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RAID-Dx pipeline

In vitro Diagnostics. Irritable Bowel Syndrome

Ideation

Product Definition

Product Optimitzation

Product Validation

Regulatory

Testing Service

Product Launch

Product Maintenance

Definition in intestinal biopsies

10 patients with IBS
56 patients with IBD


31 healthy subjects

Optimization and validation in stool samples

80 IBS patients 58 IBD patients


74 healthy subjects

IBD, Inflammatory Bowel Disease; IBS, Irritable Bowel Syndrome

RAID-Dx (Risk Assessment of Intestinal Disease – Diagnosis) is the first non-invasive test for the accurate and reliable diagnosis of Irritable Bowel Syndrome by determining a microbial signature in stool samples.

Current situation: problems and needs

  • 9,2% of the global population suffers from Irritable Bowel Syndrome (IBS), a pathology that ranks in the top 10 most challenging diseases to diagnose according to Fleming’s List.
  • There is no positive diagnostic test for IBS. Its diagnosis consists of applying the Rome IV criteria and performing several tests to discard other pathologies that may mimic IBS.
  • Inflammatory Bowel Disease (IBD), which affects 50 million people worldwide, is one of the pathologies that can overlap with IBS and requires to perform invasive procedures for its diagnosis.
  • It is estimated that up to 45% of patients wait more than 1 year to be diagnosed, while up to 17% wait longer than 5 years.

There is the need for a non-invasive test to positively diagnose for IBS

Our Proposal

RAID-Dx is a patented non-invasive system that offers a positive diagnostic of IBS through determining the microbiological signature of the disease in the stool sample. The test allows to shorten the time to diagnosis and allows early access to an adequate treatment for the patient. Furthermore, it is also capable of differentiating IBS from IBD without the need for invasive tests.

The definition of the microbiological signature bases on the study of 111 intestinal biopsies with IBS, IBD, and healthy subjects, the comparison of which has enabled the identification of a differential signature in patients with IBS. 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 determination and to cover multiple populations with different habits. This first study has been conducted together with the Universitat de Girona, the Institut d’Investigació Biomèdica de Girona (IdIBGi) and the Hospital Universitari de Girona Dr. Josep Trueta.

The next step to offer a non-invasive diagnostic test has been to optimize and validate the detection on feces of this microbial signature defined in the intestinal mucosa. To this end, a multicenter study has been conducted with a total of 212 fecal samples from subjects with IBS and IBS diagnosed according to the current criteria and confirmed with a colonoscopy, and with healthy subjects. National and international reference hospitals have participated: Hospital Universitari de Girona Dr. Josep Trueta, the Institut d’Assitència Sanitària (IAS), the Hospital Universitari de Bellvitge, the Hospital Universitari Germans Trias i Pujol, the Centro Médico Teknon and the Beth Israel Deaconess Medical Center de Boston. For more information, you can consult the published results of the study here (Ramió-Pujol, et al. 2020).

Currently, RAID-Dx is for patients with recurrent abdominal pain and alterations in the frequency and consistency of depositions. With our research, we want to give an answer to intestinal discomfort and improve the quality of life of patients.