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GoodGut, a biotechnology spin-off of the University of Girona (UdG) and IDIBGI, has been awarded a €1.1-millions grant through the Ministry of the Economy and Competitiveness Retos de Investigación 2016 program to validate and develop a non-invasive screening system for colorectal cancer. It also received €175,000 from the CDTI Neotec 2015 grants, which it will invest in consolidating the company's research lines and in its laboratory located in the University of Girona Science and Technology Park.

The new test being developed by GoodGut is based on the RAID-CRC method (Risk Assessment Intestinal Disease-colorectal cancer), which uses bacterial markers in feces to detect pre-cancerous lesions before clinical signs of colorectal cancer. This detection system comes from a study led by Xavier Aldeguer (co-founder of the spin-off and head of the digestion unit at Trueta Hospital) and Jesús Garcia-Gil (co-founder of the spin-off and professor of Microbiology at the University of Girona) that showed a very high correlation between certain bacteria in the feces and colorectal cancer.

The company is now completing the clinical validation phase, which has been conducted with more than 500 patients at various centers in Catalonia (Hospital de Bellvitge, Catalan Institute of OncologyConsorci Hospitalari de Vic, Hospital Dr. Trueta de Girona and Institut d’Assistència Sanitària), and hopes to present results in December or January. "This phase has allowed us to see how the bacterial profile behaves in all populations at risk of colorectal cancer," explains Dr. Mariona Serra, co-founder and CEO of GoodGut.

"We have to wait for the results to know which risk populations the markers work best for, but our goal is to focus on mid-level risk groups, which are individuals over 50," explains Serra. After this phase, GoodGut aims to do a third clinical study focusing exclusively on this group, using part of the funding received through the Retos program.

Currently, the only method for diagnosing colorectal cancer is colonoscopy, an invasive technique that is time-consuming and expensive. In order to limit the number of colonoscopies done, the fecal occult blood test is used to screen the mid-level risk group (individuals over 50) beforehand. However, the lack of specificity of this test means that 30% of colonoscopies are done unnecessarily. So, the test developed by GoodGut, which could be on the market as early as 2019, would be used to reduce the number of false positives of the fecal occult blood test and improve prevention in colorectal cancer.

At the same time, the company is also developing a non-invasive system to detect intestinal inflammatory diseases, in patients with Crohn’s and ulcerative colitis. Also in the clinical phase, the system is being tested on patients at Hospital de Bellvitge and Hospital Dr. Trueta and will soon begin a trial at Hospital Germans Trias i Pujol. The device the company is developing allows for differential diagnosis, with monitoring and prediction of therapeutic and surgical treatments. "Based on the results of this study, we will design a trial with a larger scope focusing on higher-risk populations," explains Mariona Serra.


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