# US 2014/0154690 A1 · Device and method for non-invasive collection of colorectal mucocellular layer and disease detection > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2014/0154690 A1 - Document ID: US20140154690A1 - Status: Published application - Kind: A1 - Application number: 14/115,529 - Filed: 2012-05-03 - Published: 2014-06-05 - Earliest claimed: 2011-05-05 - Assignees: DiagNodus Limited - Inventors: Alexandre Loktionov; Tatiana Bandaletova; Neil Anderson - Web page: https://patentgrep.com/patent/US20140154690A1 ## CPC - G01N 1/30: Staining; Impregnating {; Fixation; Dehydration; Multistep processes for preparing samples of tissue, cell or nucleic acid material and the like for analysis} - A61B 10/0038: {Devices for taking faeces samples; Faecal examination devices (anal receptacles A61F5/451)} - G01N 33/5044: {involving specific cell types} - G01N 33/6893: {related to diseases not provided for elsewhere} - G01N 2800/065: Bowel diseases, e.g. Crohn, ulcerative colitis, IBS - G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q) - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract The present invention relates to a device and a method for collecting a sample of colorectal mucocellular layer excreted immediately following the natural act of defaecation from the surface of the anal area of a human subject, and preservation and analysis of the collected sample for detecting diagnostically informative disease biomarkers. ## Claims ### Claim 1 A non-invasive method for collecting a sample of intestinal or bowel cells or cell fragments comprising taking a swab of mucocellular layer material originating from said bowel or intestine from the surface of the anal area in the vicinity of the exterior opening of the anal canal, wherein said swab is taken following defaecation. ### Claim 2 (depends on 1) A method as claimed in claim 1 wherein the swab is taken within 5 minutes of defaecation or prior to cleaning the anal area. ### Claim 3 (depends on 1) A method as claimed in claim 1 further comprising placing said swab of mucocellular layer material in a storage or lysis medium, preferably wherein the storage medium comprises a concentrated salt solution and preferably wherein the storage medium is a liquid or gel. ### Claim 4 (canceled) ### Claim 5 (canceled) ### Claim 6 A method for diagnosing bowel disease comprising collecting a sample of intestinal or bowel cells or cell fragments using the method of any preceding claim and analysing said sample for the presence of one or more bowel disease-specific markers. ### Claim 7 (depends on 6) A method as claimed in claim 6 wherein said analysing comprises analysing the cell morphology and/or detecting the presence of and/or quantitatively or semi-quantitatively measuring one or more disease-specific molecular markers. ### Claim 8 (depends on 6) A method for screening for bowel disease using the method of claim 6. ### Claim 9 (depends on 6) A method for monitoring bowel disease using the method of claim 6. ### Claim 10 (depends on 6) A method as claimed in claim 6, wherein the bowel disease is selected from the group consisting of colorectal cancer, inflammatory bowel disease, anal cancer and advanced colorectal polyps. ### Claim 11 (canceled) ### Claim 12 (canceled) ### Claim 13 (canceled) ### Claim 14 (depends on 1) A device for use in the method of claim 1 wherein the device comprises a swab in combination with a storage or lysis medium. ### Claim 15 (depends on 14) A device as claimed in claim 14 wherein said swab comprises a porous sample collection material coupled to a lateral flow assay system, preferably wherein said porous sample collection material is flocked nylon and preferably wherein said assay system is an immunoassay or a nucleic acid hybridisation assay and preferably wherein said assay system comprises at least one test line. ### Claim 16 (canceled) ### Claim 17 (depends on 14) A device as claimed in claim 14 wherein said lysis buffer further comprises oligonucleotide primers specific for bowel disease-specific genetic markers and reagents for performing isothermal PCR, and wherein preferably said storage medium is a liquid and comprises a concentrated salt solution or said storage medium is a gel and comprises a concentrated salt solution, wherein said salt solution is not saturated, and wherein preferably the salt is ammonium sulphate. ### Claim 18 (canceled) ### Claim 19 (canceled) ### Claim 20 (canceled) ### Claim 21 (depends on 14) A device as claimed in claim 14 further comprising a gel plug. ### Claim 22 (canceled) ### Claim 23 (depends on 15) A device as claimed in claim 15 further comprising a sample holder with a cap, wherein said lateral assay system comprises a lateral assay strip between said cap and said sample collection material and wherein said cap includes a system to promote capillary action. ### Claim 24 (canceled) ### Claim 25 (canceled) ### Claim 26 (depends on 14) A kit for collecting a sample of intestinal or bowel cells comprising the device of claim 14 and a storage or lysis buffer. ### Claim 27 (depends on 26) A kit as claimed in claim 26 wherein said lysis buffer further comprises oligonucleotide primers specific for bowel disease-specific genetic markers and reagents for performing PCR. ### Claim 28 (depends on 1) A liquid or gel medium for use in the method of claim 1, the medium comprising a concentrated salt solution. ### Claim 29 (depends on 28) The liquid or gel medium as claimed in claim 28, wherein the salt is ammonium sulphate, wherein preferably said salt solution is non-saturated. ### Claim 30 (depends on 28) The gel as claimed in claim 28 further comprising a gelling agent, wherein preferably the gel comprises no more than 25% ammonium sulphate v/v and no more than 0.25% agarose w/v. ### Claim 31 (canceled) ### Claim 32 (canceled) ### Claim 33 (depends on 1) A method of assessing the efficiency of bowel disease treatment using the method described in claim 1. ### Claim 34 (depends on 33) A method as claimed in claim 33, further comprising evaluating the level of activity of bowel inflammation. ### Claim 35 (canceled)