By Pedro Romero, Chief Medical Officer, Novigenix.

Two recent original research papers published in the March edition of the New England Journal of Medicine highlight the momentum in screening for colorectal carcinoma (CRC) and high-risk colorectal adenomas. These developments mark a significant milestone in the fight against CRC and signal additional momentum for Novigenix’ approach to early detection of colorectal cancer. Our pioneering approach combines liquid biopsy with AI and RNA analysis of the immune system’s response to cancer, promising transformative improvement in screening methodologies.

The potential of liquid biopsy in revolutionizing screening methods

Colorectal cancer is the third most common cancer worldwide and poses a significant global health concern, affecting for instance 153,000 individuals in 2023 in the United States alone and ranking as the second leading cause of cancer-related death.  Moreover, projections for 2040 estimate a 63% increase in CRC incidence rate, highlighting an urgent need for prevention and novel screening strategies. In addition, developing effective early cancer detection assays using liquid biopsies, particularly utilizing circulating tumor DNA (ctDNA), is challenging due to technological and biological limitations, making it difficult to achieve high sensitivity (70%+) at high specificity (90%+).

Despite screening recommendations for adults aged 45 to 75, adherence rates remain below target levels, with screening rates at just under 60% in 2021.

Recent studies, such as the ECLIPSE study, and the PREEMPT CRC study offer promise in improving colorectal cancer screening rates. 

  • ECLIPSE study: funded by Guardant Health, this study evaluated a blood-based cell-free DNA (cfDNA) test for colorectal cancer (CRC) detection. Over 10,000 participants were initially enrolled, with a focus on 7,861 eligible individuals. The cfDNA test demonstrated a sensitivity of 83% for CRC detection and 90% specificity for advanced neoplasia. Notably, it showed particular effectiveness in identifying early-stage CRCs, with a sensitivity of 87.5% for stage I to III cancers. However, sensitivity dropped to 13.2% for advanced precancerous lesions. The test also exhibited a false-positive rate of 10.4%. So, although the study demonstrated the feasibility of using plasma cfDNA to screen for CRC, the relatively low sensitivity for detecting advanced precancerous lesions is a limitation. 
  • PREEMPT CRC study: additionally, insights from the PREEMPT CRC study by Freenome further underscore the potential of blood-based screening. Initiated in 2020, the study involved over 200 sites and enrolled 48,995 participants aged between 45 and 85, who were asymptomatic and considered at average risk. The study’s top-line results highlighted a 79.2% sensitivity in detecting colorectal cancer, with varying degrees of sensitivity for different cancer stages. For instance, it showed a 57.1% sensitivity for Stage I, 100% for Stage II, 82.4% for Stage III, and 100% for Stage IV cancers.

As the above studies delve into blood-based approaches for early cancer detection, they highlight the transformative potential of liquid biopsy in revolutionizing screening methods. 

Overcoming Challenges

However, challenges persist, especially in the detection of precancerous lesions, which are critical to CRC screening as they serve as precursors to cancer development. All liquid biopsy assays validated so far have encountered difficulties in identifying these lesions. With projections for 2040 estimating a 60% increase in CRC incidence rate, there is an urgent need for prevention and novel screening strategies. Early detection of colon cancer could prevent more than 90% of CRC-related deaths, underscoring the significance of leveraging multiplexed technologies to enhance performance and save lives by identifying individuals at the precancerous stage.

While early cancer detection is crucial for optimal therapeutic response, the reality is that more than one-third of the screening-eligible population is not up to date with screening. As outlined in a recent NYT article, the momentum for liquid biopsy is recognized beyond the scientific community.  “A Blood Test Shows Promise for Early Colon Cancer Detection. Many patients are reluctant to undergo colonoscopies or conduct at-home fecal tests. Doctors see potential in another screening method,” states the article. 

Convincing people to undergo screening poses challenges due to factors such as the time required, scheduling difficulties, and fear associated with invasive tests like colonoscopy. Despite these obstacles, adherence to screening is crucial, and ease of blood sample collection in routine medical practice bears great potential to increased adherence.

Against this backdrop, Novigenix addresses these challenges head-on, with particular emphasis on robust and simple blood sampling as well as enhancing sensitivity in detecting precancerous lesions.

Leveraging Novigenix Technology for Enhanced Detection

With a decade-long track record, Novigenix has successfully launched Colox in Switzerland. This non-invasive blood test, powered by AI and RNA analysis, detects early-stage colon cancer, marking a significant departure from invasive colonoscopy procedures. By aggregating data from diverse colon cancer patients, Novigenix identifies immune system biomarkers crucial for early-stage detection, enhancing treatment outcomes. Committed to continuous improvement, Novigenix is actively enhancing Colox by integrating the latest technological advancements for mass international adoption.

At the core of our innovation lies the LITOSeek™ platform, which overcomes challenges in blood analysis by providing deeper insights into immune response and disease progression. LITOSeek™ not only enhances the detection of precancerous lesions but also predicts responses to treatment, guiding personalised therapies. This technology holds promise for early cancer detection and monitoring, with ongoing collaborations exploring its application across various cancer types and immunotherapies.

Driving Collaboration for Better Patient Outcomes

Novigenix is excited to see such progress on so many fronts and is pleased to see also the collaboration taking place. We are proud to collaborate with the European Union IMMUcan consortium to develop RNA biomarkers for checkpoint inhibitor response in cancer patients. This partnership aims to advance cancer research by profiling tumors and their microenvironments, contributing to the fight against cancer globally.

As many new studies explore blood-based approaches for early cancer detection, Novigenix stands at the forefront of innovation in colorectal cancer screening, particularly the sensitivity in detecting precancerous lesions. With our cutting-edge technologies and collaborative efforts, we are dedicated to improving patient outcomes and contributing to the field of cancer screening and novel therapy development. The recent advancements provide a promising backdrop for our continued efforts to eradicate cancer.