Imagine trying a key in a lock without knowing if it actually fits; that is how current cancer immunotherapies work for many patients. This technology acts like a master key tester, checking if a patient's proteins will actually react to the drug before treatment starts. By knowing who will respond, doctors can stop guessing and only treat those who will truly benefit.
Current immunotherapy for solid tumors has a low response rate of 10-20%, leading to wasted resources and missed opportunities for patients. There is an urgent need for a reliable way to predict which patients will actually respond to treatment.
A multiplexed protein-function based biomarker assay (IOO) and a collaborative user cloud designed for CE Mark and ISO 13485/27001 compliance.
If you are an IVD manufacturer dealing with low adoption of precision oncology tools — this project developed a multiplexed protein-function biomarker assay that could triple the efficacy of current immune-oncology treatments. It provides a validated way to stratify patients for 90% of current therapies.
If you are a biotech company dealing with high clinical trial failure rates due to poor patient selection — this project developed a predictive assay that identifies responders. This could potentially double survival rates for lethal tumors like lung cancer.
If you are a hospital network dealing with the high cost of ineffective immunotherapy for the 80-90% of patients who don't respond — this project developed a bio-imaging based assay to optimize patient stratification. This ensures expensive therapies are only given to those predicted to respond.
Based on available project data, specific pricing and cost structures are not disclosed.
The project is industrializing a TRL6 assay by developing a collaborative user cloud and implementing a Quality Management System (QSM) reaching 80% completion.
The assay is based on proprietary bio-imaging technology owned by Fastbase Solutions; however, specific licensing terms are not provided in the dataset.
The company is pursuing CE marking, an IVD manufacture license from AEMPS, and evaluating a 510k application with the FDA for the USA market.
The project runs from August 2024 to December 2031, with current efforts focused on retrospective studies and regulatory certification.
The project is led by a single Spanish SME, Fastbase Solutions Sociedad Limitada. With a 100% industry ratio and no university or research partners, the project is lean and focused entirely on the commercialization and regulatory path (CE mark and FDA 510k) rather than basic research.
Contact Fastbase Solutions Sociedad Limitada in Spain
Contact us to explore licensing opportunities for this TRL6 predictive assay.
