, aluminum hydroxide bentonite, aluminum sulfate hydrate, aluminum potassium sulfate dodecahydrate, benzoic acid, caffeine, and 3-tert-butyl-hydroxyanisole, or a combination thereof.

6 . The method of claim 1 , wherein the stabilizing agent comprises a plurality of stabilizing agents each present in approximately the same concentration.

7 . The method of claim 1 , wherein the diagnostic marker indicative of a disease state.

8 . The method of claim 7 , wherein the disease state is selected from the group consisting of a cancer, a metabolic disease, a cardiac disease, diabetes, a bacterial infection, a viral infection, a fungal infection, and a parasitic infection.

9 . The method of claim 7 , wherein the comparing the interaction characteristic is capable of determining a diagnosis of the disease state of the subject providing the body fluid.

10 . A method of analyzing biomarker levels, the method comprising the steps of:

combining a body fluid comprising a diagnostic marker indicative of a disease state with a stabilization agent for an incubation period, the stabilization agent capable of completely or substantially preventing the degradation or inactivation of the diagnostic marker;

introducing the stabilized body fluid into a detection platform;

combining a detection agent with the stabilized body fluid;

determining an interaction characteristic of the detection agent and the diagnostic marker of the stabilized body fluid using a detection device in communication with a processor;

comparing the interaction characteristic with a plurality of indexed interaction records contained on a database in communication with the processor to determine an identity and concentration of the detection marker;

generating a report of the identity and concentration of the detection marker in the body fluid; and

delivering the report to a recipient;

wherein the stabilizing agent is selected from the group consisting of Fixanal® Buffer 6.0 (Sigma-Aldrich Co.), acetic acid, aluminum hydroxide bentonite, aluminum sulfate hydrate, aluminum potassium sulfate dodecahydrate, benzoic acid, caffeine, and 3-tert-butyl-hydroxyanisole, or a combination thereof.

The method of claim 10 , wherein the comparing the interaction characteristic is capable of determining a diagnosis of the disease state of the subject providing the body fluid.

Assignments (2)
SECURITY INTEREST Recorded Apr 3, 2014
From: COMPANION DIAGNOSTICS, INC.
To: BMO HARRIS BANK N.A.
Reel/Frame 032597/0400 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 27, 2013
From: SELINFREUND, RICHARD H.; VIG, RAKESH; GILL, RICHARD P.
To: COMPANION DIAGNOSTICS INC.
Reel/Frame 029890/0026 →