E!2584: Clinical validation of a new diagnostic test for Drug SEnsitivity Evaluation in ColoRectal Cancer (DSEE-CRC)

The innovation is a new in vitro diagnostic test platform for selecting the most effective drug treatment for individual cancer patients. The test is based on drug screening of the patient’s own living cancer cells and performs a unique analysis of the cells’ response to a range of clinically relevant drugs and drug combinations. The results are fed into a nomination algorithm that generates a personalized diagnostic report. The treating physician uses the report to tailor subsequent drug regimens. This approach has the potential to dramatically increase the number of patients benefiting from anti-cancer drug therapies and reduce the costs from unnecessary side effects. Early studies show that the technology has a predictive accuracy above 80% for metastatic colorectal cancer, but the clinical feasibility and utility is uncertain. Several promising retrospective and prospective clinical trials have been performed, but sample sizes are small and randomized trials are lacking. In this project, Oncosyne and partners will generate initial data on clinical performance by conducting an exploratory, interventional, open-label, randomized control trial. Here, the in vitro diagnostic test will be used to guide drug treatment for patients with metastatic colorectal cancer refractory to standard-of-care therapy. The study will employ end-to-end standardized and scalable assay conditions to facilitate transfer into clinical routine if successful.

The innovation is a new in vitro diagnostic (IVD) platform for selecting the most effective drug treatment for individual cancer patients. The IVD is based on drug screening of the patient’s own living cancer cells and performs a unique analysis of the cells’ response to a range of clinically relevant drugs and drug combinations. The results are fed into a nomination algorithm that generates a personalized diagnostic report. The treating physician uses the report to tailor subsequent drug regimens. This approach has the potential to dramatically increase the number of patients benefiting from anti-cancer drug therapies and reduce the costs from unnecessary side effects. Early studies show that the technology has a predictive accuracy above 80% for metastatic colorectal cancer, but the clinical feasibility and utility is uncertain. Several promising retrospective and prospective clinical trials have been performed, but sample sizes are small and randomized trials are lacking. Hence, there is a clear need for further industrial research activities to show that this diagnostic approach is feasible and has clinical utility. In this project Oncosyne and partners will address feasibility and generate initial data on clinical performance by conducting an exploratory interventional, open-label, randomized control trial. Here, the IVD test will be used to guide drug treatment for patients with metastatic colorectal cancer refractory to 1st and 2nd line standard-of-care therapy. The study will employ end-to-end standardized and scalable assay conditions to facilitate transfer into clinical routine if successful.