RAID-Prediction

In Vitro Diagnostics. Inflammatory Bowel Disease

Ideation

Product Definition

Product Optimitzation

Product Validation

Regulatory

Testing Service

Product Launch

Product Maintenance

Definition in intestinal biopsies


14 patients with CD


5 healthy subjects

Optimizaation in
fecal samples


38 patients with IBD

IBS, Irritable Bowel Syndrome; IBD, Inflammatory Bowel Disease

RAID-Prediction (Risk Assessment of Intestinal Disease – Prediction) is a non-invasive test that allows to predict treatment response in patients with Crohn’s disease or Ulcerative Colitis through the determination of a specific microbial signature in feces.

Current situation: problems and needs

  • Crohn’s disease and Ulcerative Colitis are chronic inflammatory pathologies that course with alternating periods of activity and remission. The etiology of these pathologies is still unknown, making it difficult to choose the best treatment strategy.
  • Biologic agents such as the antagonist of tumor necrosis factor alfa (anti-TNFα) have enabled a substantial advance in the treatment of these patients, improving their quality of life and decreasing surgeries and hospitalizations.
  • Nevertheless, between 10% and 30% of patients do no respond to initial treatment after the induction period, and 20% to 50% of patients require dose optimization to respond to treatment.
  • The lack of predictive markers carries unnecessary side effects and a significant economic burden on the public healthcare system.
  • Personalized medicine can be of great help in the management of IBD, knowing beforehand the most appropriate strategy for each patient.

There is the need for tools to predict treatment response and offer a personalized strategy.

Our proposal

RAID-Prediction is a non-invasive system under development that offers to increase the treatment efficacy for patients with Crohn’s disease or Ulcerative Colitis by determining a specific microbiological signature in fecal samples. The test allows to improve the patient’s quality of life and reduce substantial associated costs, through the application of personalized medicine.

The definition of the microbiological signature bases on the study of 19 intestinal biopsies from patients with Crohn’s disease confirmed with a colonoscopy and healthy subjects, whose comparison in treatment response to Adalimumab – an anti-TNFα – has allowed identifying a differential signature in responder patients. 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 conducted together with the Hospital de Girona Dr. Josep Trueta, the Universitat de Girona and the Institut d’Investigació Biomédica de Girona (IdIBGi).

The next step to offer a non-invasive diagnostic test has been to optimize the detection in feces of this microbiological signature defined in the intestinal mucosa to predict both treatment response and surgical interventions. To this end, a multicenter observational study has been carried out with a total of 38 fecal samples from subjects with Crohn’s disease and Ulcerative Colitis, treated with different anti-TNFα (Infliximab, Adalimumab, or Golimumab) to differentiate responders from non-responders to the treatment with these agents. National reference hospitals participated: Hospital Universitari de Girona Dr.Josep Trueta, the Hospital Universitari de Bellvitge and the Institut d’Assistència Sanitària (IAS). For more information, you can consult the results presented in the XXX Congres of Catalan Society of Digestology 2021 here.

Currently, there is ongoing proof-of-concept study that include evaluating specific microbial signatures from responders to other mechanisms of action and treatments. It is performed to include the range of available options and ease the decision-making in managing these patients. Once the definition of all the necessary microbial signatures has been completed and included in the algorithm, validation in an external cohort will follow. It will consist of the same steps as for the development of the other products. With all this, we expect to launch on the market in the following years.

RAID-Prediction will be on the market to predict treatment response in patients with Crohn’s disease or Ulcerative Colitis. With our research, we want to help in the process to make personalized medicine possible  to improve the quality of life of these patients.