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.

1 . A method for assessing the physiological state of a subject comprising:
 obtaining a gastrointestinal lavage fluid and/or a fecal sample from the subject; and   detecting a target molecule in the gastrointestinal lavage fluid and/or the fecal sample.   
     
     
         2 . (canceled) 
     
     
         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 - 5 . (canceled) 
     
     
         6 . The method of any one of claims  14 , wherein the target molecule
 a) comprises a polypeptide, antibody, bile acid, metabolite, or glycan;   b) comprises a biomarker, optionally, 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;   c) is associated with the presence of a cancer or predisposition to a cancer, optionally, wherein the cancer is pancreatic cancer, colorectal cancer, liver cancer, or gastric cancer; and/or   d) originated from an accessory digestive gland, optionally, wherein the accessory digestive gland is a salivary gland, pancreas, gallbladder, or liver.   
     
     
         7 - 12 . (canceled) 
     
     
         13 . The method of any one of  claim 1 , further comprising administering a lavage fluid to the subject, optionally,
 a) wherein the lavage fluid is administered orally;   b) 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; and/or   c) 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.   
     
     
         14 - 16 . (canceled) 
     
     
         17 . The method of  claim 1 , further comprising performing a colonoscopy on the subject. 
     
     
         18 . The method of  claim 1 , wherein the subject is mammalian optionally, human. 
     
     
         19 . (canceled) 
     
     
         20 . A method for identifying a biomarker comprising:
 obtaining a test gastrointestinal lavage fluid and/or a test fecal sample from a plurality of test subjects having a condition or physiological state of interest and a control gastrointestinal lavage fluid and/or a control fecal sample 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/or the test fecal sample and the control gastrointestinal lavage fluid and/or the control fecal sample, and   identifying a target molecule which is present at significantly different levels in the test gastrointestinal lavage fluid and/or the test fecal sample relative to the levels in the control gastrointestinal lavage fluid and/or the control fecal sample, thereby identifying a biomarker.   
     
     
         21 . (canceled) 
     
     
         22 . The method of  claim 20 , wherein the target molecules
 a) are selected form the group consisting of polypeptides, bile acids, antibodies, metabolites, glycans, and a combination thereof;   b) comprise a biomarker, optionally, 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;   c) is associated with presence of a cancer or predisposition to a cancer, optionally, wherein the cancer is pancreatic cancer, colorectal cancer, liver cancer, or gastric cancer; and/or   d) originated from an accessory digestive gland, optionally, wherein the accessory digestive gland is a salivary gland, pancreas, gallbladder, or liver.   
     
     
         23 . The method of  claim 20 , comprising determining the level of at least 10, 20, 30, 50 or 100 target molecules in the test gastrointestinal lavage fluid and/or test fecal sample and the control gastrointestinal lavage fluid and/or the control fecal sample. 
     
     
         24 - 32 . (canceled) 
     
     
         33 . The method of  claim 20 , further comprising administering a lavage fluid to the test subjects and the control subjects optionally,
 a) wherein the lavage fluid is administered orally;   b) 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; and/or   c) 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.   
     
     
         34 - 36 . (canceled) 
     
     
         37 . The method of  claim 20 , further comprising performing a colonoscopy on the test subjects and control subjects. 
     
     
         38 . The method of  claim 20 , wherein the test subjects and control subjects are mammalian, optionally, human. 
     
     
         39 - 54 . (canceled) 
     
     
         55 . A kit for detecting a target molecule in a gastrointestinal lavage fluid and/or a fecal sample comprising:
 a lavage fluid for oral administration to a subject;   a vessel for collecting the gastrointestinal lavage fluid and/or the fecal sample from the subject; and   an agent for detecting a target molecule which originated from outside the gastrointestinal system.   
     
     
         56 . (canceled) 
     
     
         57 . The kit of  claim 55 , further comprising a protease inhibitor. 
     
     
         58 . The kit of  claim 55 , wherein the target molecule
 a) comprises a polypeptide, antibody, bile acid, metabolite, or glycan;   b) comprises a biomarker, optionally, 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;   c) is associated with presence of a cancer or predisposition to a cancer, optionally, wherein the cancer is pancreatic cancer, colorectal cancer, liver cancer, or gastric cancer; and/or   d) originated from an accessory digestive gland, optionally, wherein the accessory digestive gland is a salivary gland, pancreas, gallbladder, or liver.   
     
     
         59 - 64 . (canceled) 
     
     
         65 . The kit of  claim 55 , wherein the lavage fluid
 a) comprises an ingredient selected from the group consisting of polyethylene glycol, magnesium sulfate, sodium sulfate, potassium sulfate, magnesium citrate, ascorbic acid, sodium picosulfate, and bisacodyh; and/or   b) is selected from the group consisting of GOLYTELY, HALFLYTELY, NULYTELY, SUPREP, FLEET'S PHOSPHO-SODA, magnesium citrate, and their generic equivalents.   
     
     
         66 . (canceled)