Non-invasive methods of detecting target molecules

Abstract

Embodiments of the present invention relate to non-invasive methods and compositions for collecting detecting, measuring, and identifying target molecules. In some embodiments, methods and compositions relate to target molecules in gastrointestinal lavage fluid or feces.

What is claimed is: 
     
         1 . A method for assessing the physiological state of a subject comprising:
 obtaining a gastrointestinal lavage fluid from the subject; and   detecting a target molecule which originated from outside the gastrointestinal system in the gastrointestinal lavage fluid.   
     
     
         2 . A method for assessing the physiological state of a subject comprising:
 obtaining a fecal sample from the subject; and   detecting a target molecule which originated from outside the gastrointestinal system in the fecal sample.   
     
     
         3 . The method of  claim 1 , wherein the gastrointestinal lavage fluid is obtained from the subject by partially purging the subject's gastrointestinal system. 
     
     
         4 . The method of  claim 1 , wherein the gastrointestinal lavage fluid comprises fecal matter. 
     
     
         5 . The method of  claim 2 , wherein the fecal sample comprises a gastrointestinal lavage fluid. 
     
     
         6 . The method of any one of  claims 1 - 5 , wherein the target molecule comprises a polypeptide, antibody, bile acid, metabolite, or glycan. 
     
     
         7 . The method of any one of  claims 1 - 6 , wherein the target molecule comprises a biomarker. 
     
     
         8 . The method of  claim 7 , wherein the biomarker is associated with a disease, a positive response to treatment, a partial response to treatment, a negative response to treatment, or no response to treatment. 
     
     
         9 . The method of any one of  claims 1 - 8 , wherein the target molecule is associated with presence of a cancer or predisposition to a cancer. 
     
     
         10 . The method of  claim 8 , wherein the cancer is pancreatic cancer, colorectal cancer, liver cancer, or gastric cancer. 
     
     
         11 . The method of any one of  claims 1 - 10 , wherein the target molecule originated from an accessory digestive gland. 
     
     
         12 . The method of  claim 11 , wherein the accessory digestive gland is salivary glands, pancreas, gallbladder, or liver. 
     
     
         13 . The method of any one of  claims 1 - 12 , further comprising administering a lavage fluid to the subject. 
     
     
         14 . The method of  claim 13 , wherein the lavage fluid is administered orally. 
     
     
         15 . The method of  claim 13 , wherein the lavage fluid comprises an ingredient selected from the group consisting of polyethylene glycol, magnesium sulfate, sodium sulfate, potassium sulfate, magnesium citrate, ascorbic acid, sodium picosulfate, and bisacodyl. 
     
     
         16 . The method of  claim 13 , wherein the lavage fluid is selected from the group consisting of GOLYTELY, HALFLYTELY, NULYTELY, SUPREP, FLEET'S PHOSPHO-SODA, magnesium citrate, and their generic equivalents. 
     
     
         17 . The method of any one of  claims 1 - 16 , further comprising performing a colonoscopy on the subject. 
     
     
         18 . The method of any one of  claims 1 - 17 , wherein the subject is mammalian. 
     
     
         19 . The method of any one of  claims 1 - 18 , wherein the subject is human. 
     
     
         20 . A method for identifying a biomarker comprising:
 obtaining a test gastrointestinal lavage fluid from a plurality of test subjects having a condition or physiological state of interest and a control gastrointestinal lavage fluid from a plurality of control subjects who do not have said condition or physiological state;   determining the level of at least 5 target molecules in the test gastrointestinal lavage fluid and the control gastrointestinal lavage fluid, and   identifying a target molecule which is present at significantly different levels in the test gastrointestinal lavage fluid relative to the levels in the control gastrointestinal lavage fluid, thereby identifying a biomarker.   
     
     
         21 . The method of  claim 20 , wherein the gastrointestinal lavage fluid comprises fecal matter. 
     
     
         22 . The method of any one of  claims 20 - 21 , wherein the target molecules are selected form the group consisting of polypeptides, bile acids, antibodies, metabolites, glycans, and a combination thereof. 
     
     
         23 . The method of any one of  claims 20 - 22 , comprising determining the level of at least 10 target molecules in the test gastrointestinal lavage fluid and the control gastrointestinal lavage fluid. 
     
     
         24 . The method of any one of  claims 20 - 22 , comprising determining the level of at least 20 target molecules in the test gastrointestinal lavage fluid and the control gastrointestinal lavage fluid. 
     
     
         25 . The method of any one of  claims 20 - 22 , comprising determining the level of at least 30 target molecules in the test gastrointestinal lavage fluid and the control gastrointestinal lavage fluid. 
     
     
         26 . The method of any one of  claims 20 - 22 , comprising determining the level of at least 50 target molecules in the test gastrointestinal lavage fluid and the control gastrointestinal lavage fluid. 
     
     
         27 . The method of any one of  claims 20 - 22 , comprising determining the level of at least 100 target molecules in the test gastrointestinal lavage fluid and the control gastrointestinal lavage fluid. 
     
     
         28 . The method of any one of  claims 20 - 27 , wherein the biomarker is associated with a disease, a positive response to treatment, a partial response to treatment, a negative response to treatment or no response to treatment. 
     
     
         29 . The method of any one of  claims 20 - 27 , wherein the biomarker is associated with the presence of a cancer or predisposition to a cancer. 
     
     
         30 . The method of  claim 28 , wherein the cancer is pancreatic cancer, liver cancer, or gastric cancer. 
     
     
         31 . The method of any one of  claims 20 - 30 , wherein at least one target molecule originated from an accessory digestive gland. 
     
     
         32 . The method of  claim 31 , wherein the accessory digestive gland is salivary glands, pancreas, gallbladder, or liver. 
     
