ColoClear is a non-invasive screening test for Colorectal Cancer (CRC), equipped with novel FIT-DNA technology to detect both precancerous and cancerous polyps in average1,2 to higher risk3 individuals. With ColoClear, patients are free to conduct the test on their own time, in the comfort of their own home, and with minimal preparation required. These elements allow ColoClear to provide an alternative screening method that is less intimidating, more affordable, and more convenient for the end user, thereby increasing acceptance and overall adherence to prevailing CRC screening guidelines.
In most parts of the world, the detection of haemoglobin in stool samples via FIT technology is the most widely recommended screening tool, and is the first level of screening offered under the current Hong Kong government-funded CRC screening programme4. However, precancerous and cancerous polyps in the colon may only bleed intermittently if at all5, which directly inhibits the ability of the FIT test to accurately detect CRC signals.
ColoClear applies stool DNA technology and FIT screening, which not only detects haemoglobin in the stool, but also multiple cancerous DNA biomarkers in intestinal cells. This multi-target DNA analysis increases the sensitivity of the product at all stages of CRC disease progression3, especially in the early stages when it is potentially most treatable.
What sets ColoClear even further apart from the competition is the sensitivity of the technology to Asian population. Large prospective clinical trials have been conducted in over 4,700 people of Asian ethnicity under NMPA review3, providing a validated test to detect CRC signals specific to the Asian market when compared to foreign competitors.
ColoClear does not diagnose colorectal cancer nor is it intended to replace colonoscopy as the gold standard for CRC detection. It is a non-invasive screening tool that aims to provide a simple and convenient screening method for average risk patients. The ease and convenience of the ColoClear test kit will be able to detect CRC in the at-risk population at an earlier and potentially more treatable stage. Compared to other screening technologies in the market today like FIT and gFOBT, ColoClear’s FIT-DNA technology has been shown in clinical studies to have the closest CRC and Advanced Adenoma sensitivity to colonoscopy standards and will identify more advanced cancers earlier in their development3. However, the slightly lower specificity implies that 8-11% more patients may have to undergo a diagnostic colonoscopy when compared to rival FIT and FOBT technologies.
ColoClear’s testing accuracy has been clinically validated in over 4700 adults aged between 40-74 years old at high risk of CRC. The 2020 Chinese CRC early prevention Expert Committee consensus statement recommends sFIT-DNA test can be used to screen average risk individuals.