ColoNode - a new dimension of lymph node status evaluation in colorectal cancer
| Reference number | |
| Coordinator | Hiloprobe AB |
| Funding from Vinnova | SEK 1 995 860 |
| Project duration | April 2020 - September 2021 |
| Status | Completed |
| Venture | Innovation projects in enterprises |
| Call | Innovation projects in small and medium-sized companies - autumn 2019 |
Important results from the project
The purpose of the project was to quickly market adapt the company´s product ColoNode for use in healthcare. ColoNode, a quantitative biomarker mRNA test for lymph node analysis, will be used to predict survival in patients operated on for colorectal cancer. The goals are to conduct a comprehensive prospective clinical study, including method development steps for RNA purification, and to CE mark ColoNode according to IVDD. Both sub-projects have been carried out very successfully and are ongoing.
Expected long term effects
Once our unique prospective clinical study, comparing ColoNode with the standard lymph node for lymph node method, is completed, we will be able to convince healthcare skeptics of ColoNode´s superiority in identifying patients with disseminated colorectal cancer. It will be vital for affected patients. Ten percent of all glands are now fully analyzed. First evaluation (3-year survival) December 2022 when the study will be completed. ColoNode is then also CE marked according to IVDD.
Approach and implementation
The design of the project was correct with two arms, a large clinical study, with direct methods comparison and sufficient number of patients as well as CE-labelling of the ColoNode kit. Implementation somewhat delayed due to the Corona pandemic, which particularly affected the productivity of laboratory staff and the latter part of the sample collection. However, the delay plays less of a role as 3-year average survival is the first sharp evaluation opportunity, which occurs in December 2022 when the project is fully implemented.