     
         33 . The method of any one of  claims 20 - 32 , further comprising administering a lavage fluid to the test subjects and the control subjects. 
     
     
         34 . The method of  claim 33 , wherein the lavage fluid is administered orally. 
     
     
         35 . The method of  claim 33 , wherein the lavage fluid comprises an ingredient selected from the group consisting of polyethylene glycol, magnesium sulfate, sodium sulfate, potassium sulfate, magnesium citrate, ascorbic acid, sodium picosulfate, and bisacodyl. 
     
     
         36 . The method of  claim 33 , wherein the lavage fluid is selected from the group consisting of GOLYTELY, HALFLYTELY, NULYTELY, SUPREP, FLEET'S PHOSPHO-SODA, magnesium citrate, and their generic equivalents. 
     
     
         37 . The method of any one of  claims 20 - 36 , further comprising performing a colonoscopy on the test subjects and control subjects. 
     
     
         38 . The method of any one of  claims 20 - 37 , wherein the test subjects and control subjects are mammalian. 
     
     
         39 . The method of any one of  claims 20 - 38 , wherein the test subjects and control subjects are human. 
     
     
         40 . A method for identifying a biomarker comprising:
 obtaining a test fecal sample from a plurality of test subjects having a condition of interest and a control fecal sample from a plurality of control subjects and;   determining the level of at least 5 target molecules in the test fecal sample and the control fecal sample, identifying a target molecule which is present at significantly different levels in the test fecal sample relative to the levels in the control fecal sample, thereby identifying a biomarker.   
     
     
         41 . The method of  claim 40 , wherein the fecal sample comprises a gastrointestinal lavage fluid. 
     
     
         42 . The method of any one of  claims 40 - 41 , wherein the target molecules are selected from the group consisting of polypeptides, nucleic acids, bile acids, antibodies, metabolites, glycans, and a combination thereof. 
     
     
         43 . The method of any one of  claims 40 - 42 , comprising determining the level of at least 10 target molecules in the test fecal sample and the control fecal sample. 
     
     
         44 . The method of any one of  claims 40 - 42 , comprising determining the level of at least 20 target molecules in the fecal sample and the control fecal sample. 
     
     
         45 . The method of any one of  claims 40 - 42 , comprising determining the level of at least 30 target molecules in the fecal sample and the control fecal sample. 
     
     
         46 . The method of any one of  claims 40 - 42 , comprising determining the level of at least 50 target molecules in the fecal sample and the control fecal sample. 
     
     
         47 . The method of any one of  claims 40 - 42 , comprising determining the level of at least 100 target molecules in in the fecal sample and the control fecal sample. 
     
     
         48 . The method of any one of  claims 40 - 47 , wherein the biomarker is associated with a disease, a positive response to treatment, or a negative response to treatment. 
     
     
         49 . The method of any one of  claims 40 - 48 , wherein the biomarker is associated with the presence of a cancer or predisposition to a cancer. 
     
     
         50 . The method of  claim 49 , wherein the cancer is pancreatic cancer, colorectal cancer, liver cancer, or gastric cancer. 
     
     
         51 . The method of any one of  claims 40 - 50 , wherein at least one target molecule originated from an accessory digestive gland. 
     
     
         52 . The method of  claim 51 , wherein the accessory digestive gland is salivary glands, pancreas, gallbladder, or liver. 
     
     
         53 . The method of any one of  claims 40 - 52 , wherein the test subjects and control subjects are mammalian. 
     
     
         54 . The method of any one of  claims 40 - 53 , wherein the test subjects and control subjects are human. 
     
     
         55 . A kit for detecting a target molecule in a gastrointestinal lavage fluid comprising:
 a lavage fluid for oral administration to a subject;   a vessel for collecting the gastrointestinal lavage fluid from the subject; and   an agent for detecting a target molecule which originated from outside the gastrointestinal system.   
     
     
         56 . A kit for detecting a target molecule in a fecal sample comprising:
 a lavage fluid for oral administration to a subject;   a vessel for collecting the fecal sample from the subject; and   an agent for detecting a target molecule which originated from outside the gastrointestinal system.   
     
     
         57 . The kit of claim any one of  claims 55 - 56 , further comprising a protease inhibitor. 
     
     
         58 . The kit of any one of  claims 55 - 57 , wherein the target molecule comprises a polypeptide, antibody, bile acid, metabolite, or glycan. 
     
     
         59 . The kit of any one of  claims 55 - 58 , wherein the target molecule comprises a biomarker. 
     
     
         60 . The kit of  claim 59 , wherein the biomarker is associated with a disease, a positive response to treatment, or a negative response to treatment. 
     
     
         61 . The kit of any one of  claims 55 - 60 , wherein the target molecule is associated with presence of a cancer or predisposition to a cancer. 
     
     
         62 . The kit of  claim 61 , wherein the cancer is pancreatic cancer, liver cancer, colorectal cancer, or gastric cancer. 
     
     
         63 . The kit of any one of  claims 55 - 62 , wherein the target molecule originated from an accessory digestive gland. 
     
     
         64 . The kit of  claim 63 , wherein the accessory digestive gland is salivary glands, pancreas, gallbladder, or liver. 
     
     
         65 . The kit of any one of  claims 55 - 64 , wherein the lavage fluid comprises an ingredient selected from the group consisting of polyethylene glycol, magnesium sulfate, sodium sulfate, potassium sulfate, magnesium citrate, ascorbic acid, sodium picosulfate, and bisacodyl. 
     
     
         66 . The kit of any one of  claims 55 - 64 , wherein the lavage fluid is selected from the group consisting of GOLYTELY, HALFLYTELY, NULYTELY, SUPREP, FLEET'S PHOSPHO-SODA, magnesium citrate, and their generic equivalents.