Shifting Paradigms in Colorectal Cancer Detection: The ColoSense Test Revolution

Summary:

Colorectal cancer, a major global health concern, necessitates effective screening methods. The ColoSense test, a novel multitarget stool RNA (mt-sRNA) test, emerges as a promising non-invasive alternative for colorectal cancer (CRC) detection. Adherence to recommended colonoscopies, particularly for those aged 45-49, has plateaued due to invasiveness and cost. The ColoSense test, validated in a pivotal trial with 8,920 patients, demonstrates impressive sensitivity, outperforming standard methods. In the crucial age group of 45-49, it exhibits 100% sensitivity for colorectal cancer and 45% for advanced adenomas, addressing a knowledge gap. This pioneering study takes a step towards a distributed screening platform, showing higher participation rates. The ColoSense test presents a paradigm shift in CRC screening, promising improved clinical outcomes and potentially saving lives, pending additional research and approval from the FDA.

Introduction:

Colon cancer is the second leading cause of cancer-related deaths worldwide. In 2020, more than 1.9 million new cases of colorectal cancer and more than 930,000 deaths due to colorectal cancer were estimated to have occurred worldwide.(1) Full colonoscopy is regarded as the gold standard diagnostic technique for CRC detection, and it has become a very popular method for primary CRC screening in the United States.(2) One apparent reason for this trend is that diagnostic colonoscopy is usually combined with the simultaneous removal of detected polyps and functions as both a diagnostic and preventive procedure clearly reducing mortality from CRC. Nonetheless, colonoscopy is an expensive and invasive technique that requires unpleasant bowel preparation and occasionally causes serious complications.

Fig-1: Colorectal cancer colonoscopy. [Samuel Mckenzie, Colorectal cancer pathogenesis 2018]

Despite the imperative to increase screening, adherence to recommended colonoscopies has plateaued, especially for those aged 45 to 49, owing to recent guideline modifications. However, a ray of hope emerges with the ColoSense test, a novel multitarget stool RNA (mt-sRNA) test that shows promise in transforming colorectal cancer diagnostics. (3)

The exploration of non-invasive methods for detecting colorectal cancer traces back to 1967 with Greegor's pivotal publication. In it, he noted the recurring presence of occult blood in stool samples from individuals diagnosed with CRC, sparking the inception of research into non-invasive screening techniques for this disease. That important discovery resulted in the development and prolonged use of the haemoglobin-recognising faecal occult blood test (FOBT) as the only non-invasive test for CRC detection. (4) The situation had changed considerably in 1992, when a publication by Sidransky et al (5) described K-ras gene mutation detection in stool samples obtained from CRC patients and shifted the focus of attention to molecular markers. The area of CRC biomarker research has since exponentially expanded with thousands of papers published. Here is a table showing some of them:

Table-1 Non-invasive protein (including cytokine) biomarkers used for colorectal cancer detection.[Loktionov A. Biomarkers for detecting colorectal cancer non-invasively: DNA, RNA or proteins? World J Gastrointest Oncol 2020; 12(2): 124-148 [PMID: 32104546 DOI: 10.4251/wjgo.v12.i2.124]

The ColoSense test was put to the test in a prospective pivotal trial involving 8,920 patients, aiming to identify colorectal cancer and advanced adenomas. This RNA-based technique, utilizing mt-sRNA, exhibits potential sensitivity surpassing standard imaging and endoscopy in diagnosing colorectal malignancies. According to the study findings, the mt-sRNA test demonstrated a 46% sensitivity for advanced adenomas and an impressive 94% sensitivity for colorectal cancer in individuals aged 45 and above.

Significantly, in the newly defined age range of 45-49 years, the mt-sRNA test revealed 100% sensitivity for colorectal cancer and 45% sensitivity for advanced adenomas. This breakthrough opens doors to enhanced screening strategies for a demographic that has seen a rise in colorectal cancer cases. Importantly, the mt-sRNA test's exceptional sensitivity in this age group offers a valuable tool for increasing adherence and identifying those at higher risk.

The study is pioneering in its approach, providing the first step toward clinically validating a distributed platform for colorectal cancer screening. By employing unique techniques to engage those not participating in screening, the study achieved considerably higher participation rates compared to previous noninvasive testing platforms.

For individuals aged 45-49, where a considerable knowledge gap existed regarding the effectiveness of noninvasive screening tests, the mt-sRNA test fills this void. With colorectal adenomas found in 35% of individuals in this age range, the test's sensitivity becomes a crucial factor in identifying those at risk and facilitating early intervention.

The mt-sRNA test demonstrates its potential not only in sensitivity but also in improving adenoma detection rates—an essential metric for gastroenterologists. With an overall adenoma detection rate of 40%, this figure rises to an impressive 54% among patients with a positive mt-sRNA test result, hinting at its capacity to enhance clinical outcomes by increasing the number of individuals opting for colonoscopies due to heightened sensitivity for advanced adenomas.

Conclusion:

The ColoSense test, with its groundbreaking mt-sRNA approach, emerges as a game-changer in colorectal cancer screening. Offering enhanced sensitivity, especially for the crucial age group of 45-49, it presents a promising paradigm shift in early diagnosis and prevention. As further studies progress and the FDA potentially approves its use in colorectal cancer screening, the ColoSense test holds the potential to save lives and improve health outcomes. It's not just a test; it's a beacon of hope in the fight against colorectal cancer.

Writer- Niragh Sikdar

Editor- Angad Tiwari

References:

1.World Health Organization. (n.d.). Colorectal cancer. World Health Organization. https://www.who.int/news-room/fact-sheets/detail/colorectal-cancer#:~:text=Colorectal%20cancer%20is%20the%20third,people%20aged%2050%20and%20above.

2.Hazewinkel Y, Dekker E. Colonoscopy: basic principles and novel techniques. Nat Rev Gastroenterol Hepatol. 2011;8:554-564.  [PubMed]  [DOI]  [Cited in This Article: 1]  [Cited by in Crossref: 39]  [Cited by in F6Publishing: 36]  [Article Influence: 2.8]  [Reference Citation Analysis (0)]

3.Roy, D. (2023, November 20). Colosense RNA test: Breakthrough in colorectal cancer detection. medtigo. https://medtigo.com/news/study-introduces-novel-rna-based-test-for-colorectal-cancer-screening/?t=eyJ0eXAiOiJKV1QiLCJhbGciOiJIUzI1NiJ9.eyJ1c2VySWQiOiIifQ.sYXDuQ_mmkvrfWpfkzXLZJk1pCjz2k2Sthr15VaQlDQ

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5.Sidransky D, Tokino T, Hamilton SR, Kinzler KW, Levin B, Frost P, Vogelstein B. Identification of ras oncogene mutations in the stool of patients with curable colorectal tumors. Science. 1992;256:102-105.  [PubMed]  [DOI]  [Cited in This Article: 1]  [Cited by in Crossref: 513]  [Cited by in F6Publishing: 532]  [Article Influence: 16.6]  [Reference Citation Analysis (0)]