VIB and DNAlytics are proud to announce their partnership to develop a data–driven, high–performance and non–invasive Colorectal Cancer screening test, the ColonoKit. Colorectal cancer is the third most common form of cancer globally and the second most common cause of cancer deaths. The chance of a cure is high if the cancer is detected early enough, but early detection is not a given. Based on a research program from VIB, KU Leuven and UZ Leuven, with the support of the Fournier Majoie Foundation, DNAlytics will develop the ColonoKit which should make it possible to detect colorectal cancer in an early stage using a simple blood test.

Prof. Hans Prenen, UZ Leuven: “From my daily practice I experience the need for a test that offers greater certainty and that can detect bowel cancer at an early stage and at the same time reaches the whole population. It fills me with joy that via our research we can actually contribute to such a test.”

A novel test by implementing scientific insights in a performant diagnostic platform DNAlytics will now develop ColonoKit making use of an online software platform derived from their currently marketed RheumaKit, for arthritis patients’ management. The platform complements the transcriptomic inputs of the test with a Machine Learning approach, offering the perspective of a continuously–improving test, based on a routine feedback loop.

Prof. Massimiliano Mazzone, VIB–KU Leuven said: “I have been working on the role of the immune system in cancer for more than 10 years now. A puzzling field with a lot of potential towards clinical application. It is great that our works now forms the basis of a novel diagnostic kit with clear advantages for the patients.”

This program was also supported by the Fournier Majoie foundation. Bernard Majoie PhD, President and Founder: “Back in 2010 the pioneering proposal of prof Massimiliano Mazzone about identifying cancer bio–markers out of monocytes was enthusiastically received by FFM’s jury. 7 years later a “signature” has been confirmed and we are proud about our contribution to this achievement answering a real and urgent medical need. We consider our task is not at its end, there are still regulatory and late development issues to endeavor before the kit can be at practitioner’s hands, the FFM will be happy to help the young company DNAlytics to win this part of the course.”

From the moment that colorectal cancer cells are present in the body, the peripheral blood monocytes respond to the substances secreted by the cancer cells. The researchers from VIB, KU Leuven and UZ Leuven identified 23 genes with a specific role in this process that could be used as set of bio–markers. These bio–markers are incorporated in the test. In total, about 550 samples have been prospectively collected for this project so far. In a first step, the gene signature has been identified on about 100 individuals (healthy volunteers and CRC patients), followed by a second round including 200 samples (among which half from healthy volunteers and half from CRC patients). In a third step, about 150 samples have been used for the validation of the same approach in a technological setting fitting routine requirements.

Sensitivity and specificity of the test were both above 90% in a validation cohort. Therefore, introducing ColonoKit in the screening campaign as a confirmatory step before colonoscopy could result in a decrease of up to 50% in the number of useless or non–urgent colonoscopies. ColonoKit is likely to be more expensive than stool tests, but will still represent only a fraction of the cost of a colonoscopy. Extra clinical validation is ongoing.