Development of PoC rapid diagnostic for infectious respiratory disease

Purpose and goal

Readily develops a sensitive rapid test for respiratory disease. In minutes, seven of the most common viruses and bacteria can be detected, with a simple yes or no answer. This test will be available at the emergency department and in elderly care to be able to quickly determine what treatment a patient needs or if isolation is needed to prevent the spread of infection. The test is to be certified by CE-IVD as a diagnostic test and we are expected to be on the market in 2027. We are working together with regulatory expertise for the regulatory work so that it goes as quickly as possible.

Expected effects and result

What we want to get out of this project is a clear strategy plan, documents that should contain Development plan where regulatory eligibility requirements are listed - what types of analytical studies need to be done on the product. Compilation of technical documentation. Clinical testing plan what type of clinical testing needs to be performed and on what type of sample. Process Development/Production Development Plan what type of studies need to be done in production. We want to know exactly how we develop and produce the best product.

Planned approach and implementation

We want to produce quality documents, a system for quality control, which we within the company must work according to. The competence transfer from the regulatory expert to the company takes place when we develop these plans together, learn how to implement quality systems through training with the regulatory expert.