Digital platform for multiparametric diagnostic tests - step 2
Purpose and goal
OncoAlgorithms business idea is to accelerate the transition of multiparametric diagnostic tests (MPDTs) from research to live clinical use. In this project we have three aims: Evaluate technical requirements for adding novel MPDTs to the system. Evaluate and develop control samples. Quality assurance according to ISO 13485.
Expected results and effects
The foundation of product scalability will be established through review of how novel MPDTs are most easily added to the portal. Intricate control sampels made to provide unique added value for customers will be developed. Finally, the quality management system within which all business is conducted will be conceived and implemented. With all that, the company will be ready to take a strong position in the MPDT market.
Planned approach and implementation
We will evaluate how three selected and different MPDTs could be added to the system with minimum impact on regulatory and legal structures. As for control samples we will evaluate the combination of multiparametric design and statistical monitoring within the framework of the STHLM3 test. The quality management system will be built with implementation in focus.