The non-invasive solution developed by GoodGut, a company within the HIPRA group, expands the reach of colorectal cancer screening and improves diagnostic accuracy. 

In the context of the expansion of the national screening program by the Ministry of Health, a study shows how a complementary strategy supported by this tool can reduce false positives and ease the healthcare system’s burden.

As part of World Digestive Health Day and following the recent announcement by the Ministry of Health to extend the colorectal cancer screening program to individuals up to 74 years old, GoodGut—a company of the HIPRA group focused on digestive health—presents the results of a study on the implementation of its non-invasive test. The company proposes an effective solution to address sustainability, coverage, and diagnostic accuracy challenges in early detection programs for colorectal cancer (CRC).

Colorectal cancer is the most commonly diagnosed cancer in Spain, with over 44,500 new cases expected in 2025, and is the second leading cause of cancer-related death, only behind lung cancer. According to data from the Cancer Observatory of the Spanish Association Against Cancer, 15,385 people died from colorectal cancer in 2023. Five-year survival rates can reach 90% if detected in early stages, underscoring the importance of effective preventive strategies. 

In this regard, early detection of colorectal cancer is a key tool in reducing mortality, although the current screening system faces significant challenges. In this context, a triage strategy complementary to the fecal immunochemical test (FIT), currently used in screening programs, and based on gut microbiota analysis via quantitative PCR, could optimize screening accuracy without adding strain to healthcare services.

The aim of the study was to assess the clinical and budgetary impact of using GoodGut’s non-invasive test as a second-line tool after a positive result in the fecal immunochemical test (FIT). 

The study, led by Jaume Galceran, Director of the Cancer Epidemiology and Prevention Service at the Hospital Universitari Sant Joan de Reus, demonstrated an 18.4% reduction in false positives and a 95.5% sensitivity for detecting colorectal cancer, while maintaining high diagnostic accuracy. “We validated this test under real-world clinical conditions, and the results support its usefulness as a complementary tool in current early detection circuits, representing a substantial improvement in efficiency and cost-effectiveness without compromising diagnostic quality,” Galceran explains.

The data show that the test acts as an effective second-line triage method, reducing the number of unnecessary colonoscopies and improving program efficiency. It is estimated that its use could prevent more than 4,300 colonoscopies annually in Catalonia alone, with savings exceeding 1 million euros—figures that could surpass 10 million euros nationwide if the implementation is scaled. 

The multicenter study was conducted in five public hospitals in Catalonia with a sample size of over 2,000 individuals.

The Ministry of Health’s announcement to extend screening up to age 74, combined with participation rates below 45%, presents additional challenges to the healthcare system, which already faces limitations in endoscopic and human resources. The current overload is worsened by the fact that 60% of colonoscopies result in no significant findings, creating unnecessary costs and prolonged wait times. 

In this scenario, the GoodGut test offers a cost-effective solution that integrates seamlessly into the existing screening circuit, using the same sample collection method and a low-cost technique such as PCR. This improves screening accuracy without increasing care pressure, helping meet the new goals of the National Health System.

 “This study highlights our ten-year effort to develop a tool for early detection of colorectal cancer. Our goal is clear: to strengthen the screening system with a simple, accurate, and accessible technology that improves CRC early detection without compromising the sustainability of the system,” says Mariona Serra, Director of GoodGut.

HIPRA is a biotechnological pharmaceutical company focused on prevention in both animal and human health (one health), offering a wide range of highly innovative vaccines and advanced diagnostic services. With its claim “Building immunity for a healthier world,” HIPRA reaffirms its commitment to global health improvement. The company has a strong international presence, with 40 subsidiaries, 3 R&D centers, and 6 production facilities strategically located in Europe (Spain) and the Americas (Brazil). Its extensive global distribution network maintains active commercial channels with nearly 100 additional countries across all five continents. 

Research and development are the core of HIPRA’s expertise. The company dedicates over 10% of its annual revenue to R&D activities focused on applying the latest scientific advances to develop innovative, high-quality vaccines. 

HIPRA’s vaccine portfolio is based on various technological platforms. Its R&D teams work with a wide range of technologies and biological modalities. To add value to its vaccination expertise, the company also develops medical devices and traceability services for animal health.

GoodGut, a biotech company acquired by HIPRA in 2021, is focused on developing diagnostic solutions based on gut microbiota. Founded in 2014 as a spin-off from the University of Girona and the Girona Biomedical Research Institute (IDIBGI), it has three products on the market, a presence in over 79 Spanish healthcare centers, and several pipeline projects targeting digestive diseases. 

On World Digestive Health Day, this study highlights the potential of innovative strategies to optimize CRC screening without adding healthcare burden—moving toward a more sustainable, efficient, and patient-centered health system.