Abstract: Methods of determining stabilization compounds for predictive biomarkers. According to at least one embodiment of a method of the present disclosure, the method comprises introducing a diagnostic marker and a stabilization agent to a detection platform, mixing the diagnostic marker and stabilization agent, and determining their binding characteristics. Additionally, the method may further comprise generating a report based on the binding characteristics and delivering the report to a recipient.

Abstract: Methods for determining the efficiency of a therapeutic. In at least one embodiment of a method of determining the efficacy of a therapeutic compound, the method comprises the steps of treating a subject having a disease state with an effective amount of therapeutic compound, harvesting at least one cell from the subject following a treatment with the therapeutic compound, bringing the at least one cell into contact with a stabilizing compound capable of completely or substantially preventing the degradation or inactivation of a diagnostic marker for the disease state, analyzing the at least one stabilized cell for the at least one diagnostic marker, creating a marker profile from at least one result determined from analyzing the at least one stabilized cell, and comparing the marker profile with at least one previous marker profile to determine efficacy of the therapeutic compound on the disease state.

Abstract: Systems and methods of screening biomarkers in bodily fluids. According to at least one embodiment of the system for analyzing stabilizing agents of the present disclosure, the system comprises a detection platform comprising a plurality of detection sites each capable of receiving a diagnostic marker, a stabilization agent, and a detection agent. The system, in at least one embodiment, further comprises a detection device capable of determining a binding characteristic between the detection agent and the diagnostic marker in the detection sites. Further, the system may also be able to compare the binding characteristic among a plurality of detection markers to order the level of effect of the stabilizing agents assayed on the binding characteristic between the detection agent and the diagnostic agent.

Abstract: System and methods for the detection of biomarkers. In at least one embodiment of a system for the detection of a diagnostic marker in a body fluid of the present disclosure, the system comprises a diagnostic device comprising a plurality of test wells, wherein each test well is capable of containing at least one detection agent, a detection device capable of interacting with the diagnostic device, wherein the detection device is capable of detecting an interaction between the at least one detection agent and a diagnostic marker in at least one of the plurality of test wells, and a stabilization agent contained within at least one of the plurality of test wells, the stabilization agent capable of completely or substantially preventing the degradation or inactivation of the detection agent or the diagnostic marker.

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.

Abstract: Systems and methods for the detection of biomarkers. In at least one embodiment of a microarray system of the present disclosure, the microarray system comprises a microarray product comprising at least 100 diagnostic markers/cm2, a microarray identifier, and a stabilizing agent, a control microarray product comprising a first specific binding pair member that binds to a first detectable label, and a processor for providing information regarding the identification and concentration of markers on the microarray based on the identity of the array provided by the microarray identifier.

Abstract: At least one embodiment of a stabilizing system includes a stabilizing agent present in an amount or concentration sufficient to completely or substantially prevent or reduce degradation or inactivation of a glycosylated hemoglobin (HbA1c) in a body fluid and a detection agent capable of detecting the HbA1c.

Abstract: Herein are disclosed compositions, washes, rinses, devices, systems and methods for biomarker stabilization, in part in bodily fluids, as well as methods and formulations for improving the sampling and testing of fluids for biomarkers.

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.

Abstract: Systems and methods for determining therapeutic potential. In at least one embodiment of a system of the present disclosure, the system comprises a detection platform, a computer processor and a database. The processor, in at least one embodiment of a method of the present disclosure, has and executes 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 on the platform, compare the binding characteristic, and determining the stabilizing agent with the greatest effect on the binding characteristic between the detection agent and the diagnostic marker. Further, at least one embodiment of a system for determining the therapeutic potential of a therapeutic compound of the present disclosure is able to generate a binding record using the compared binding characteristics, and deliver the binding record to a recipient.

Abstract: Device for collection and stabilization of biomarkers in liquid samples. In at least one embodiment of a fluid collection device, the device comprises a first tube operable to receive a body fluid, a second tube operable to dispense a body fluid, and a suction device operably connected to the second opening of the first tube and the first end of the second tube, wherein the suction device is operable to produce negative pressure through the first tube and is operable to exert positive pressure through the second tube. An embodiment of the devices also comprises a stabilizing agent contained within the fluid collection device, the stabilizing agent capable of completely or substantially preventing the degradation or inactivation of a diagnostic agent in a body fluid upon receipt of the body fluid into the fluid collection device.

