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How a Sampling Device for Mucocellular Material Works

Problem: Research into gastrointestinal diseases often presents clinicians and researchers with difficulties in terms of collecting samples from patients for analysis. The very nature of the gastrointestinal tract makes it relatively inaccessible for simple, effective sampling. Current processes require the patient to collect samples of stool, have a rectal swab taken or a tissue biopsy during endoscopy. Each of these methods is not without its problems, whether for the patient, the clinician, or the researcher.

by Origin Sciences
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Stool samples are often deemed unacceptable to patients and the inconvenience of providing a sample and having to return it to the clinician or laboratory often results in patients not returning the sample. Rectal swabs can be taken by a clinician but do not provide quantitative, reproducible samples. Finally, endoscopic biopsies require the patient to follow a specific diet, take laxatives at least 24 hours before, and undergo sedation for the procedure.

All told, these problems combine to create barriers to research into gastrointestinal disease, which can result in additional processing and sample collection costs and, perhaps more significantly, inconvenience, discomfort, and undue stress for patients.

Solution: Origin Sciences has developed OriCol™, a device for the convenient and effective sampling of mucocellular material that has migrated along the entire colon to the rectum. The mucocellular sample is rich in exfoliated cells, protein, nucleic acids, and bacteria.

The sampling device incorporates a hydrophilic nitrile membrane that, upon insertion into the rectum via a standard proctoscope, is inflated with air using a syringe. The inflated membrane remains in contact with the rectal mucosa for ten seconds and is then deflated and retracted into the device prior to removal from the patient. The sample is retained within the device and can be stored, with or without buffer, prior to transportation to a laboratory for testing or fixed onto slides for further processing. A trained professional can conduct the sampling procedure in less than five minutes. No prior preparation of the bowel or special diet is required prior to sampling and data from a study involving over 700 patients demonstrates that the procedure is acceptable and well-tolerated.

The samples collected using the OriCol™ device contain a range of biomarkers to enable clinical analysis and research into gastrointestinal conditions such as colorectal cancer, inflammatory bowel disease, irritable bowel syndrome, allergies, and gut dysbiosis. The samples can provide diagnostic information relating to the presence of tumors, inflammation, bleeding, infection, and the bacterial profile of the gut. Calprotectin, haemoglobin, carcinoembryonic antigen, various antibodies, and gut microflora, are all examples of biomarkers that can be measured in samples taken using the sampling device.

With the benefits of 100 percent patient compliance, high patient acceptability, no requirement to undergo bowel preparation, dietary restrictions, or sedation; no need to handle stool samples; a reduction in the number of processing steps; and a lower risk of sample loss/spoiling in transit, the OriCol™ sampling device provides a convenient method to collect, store, and transport the samples for further analyses.

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