Non-invasive test for colorectal cancer detection
Colorectal cancer (CRC) has a 48 % mortality rate, and is the third most common cancer worldwide, with millions of new cases every year. These dismal statistics can be improved through recommended screening programmes which can detect premalignant lesions in the colon and rectum, called advanced adenomas (AAs). These sometimes appear as long as 10 years before the tumour. Most of these cancers and deaths could be prevented and cured when diagnosed early. CRC has a 5-year survival rate of 90 % if diagnosed in Stage I, but only 14 % if diagnosed in Stage IV. Despite this, compliance is low, with only 10 % of the eligible population undertaking the necessary screening through colonoscopy or a faecal test. As consumer resistance to the colonoscopy procedure is the main reason for this low take-up, there is a clear unmet medical need for early, accurate and easy cancer detection.
Specific blood biomarkers for CRC
The EU-funded ColoFast initiative sought to resolve this medical issue by developing a non-invasive test for the prompt diagnosis of CRC. “Our innovative blood-based test combines cutting-edge molecular biomarkers for the early detection of CRC and AAs in the average risk population of people between 50 to 75 years old,” explains Carmen Monsalve, Clinical Affairs Director of Amadix, a company working in liquid biopsy technologies. To validate the CRC-associated biomarkers, the team performed a European prospective study in 3 300 healthy average-risk asymptomatic individuals between 50 and 75 years old in Germany and Poland. The molecular signature used in the test was a collection of microRNAs that can differentiate healthy individuals from those with AAs or CRC. The test was further validated in other case-control studies with over 1 000 patient samples. ColoFast measures the levels of specific biomarkers in the plasma of blood samples, and then, Amadix executes a diagnostic algorithm. A positive result indicates the presence of AAs or CRC and should be followed by diagnostic colonoscopy.
ColoFast convenience and excellence set to change CRC screening
Results indicate that ColoFast has superior sensitivity in detecting premalignant lesions. It can be easily implemented in laboratory hospitals, requiring no extra investment or extensive staff training. And importantly, it comes at a competitive price. “The non-invasive nature of ColoFast, combined with its high diagnostic specificity, sensitivity and speed, will change the paradigm of CRC screening,” emphasises Monsalve. This will ensure better screening compliance and improve the survival chances of patients. Project partners envision that up to 2 million people across Europe could benefit from the test in 2024. Initially, ColoFast will be offered from centralised reference labs. Ongoing talks with hospitals, distribution and health insurance companies are expected to further widen the availability of the test after obtaining the CE mark in July 2021. The ColoFast test is set to change CRC screening guidelines. Furthermore, Amadix has identified – with the second leading health insurance company in Europe – a set of risk factors associated with the development of CRC using big data and artificial intelligence tools. The incorporation of these risk factors through newly generated prediction models will improve the performance of the ColoFast test, achieving even greater accuracy.
Keywords
ColoFast, colorectal cancer (CRC), molecular test, blood test, microRNA, advanced adenomas (AA), risk