Colorectal cancer (CRC) remains one of the most common and preventable forms of cancer worldwide. According to the American Cancer Society, colorectal cancer accounts for approximately 10% of all cancer cases globally, with over 1.9 million new cases diagnosed annually.[1] Early detection plays an important role in improving survival rates, as CRC is highly treatable in its early stages. In many cases, symptoms do not appear until the disease has progressed, creating a pressing need for reliable and non-invasive screening tools like the Fecal Occult Blood Test (FOBT).
The Fecal Occult Blood Test detects occult (hidden) blood in the stool, which is a potential indicator of colorectal cancer. Occult blood results from minor bleeding in the gastrointestinal tract caused by abnormal growths, inflammation, or vascular disorders. These small amounts of blood are typically not visible to the naked eye, emphasizing the importance of chemical or immunochemical tests for detection. Normal gastrointestinal physiology involves the breakdown of food and absorption of nutrients, a process that does not typically result in blood entering the stool. Pathological conditions, however, disrupt the intestinal lining, leading to microscopic bleeding.
The FOBT has been a cornerstone of CRC screening programs for decades. Traditionally, there are two main types of FOBTs:
- Guaiac-based FOBT (gFOBT): This test detects peroxidase activity in hemoglobin using a chemical reaction with guaiac. While cost-effective and widely available, gFOBT has significant limitations, including a high false-positive rate due to dietary and medication interferences. [2]
- Fecal Immunochemical Test (FIT): FIT utilizes antibodies to detect human hemoglobin specifically, offering greater sensitivity and specificity compared to gFOBT. FIT has become increasingly favored due to its ease of use, accuracy, and lack of dietary restrictions. [3]
Both tests are recommended for individuals aged 45 and older, with annual testing as part of routine CRC screening. However, adherence to FOBT screening programs remains low in many regions due to accessibility issues, test complexity, and socioeconomic barriers.
The socioeconomic cost of CRC screening through the FOBT varies based on healthcare infrastructure and test type. The guaiac-based FOBT, being less expensive, has traditionally been used in large-scale programs, costing approximately $3–$5 per test. However, due to its lower sensitivity and accuracy, follow-up diagnostic procedures such as colonoscopy can be required for false-positive cases, increasing overall healthcare expenditure. In contrast, the Fecal Immunochemical Test (FIT) is more expensive (ranging from $20–$40 per test) but reduces the need for follow-ups due to its improved accuracy. [4]
The economic burden of CRC treatment in later stages underscores the importance of cost-effective screening. Late-stage treatment costs can start at $60,000 to upwards of $300,000 per patient, compared to an estimated $1,500–$5,000 for early detection and removal of polyps. Investing in screening programs like FOBT has significant long-term economic benefits, particularly in low-economic settings. [5]
The Standard Colorectal Hemoglobin Immunochemical Test (SCHIT) sets out to use FOBT technology while also addressing its limitations by utilizing biomarkers to improve the specificity of these tests such that the SCHIT is a diagnostic tool for colorectal cancer screening. These innovations could significantly reduce false-positive rates and promise to lower the economic burden on healthcare systems by minimizing unnecessary diagnostic procedures.