An automated fecal-testing device for home-based IBD monitoring

4C Diagnostics develops an automated fecal-testing device and platform for home-based IBD monitoring. The 4C device enables, for the first time, a fully automated stool sampling, processing and analysis, using the commercially available diagnostic assays and kits. The 4C device enables better adherence for frequent tests that produce immediate results and real-time actionable data for better tailoring of treatment and better disease management by both patient and physician, leading to increased clinical remission rates, reduced healthcare cost-burden, and improved disease outcomes, as well as patient empowerment and well-being. The 4C platform is applicable for a variety of user scenarios and presents a novel modality for all-purpose stool collection.

Why fecal tests?

• Inflammatory Bowel Diseases monitoring (Calprotectin levels in stool)
• Foodborne diseases and pathogen diagnosis
• Colorectal cancer screening
• Microbiome research and treatment

For IBD patients:
• Individualized monitoring of disease activity
• Prediction of outbursts (actionable data for therapeutic adjustments)
• Tailored treatment
• Monitoring response to medication
• Patient empowerment and adherence with treatment

The 4C solution:

The 4C platform is an all-In-One Sampling, processing, analyzing and Reporting platform, that includes disposable and reusable units, suitable for home use by IBD patients, or for occasional users at home and at Point of Care. Using the 4C platform to collect and analyze a stool sample requires minimal actions by the user and minimal contact with the sample – eliminating all human factors related variability and improving user compliance and adherence to performing the test. The 4C platform has modularity and adaptability to any of the existing lateral flow assays and kits in the market, and is adaptable to existing IBD disease management apps.

User benefits:
• No need to deploy collection paper on toilet -
  o Can be done anywhere
  o User can keep the regular flow of actions when going to the toilet
• Minimal actions are required – easy for frequent use -
  o Wipe
  o Put wiper in collection unit
  o Insert to 4C MiniLab
• Quantified sampling, processing, analysis, image capture – all automated -
  o No need for training by a healthcare professional
  o No human errors derived inaccuracies
  o Reproducibility
  o No need for cellular camera and calibration (cellphone is not part of the test procedure)
  o Results can automatically be sent to physician
• All process in done in a closed environment –
  o No contact and odor
  o Hygienic and clean