If you are a diagnostics company dealing with low adoption of post-surgical monitoring — this project developed a ctDNA assay that identifies micro-metastatic residual disease. This allows for a shift from generic monitoring to precision diagnostics for stage II and III colon cancer.
Precision Blood Testing to Personalize Colon Cancer Treatment and Reduce Over-Chemotherapy
Imagine if doctors could tell if a few cancer cells are still hiding in your body after surgery just by taking a blood sample. Right now, most patients get the same harsh chemotherapy regardless of whether they actually need it. This project uses a 'liquid biopsy' to find these hidden cells and tailor the treatment to each person's specific genetic makeup.
What needed solving
Current colon cancer treatment uses a 'one-fits-all' chemotherapy approach, leading to significant over-treatment or under-treatment because doctors cannot detect micro-metastatic residual disease using standard imaging.
What was built
A clinical trial protocol and a ctDNA assay to detect residual disease, paired with a genomic characterization tool to personalize therapy.
Who needs this
Who can put this to work
If you are a pharma company dealing with inefficient patient stratification in clinical trials — this project developed a genomic landscape characterization method. This ensures targeted therapies are given only to ctDNA-positive patients, maximizing the odds of cure.
If you are a clinic owner dealing with high costs of unnecessary chemotherapy — this project developed a 'Wait&See' strategy for ctDNA-negative patients. This reduces waste and improves patient quality of life by avoiding over-treatment.
Quick answers
What is the cost or price of the ctDNA assay?
Based on available project data, specific pricing is not mentioned, but the project includes a health-economics evaluation to measure cost-effectiveness.
Can this be scaled to an industrial level?
The project is currently being tested across 26 clinical sites in 5 countries, suggesting a scalable clinical network model.
What are the IP and licensing options?
Based on available project data, specific IP or licensing terms are not provided; however, the consortium includes 2 industry partners and 2 SMEs.
What regulatory hurdles have been cleared?
The study protocol has been approved by regulatory and ethical authorities via the Clinical Trials Information System (CTIS) in Italy, Spain, and Germany.
What is the timeline for results?
The project runs from 2023-07-01 to 2028-06-30, with patient recruitment already active as of December 2024.
Who built it
The consortium is well-balanced for translation, consisting of 9 partners across 5 countries. With an industry ratio of 22% (including 2 SMEs and 2 larger industry players) alongside 3 universities and 2 research institutes, the project has the necessary mix of academic rigor and commercial viability to move from trial to market.
Contact IFOM-Istituto Fondazione di Oncologia Molecolare ETS in Italy
Talk to the team behind this work.
Contact us to explore licensing opportunities for the ctDNA assay and genomic profiling protocols.