From bench to bedside

Developing systems with straight forward clinical utility has been a critical goal for the research activity in DoMore!. The focal point has been to bring methods and products to a level where they can be easily implemented in the clinic and to establish the structures and collaborations that enable efficient commercialisation

One of the products developed during the DoMore! project, DoMore-v1-CRC, has successfully been brought from bench to bedside, and the groundwork for commercialisation has been broad-based.

International commercialisation often depends on patenting the products or key components of critical features. In the DoMore! project, two patent applications were filed in connection to Histotyping. While final development of market-ready products is naturally done in companies, early clinical testing requires easy-to-use applications. Thus, we have developed a software application (App), which can be run on Windows, Linux and Mac systems, making it available for use by clinicians independent of each particular clinic’s platform. The output from the App is a report showing the probability of a poor outcome, with and without the pT and pN stage.

Commercialisation may be carried out either through cooperation with an established business or through the formation of new companies. We have followed both tracks by collaborating with the Norwegian eHealth company DIPS and through the establishment of the company DoMore Diagnostics AS (DMD). The company, established in 2020, was met with substantial interest and signed on investors for NOK 15 million.

DMD was fully operable in 2021 and license agreement on four products from the project;

Histotyping CRC,
Histotyping Prostate,
Histotyping Lung and
Automatic Mitotic Figure Count.

The company has already successfully CE marked the product Histotyping CRC, and will bring the eventual commercialisation offerings to the market.

The potential benefits of histotyping are two-fold, both in identifying patients for whom the absolute benefit of adjuvant chemotherapy is low (a good prognosis assignment) as those that could benefit from prolonged or more intensive chemotherapy based on their poor prognosis assignment. This is also interesting from a health economics perspective. An evaluation conducted from a Norwegian Healthcare perspective by health economists showed that risk-stratifying stage II and III colorectal cancer patients using histotyping was cost-saving and more effective than the standard of care alone (Kenseth and Kantorova et al., 2022, under submission).To demonstrate the feasibility of histotyping in a natural clinical setting, a clinical utility study will be conducted in collaboration with DoMore! partners Vestfold Hospital Trust and Oxford University. With DoMore-v1-CRC, the establishment of DoMore Diagnostics and a health economic evaluation conducted, the framework for taking an algorithm from its development to its final product for the patient has been created. Future applications developed at ICGI will be able to follow this framework.

From bench to bedside is a project enabled by findings in the DoMore! project