With about 1.8 million new patients and over 861,000 deaths every year, colorectal cancer (CRC) is one of the most commonly diagnosed and deadliest cancers globally. Regular, systematic and early screening of (primarily) asymptomatic at-risk populations is critical to identify the disease early and treat appropriately. Current screening methods, including the faecal immunological test (FIT), are able to detect the disease, but are false-positive in two-thirds of patients as determined by colonoscopy. This burdens the healthcare system unnecessarily and shows that the market needs a better solution, e.g. an improved, non-invasive method that can discriminate CRC true positive patients in the FIT-positive test population.
It is estimated that the global cancer screening test market will grow from 900 million in 2019 to 1.3 billion USD in 2025 (CAGR 5.3%). Faecal tests dominate with 85% of this market, but the market share of novel molecular tests is growing nearly twice as fast as the overall market. Healthcare systems are overburdened due to poor performance of current faecal tests and very high costs of molecular tests on the market. Therefore, a simple and much cheaper solution based on the CELTIC test panel is expected to have a major impact by dramatically improving the CRC diagnostic workflow efficiency.
Researchers at the University of Bologna have developed a liquid biopsy test that can detect colorectal cancer at early to late disease stages. The test is based on the gene expression profile of four genes (the CELTIC panel). In the first validation studies the test has demonstrated a clinical sensitivity of 79% and a specificity of 94% comparing healthy vs. early stage disease and 75% and 87%, respectively, when comparing healthy vs. advanced stage disease. The CELTIC test panel will be initially developed as an add-on/follow-up to the CRC screening approach with FIT- tests to be followed by improved methods that will challenge the position of the FIT test as the current primary screening test.
Currently, as a next step in product development further validation of the CELTIC panel is ongoing and large-scale multi-center European clinical trials are being planned.
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