Functional personalized diagnosis of urinary bladder cancer patients using the ZTX(R) platform

Purpose and goal:

The purpose and goal of the project was to prepare for clinical implementation of the ZTX-Predict product for clinical treatment planning of patients with muscle invasive bladder cancer. We have succeeded in this mainly by achieving CE marking of the model, which is thus approved for routine clinical use. However, we have realized that we need a closer analysis of different market segments to understand how we can reach as many patients, as quickly as possible, and we need to do further clinical studies to demonstrate the clinical value of the ZTX-Predict product.

Expected results and effects:

We have quality assured our product and our company, as well as established processes for automation and standardization of the most central steps both before, during and after the ZTX-Predict test is run. This has been shown to generate large improvements in reproducibility, risk management and other critical quality aspects, which in turn is important for the clinical value of the product.

We have realized that ZTX-Predict will affect the market in a more complex way than we thought and we will therefore need a more accurate market analysis. We also need to do more clinical studies. Approach and implementation:

The internal processes and cooperation between the project participants have worked well. This is also reflected by the fact that the goals for technical development, patient recruitment and quality assurance have all been met with flying colors. Our approach to engage consultants etc. in market analysis has allowed an increased understanding but also an insight that this was more complex than we thought from the beginning of the project.

We should also have reacted earlier to the fact that many patients did not receive MVAC treatment, and have learned from this for our upcoming study.