US2013184187A1PendingUtilityA1

Systems and methods for biomarker analysis

Assignee: COMPANION DIAGNOSTICS INCPriority: Feb 10, 2010Filed: Nov 27, 2012Published: Jul 18, 2013
Est. expiryFeb 10, 2030(~3.5 yrs left)· nominal 20-yr term from priority
A61B 10/0045Y10T436/105831G01N 33/54393Y10T436/10G01N 33/50C12Q 1/40Y10T436/2525
55
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Claims

Abstract

Systems and methods of biomarker analysis. In at least one embodiment of a system for determining the therapeutic potential of a therapeutic compound the present disclosure, the system comprises a detection platform, a computer database capable of receiving a plurality of binding characteristics, a processor operably coupled to the computer database and the detection platform. In at least one embodiment, the processor has and executes a software program operational to determine a binding characteristic of the detection agent and a stabilized diagnostic agent in each of the plurality of detection sites, compare the binding characteristic among each of the plurality of detection sites, wherein the comparison of binding characteristics is capable of determining the stabilizing agent with the greatest effect on the binding characteristic between the detection agent and the diagnostic agent, generate a binding record using the compared binding characteristics, and deliver the binding record to a recipient.

Claims

exact text as granted — not AI-modified
1 . A system for determining the therapeutic potential of a therapeutic compound, the system comprising:
 a detection platform comprising a plurality of detection sites each capable of receiving a diagnostic marker, a stabilization agent, and a detection agent;   a computer database capable of receiving a plurality of binding characteristics, the plurality of binding characteristics comprising at least one binding property of a diagnostic marker to a detection agent;   a processor operably coupled to the computer database and the detection platform, the processor having and executing a software program operational to:
 determine a binding characteristic of the detection agent and a stabilized diagnostic agent in each of the plurality of detection sites; 
 compare the binding characteristic among each of the plurality of detection sites, wherein the comparison of binding characteristics is capable of determining the stabilizing agent with the greatest effect on the binding characteristic between the detection agent and the diagnostic agent; 
 generate a binding record using the compared binding characteristics; and 
 deliver the binding record to a recipient. 
   
     
     
         2 . The system of  claim 1 , wherein the stabilizing agent is selected from the group consisting of a protease inhibitor, a DNase inhibitor, and a RNase inhibitor. 
     
     
         3 . The system of  claim 1 , wherein the stabilizing agent is useful to completely or substantially prevent degradation or inactivation of a diagnostic marker selected from the group consisting of a protein, a glycoprotein, a nucleic acid, an enzyme, an enzyme inhibitor, and a metabolite. 
     
     
         4 . The system of  claim 1 , wherein the stabilizing agent is useful to completely or substantially prevent degradation or inactivation of a diagnostic marker indicative of a disease state. 
     
     
         5 . The system of  claim 4 , 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. 
     
     
         6 . The system of  claim 1 , wherein the stabilizing agent is selected from the group consisting of Fixanal® Buffer 6.0, acetic acid, aluminum hydroxide bentonite, aluminum sulfate hydrate, benzoic acid, aluminum potassium sulfate dodecahydrate, caffeine, and 3-tert-butyl-hydroxyanisole, or a combination thereof. 
     
     
         7 . The system of  claim 1 , wherein the detection platform is comprised of a material selected for the group consisting of nylon, quartz, glass, metal, silica-based materials, resins, polymers, or combinations thereof. 
     
     
         8 . The system of  claim 1 , wherein the stabilizing agent comprises a plurality of stabilizing agents each present in approximately the same concentration. 
     
     
         9 . The system of  claim 1 , wherein the stabilizing agent is capable of inhibiting degradation of the diagnostic marker to an inhibitory degree, wherein the inhibitory degree is selected from the group consisting of at least about 40%, at least about 45%, at least about 50%, at least about 55%, at least about 60%, at least about 65%, at least about 70%, at least about 75%, at least about 80%, at least about 85%, at least about 90%, at least about 95%, and at least about 99%. 
     
     
         10 . The system of  claim 1 , wherein the stabilizing agent has a concentration selected from the group consisting of about 200 parts per million (ppm) to about 2000 ppm, about 400 ppm to about 1600 ppm, about 600 ppm to about 1400 ppm, about 800 ppm to about 1200 ppm, and about 400 ppm to about 600 ppm. 
     
     
         11 . The system of  claim 1 , wherein the stabilizing agent is able to inhibit the degradation or inactivation of the diagnostic marker for an inhibitory period selected from the group consisting of at least one minute, at least about five minutes, at least about ten minutes, at least about fifteen minutes, at least about thirty minutes, at least about one hour, at least about two hours, at least about four hours, and at least about eight hours. 
     
     
         12 . A system for determining the therapeutic potential of a therapeutic compound, the system comprising:
 a detection platform comprising a plurality of detection sites each capable of receiving a diagnostic marker, a stabilization agent, and a detection agent;   a computer database capable of receiving a plurality of binding characteristics, the plurality of binding characteristics comprising at least one binding property of a diagnostic marker to a detection agent;   a processor operably coupled to the computer database and the detection platform, the processor having and executing a software program operational to:
 determine a binding characteristic of the detection agent and a stabilized diagnostic agent in each of the plurality of detection sites; 
 compare the binding characteristic among each of the plurality of detection sites, wherein the comparison of binding characteristics is capable of determining the stabilizing agent with the greatest effect on the binding characteristic between the detection agent and the diagnostic agent; 
 generate a binding record using the compared binding characteristics; and 
 deliver the binding record to a recipient; 
   wherein the stabilizing agent is selected from the group consisting of Fixanal® Buffer 6.0, acetic acid, aluminum hydroxide bentonite, aluminum sulfate hydrate, benzoic acid, aluminum potassium sulfate dodecahydrate, caffeine, and 3-tert-butyl-hydroxyanisole, or a combination thereof.

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