RAID-CRC pipeline

In Vitro Diagnostics. Colorrectal cancer

Ideation

Product Definition

Product Optimitzation

Product Validation

Regulatory

Testing Service

Product Launch

Product Maintenance

Definition in intestinal biopsies

60 patients with CRC

20 healthy subjects

Optimization in fecal samples

450 subjects with CRC compatible symptomatology

189 subjects from screening population (≥ 50 years, FIT +, asymptomatic)

Validation
in target population

327 subjects from screening population (≥ 50 years, FIT +, asymptomatic)

2.800 subjects from screening population (≥ 50 years, FIT +/-, asymptomatic)

CRC, Colorectal Cancer; FIT, Fecal Immunochemical Test.

RAID-CRC (Risk Assessment of Intestinal Disease – Colorectal Cancer Diagnosis) is a non-invasive, fast, and easy-to-use, and economical test to pre-diagnose colorectal cancer and determine the risk in previous stages using biomarkers present in stool samples

Current situation: problems and needs

  • Colorectal cancer (CRC) is the third most incident cancer and the second in mortality worldwide, according to the World Health Organization.
  • European guidelines advise CRC prevention based on population risk detection (people aged from 50 to 75 years)
  • Current screening programs use the fecal occult blood test (Fecal Immunochemical Test, FIT). However, blood is not a specific marker for CRC, implying a high false-positive rate and a high number of unnecessary colonoscopies.

There is the need for non-invasive tools capable of providing early and accurate detection of CRC.

Our proposal

RAID-CRC is a non-invasive patented system that complements the national screening for Colorectal Cancer (CRC) based on the Immunological fecal occult blood test (FIT) by determining a microbiological signature of CRC in the fecal samples. The test presents greater precision for the detection of the precancerous lesion, offering tranquility, comfort, and reduction of unnecessary colonoscopies.

The definition of the microbiologic signature bases on the study of 80 intestinal biopsies with CRC and subjects with normal colonoscopy, the comparison of which has made it possible to identify a differential signature in patients with the disease. Identifying these bacteria in the intestinal mucosa is a key point, since it is more stable and resilient against external factors such as diet. The latter allows us to avoid variations in determination and to cover different populations with different habits. This first clinical study was carried out at the Hospital Universitari de Girona Dr. Josep Trueta.

The next step to offer a non-invasive diagnostic test has been to optimize the detection in feces of the bacterial signature defined in the intestinal mucosa. To this end, a multicenter study was carried out with 450 fecal samples from subjects with CRC compatible symptomatology who underwent a colonoscopy and 189 subjects from a screening population with a positive result in the fecal occult blood test. Five leading hospitals in oncology participated: Hospital Universitari de Girona Dr. Josep Trueta, el Hospital Universitari de Bellvitge, el Institut Català de Oncologia, el Institut de Salut (IAS), el Consorci Hospitalari de Vic y el Complexo Hospitalario de Ourense. For more information, you can consult the published results of the study here (Malagón, et al. 2019 Malagón, et al. 2020).

The results of the proof of concept have been validated in external cohorts with a total of 327 FIT + subjects from the screening population, in collaboration with Hospital Universitari de Girona Dr. Josep Trueta, Hospital Universitari de Bellvitge, and the Institut de Salut (IAS). In addition, to complete the validation of RAID-CRC, a clinical study has been conducted with 2.800 patients from the German screening program in collaboration with the German Cancer Research Center (DKFZ), a leading European cancer research center.

Currently, RAID-CRC is offered to subjects at legal age with CRC compatible symptomatology or with interest in undergoing a routine control for the early detection of colorectal cancer. With our research we want make available to everyone a precise and comfortable tool for the prevention of this disease.