Methods and devices for determining a disease state

Abstract

The present invention, in some embodiments thereof, relates to methods and devices for determining a disease state in a patient. In some embodiments, human serum albumin may be analyzed for associated molecules, wherein the associated molecules are related to a disease such as cancer. Certain aspects of the invention are generally directed to devices and methods for determining a disease state as a function of the three-dimensional structure of a blood protein, human serum albumin (HSA) or its complex with other ligands, e.g., due to binding to disease-specific ligands. HSA interacts with biomolecules associated with a disease presence, and liganded HSA may differentially partition between aqueous phases of a predetermined partitioning system, wherein the partitioning behavior differs between HSA from healthy individuals and HSA from people harboring the predetermined disease, such as breast cancer.

What is claimed is: 
     
         1 - 13 . (canceled) 
     
     
         14 . A device for the detection of breast cancer, including:
 a unit for collecting blood from a patient and separating serum or plasma from said blood;   at least one aqueous two-phase partitioning system in fluid communication with the unit for collecting blood;   a unit for partitioning a portion of said serum or plasma in said two phase partitioning system in fluid communication with the partitioning system;   an assay for determining the presence of human serum albumin in aqueous phases of said two phase partitioning system;   a computing element adapted to determine a coefficient K, wherein K represents the distribution of human serum albumin in the aqueous portions of said two-phase partitioning system; and,   a determination element adapted to compare said coefficient K with known values of K for blood samples of healthy individuals and individuals with breast cancer.   
     
     
         15 - 47 . (canceled) 
     
     
         48 . The device according to  claim 14 , wherein said assay is an HSA-specific immuno-based assay. 
     
     
         49 . The device according to  claim 14 , wherein the device comprises a microfluidic channel in fluidic communication with the partitioning system. 
     
     
         50 . The device according to  claim 14 , wherein said two-phase partitioning system is adapted to differentially partition albumin when breast cancer is present or absent in said patient. 
     
     
         51 . The device according to  claim 14 , wherein said computing element and said determination element are a single element. 
     
     
         52 . The device according to  claim 51 , wherein said computing device is one of the following: mainframe computer, laptop computer, tablet computer, mobile computing device, and tabletop computer. 
     
     
         53 . The device according to  claim 14 , wherein said unit for partitioning comprises a centrifuge component. 
     
     
         54 . The device according to  claim 14 , wherein the patient is human. 
     
     
         55 . A device for the detection of cancer, including:
 a unit for collecting blood from a patient and separating serum or plasma from said blood;   at least one aqueous two-phase partitioning system in fluid communication with the unit for collecting blood;   a unit for partitioning a portion of said serum or plasma in said two phase partitioning system in fluid communication with the partitioning system;   an assay for determining the presence of human serum albumin in aqueous phases of said two phase partitioning system;   a computing element adapted to determine a coefficient K, wherein K represents the distribution of human serum albumin in the aqueous portions of said two-phase partitioning system; and,   a determination element adapted to compare said coefficient K with known values of K for blood samples of healthy individuals and individuals with cancer.   
     
     
         56 . The device according to  claim 55 , wherein said assay is an HSA-specific immuno-based assay. 
     
     
         57 . The device according to  claim 55 , wherein the device comprises a microfluidic channel in fluidic communication with the partitioning system. 
     
     
         58 . The device according to  claim 55 , wherein said two-phase partitioning system is adapted to differentially partition albumin when cancer is present or absent in said patient. 
     
     
         59 . The device according to  claim 55 , wherein said computing element and said determination element are a single element. 
     
     
         60 . The device according to  claim 59 , wherein said computing device is one of the following: mainframe computer, laptop computer, tablet computer, mobile computing device, and tabletop computer. 
     
     
         61 . The device according to  claim 55 , wherein said unit for partitioning comprises a centrifuge component. 
     
     
         62 . The device according to  claim 55 , wherein the patient is human. 
     
     
         63 . The device according to  claim 55 , wherein the cancer is prostrate cancer. 
     
     
         64 . The device according to  claim 55 , wherein the cancer is selected from the group consisting of throat cancer, stomach cancer, pancreatic cancer, brain cancer, lung cancer, cervical cancer, testicular cancer, ovarian cancer, oral cancer, throat cancer, esophagus cancer, and intestinal cancer.