SYSTEMS AND METHODS FOR DETERMINING THERAPEUTIC POTENTIAL

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 at a stabilization agent, a detection agent, and a body fluid from a patient, the body fluid comprising a diagnostic marker;

a computer database capable of storing 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 marker 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 marker;

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 binding record may be used by a physician to assist in determining a therapeutic course for the patient.

3 . 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.

4 . The system of claim 1 , wherein the body fluid is selected from the group consisting of saliva, a mucous secretion, tears, sweat, semen, urine, a vaginal secretion, exhalate, blood, serum, and an anal secretion.

5 . The system 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.

6 . The system 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.

7 . The system 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.

8 . The system of claim 7 , 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 . The system of claim 1 , wherein the diagnostic marker is selected from the group consisting of Aldose reductase, Angiogenin, Annexin A1, B-cell activating factor (BAFF), B-cell lymphoma 2 (BCL2)-like 2, Beta Human chorionic gonadotropin, Ca15-3, Calcyclin, Calvasculin, Cancer Antigen CA 19-9, Cancer Antigen CA 15-3, Cathepsin D, Caveolin-1, Chromogranin A, Alpha-crystallin B chain (CRYAB), Endostatin, Eotaxin-2, Epithelial cell adhesion molecule (EpCAM), Ezrin, fatty acid binding protein 4 (FABP4), Galectin-3, γ-glutamylcysteine ligase regulatory chain (GCLR), Gelsolin, Glucose 6-phosphate (G6P), Glycoprotein 130 (gp130), Glutathione S-transferase Mu 1 (GSTM1), Hepsin, High-mobility group protein B1 (HMGB-1), Insulin-like growth factor binding protein 1 (IGFBP-1), Insulin-like growth factor binding protein 4 (IGFBP-4), Insulin-like growth factor binding protein 5 (IGFBP-5), Insulin-like growth factor binding protein 6 (IGFBP-6), LGL, latency associated peptide (LAP), macrophage stimulating protein (MSP), MHC class I polypeptide-related sequence A (MICA), Nucleoside diphosphate kinase B (NME2), Neuron-specific Enolase (NSE), Osteopontin, Osteoprotegerin, Pepsinogen, Peroxiredoxin, Phosphoserine aminotransferase (PSAT1), Prostate Specific Antigen, Receptor tyrosine-protein kinase erbB-3 (ErbB3), Serpin B3, Vascular smooth muscle cell growth factor R2 (VSGF R2/KDR), Vascular endothelial growth factor R3 (VEGF R3/Flt-4), Thyroglobulin, Tyrosine kinase with immunoglobulin-like and EGF-like domains 2 (TIE-2), Tissue plasminogen activator (tPA), Transforming growth factor beta (TGF-β1), Tumor necrosis factor receptor 1 (TNF-R1), urokinase-type Plasminogen Activator (uPA), urokinase-type Plasminogen Activator Receptor (uPAR), BrcaI, BrcaII, kallikreins, e-cadherin, Hox peptide, and Engrailed-2.

13 . A computer-implemented method of determining the therapeutic potential of a therapeutic agent, comprising the steps of:

harvesting a body fluid from a patient having a disease state;

introducing the body fluid to a detection platform comprising:

a plurality of detection sites each capable of receiving a stabilization agent, a detection agent, and a body fluid from a patient comprising a diagnostic marker;

a computer database capable of storing 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 marker 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 marker;

generate a binding record using the compared binding characteristics; and

deliver the binding record to a recipient;

contacting the body fluid with a stabilizing agent capable of completely or substantially preventing the degradation or inactivation of a diagnostic marker for the disease state;

analyzing the at least one stabilized body fluid for the at least one diagnostic marker to create a marker profile;

comparing the marker profile with a marker profile library stored in the computer database to determine a therapeutic potential of the therapeutic compound on the disease state;

generating a binding record using the compared binding characteristics; and

delivering the binding record to a recipient.

14 . The method of claim 13 , 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.

15 . The method of claim 13 , wherein the stabilizing agent comprises a plurality of stabilizing agents each present in approximately the same concentration.