Abstract: Systems and methods for detecting pregnancy. In at least one embodiment of a system of the present disclosure, the system comprises a stabilizing agent useful to completely or substantially prevent degradation or inactivation of a diagnostic marker for pregnancy in a body fluid comprising the diagnostic marker, and a detection agent capable of detecting the diagnostic agent.

Abstract: Systems and methods for determining food allergies. In at least one embodiment of a system of the present disclosure, the system comprises a stabilizing agent useful to completely or substantially prevent degradation or inactivation of a diagnostic marker for a food allergy in a body fluid comprising the diagnostic marker and a detection agent capable of detecting the diagnostic marker.

Abstract: Systems and methods for determining calcium levels. In at least one embodiment of a system of the present disclosure, the system comprises a stabilizing agent useful to completely or substantially prevent degradation or inactivation of a diagnostic marker for circulating calcium in a body fluid comprising the diagnostic marker, and a detection agent capable of detecting the diagnostic agent.

Abstract: Devices and systems for biomarker detection . In at least one embodiment of a diagnostic testing device of the present disclosure, the device comprises a fluid collector to collect a body fluid, and a housing, to test and retain the body fluid. The housing, in at least one embodiment, comprises a collection chamber, having an open end, to receive the fluid collector and contain a stabilization reagent, at least one membrane test strip, to indicate the presence or absence of at least one diagnostic marker, and an immunoassay-based fingerprint acquisition pad in fluid communication with the collection chamber.

Abstract: Methods for determining the efficiency of a therapeutic. In at least one embodiment of a method of determining the efficacy of a therapeutic compound, the method comprises the steps of treating a subject having a disease state with an effective amount of therapeutic compound, harvesting at least one cell from the subject following a treatment with the therapeutic compound, bringing the at least one cell into contact with a stabilizing compound capable of completely or substantially preventing the degradation or inactivation of a diagnostic marker for the disease state, analyzing the at least one stabilized cell for the at least one diagnostic marker, creating a marker profile from at least one result determined from analyzing the at least one stabilized cell, and comparing the marker profile with at least one previous marker profile to determine efficacy of the therapeutic compound on the disease state.

Abstract: Systems and methods of screening biomarkers in bodily fluids. According to at least one embodiment of the system for analyzing stabilizing agents of the present disclosure, the system comprises a detection platform comprising a plurality of detection sites each capable of receiving a diagnostic marker, a stabilization agent, and a detection agent. The system, in at least one embodiment, further comprises a detection device capable of determining a binding characteristic between the detection agent and the diagnostic marker in the detection sites. Further, the system may also be able to compare the binding characteristic among a plurality of detection markers to order the level of effect of the stabilizing agents assayed on the binding characteristic between the detection agent and the diagnostic agent.

Abstract: Systems and methods for the inhibition of galactose oxidase. According to least one embodiment of a stabilizing system of the present disclosure, the system comprises a stabilizing agent useful to completely or substantially prevent degradation or inactivation of a diagnostic marker by galactose oxidase in a body fluid including the diagnostic marker. The stabilizing system also includes a detection agent capable of detecting the diagnostic marker.

Abstract: Systems for analyzing stabilized biomarkers. In at least one embodiment of a system for the detection of a diagnostic marker of the present disclosure, the system comprises a detection platform comprising a plurality of detection wells housed in a solid matrix, wherein the detection wells contain a plurality of diagnostic markers and at least one competitor molecule, wherein the plurality of diagnostic markers and at least one control molecule are each bound to a paramagnetic particle. An embodiment of the system of the present disclosure further comprises a detection system capable of receiving the detection platform, exerting a magnetic field upon a surface of the detection platform, and determining at least one characteristic of the diagnostic marker.

Abstract: Systems and methods for the detection of biomarkers. In at least one embodiment of a microarray system of the present disclosure, the microarray system comprises a microarray product comprising at least 100 diagnostic markers/cm2, a microarray identifier, and a stabilizing agent, a control microarray product comprising a first specific binding pair member that binds to a first detectable label, and a processor for providing information regarding the identification and concentration of markers on the microarray based on the identity of the array provided by the microarray identifier.