RAID-Monitor pipeline

In vitro Diagnostics. Inflammatory Bowel Disease

Ideation

Product Definition

Product Optimitzation

Product Validation

Regulatory

Testing Service

Product Launch

Product Maintenance

Definition in intestinal biopsies

45 patients with CD
25 patients with UC

31 healthy subjects

Optimization in fecal samples

54 patients with CD (34 active and 20 in remission)

79 patients with UC (30 active and 49 in remission)

Validation in target population

22 active patients with CD and UC
-American population-

319 patients with CD and UC

Ongoing Validation

CD, Crohn’s disease; UC, Ulcerative Colitic

RAID-Monitor (Risk Assessment of Intestinal Disease –Monitor) is a non-invasive, comfortable and accurate test for monitoring Crohn’s disease and Ulcerative Colitis by determining a microbial signature in stools.

Current situation: problems and needs

  • Inflammatory Bowel Disease (IBD) refers to a group of pathologies that affect the digestive tract, causing inflammatory processes. Crohn’s disease and Ulcerative Colitis are the most common ones.
  • Within the last decades, its incidence has been increasing in industrialized countries. It is estimated that affects more than 2.5 million in Europe and 1 million in the United States.
  • Due to the chronic nature of both conditions and their alternating course with periods of active inflammation and periods of remission, seamless evaluation of the disease is required to adapt the therapeutic strategy and limit its progression and complications.
  • Colonoscopy is the procedure to follow to precisely check the activity status of the disease, but due to its costs and invasiveness, non-invasive methods are preferred. However, the currently available tests are not sufficiently powerful, so they are used in combination with endoscopic techniques.

There is the need for non-invasive tests that significantly correlate with the endoscopic activity for the monitoring of IBD. 

Our Proposal

RAID-Monitor is a patented non-invasive system that offers precise monitoring of the activity status of Crohn’s disease and Ulcerative Colitis by determining a specific microbial signature in the stool sample. The diagnostic capacity of the test is significantly correlated with the endoscopic activity of these patients, offering a more effective alternative than the current available tests and allowing to reduce the number of colonoscopies performed for the monitoring of IBD.

The definition of the microbiologic signature bases on the study of 101 intestinal biopsies from patients with IBD and healthy subjects, the comparison of which has enabled the identification of a differential signature in patients with active disease. Identifying these microorganisms in the intestinal mucosa is a key point since it is more stable and resilient against external factors such as diet. The latter allows to avoid variations in the determination and to cover multiple populations with different habits. This first study has been carried out at the Hospital Universitari de Girona Dr. Josep Trueta in collaboration with the Universitat de Girona and the Institut d’Investigació Biomèdica de Girona (IdIBGi).

The next step to offer a non-invasive test for activity monitoring has been to optimize the detection in feces of this microbial signature defined in the intestinal mucosa. For this, a multicenter study has been conducted with a total of 133 fecal samples from patients with Crohn’s disease and Ulcerative Colitis, knowing their disease status. National reference hospitals participated: Hospital Universitari de Girona Dr.Josep Trueta, the Hospital Universitari de Bellvitge, the Institut d’Assistència Sanitària (IAS), and the Hospital Universitari Germans Trias i Pujol. For more information, you can consult the published results from the study here (Amoedo J, et al. 2019).

To validate that the results from the proof of concept can be extrapolated to other populations with different habits, we conducted a pilot study with 22 American patients from the Beth Israel Deaconess Medical Center in Boston (USA), in which no significant differences were observed in the diagnostic capacity of RAID-Monitor. Moreover, there is an ongoing validation in an external cohort to recruit a minimum of 319 subjects with Crohn’s Disease and Ulcerative Colitis. The study is conducted in collaboration with the Hospital Universitari de Girona Dr. Josep Trueta, the Institut d’Assistència Sanitària (IAS), the Hospital Universitari de Bellvitge, the Hospital Universitari Germans Trias I Pujol, and the Hospital General de Granollers.

RAID-Monitor will be on the market for subjects at legal age diagnosed with Crohn’s disease or Ulcerative Colitis who want to know the activity status of their disease. With our research, we want to improve the quality of life of patients by offering a fast, comfortable, and precise monitoring of their disease.