UTI-lizer: PoC diagnostics for efficient UTI management in healthcare

Purpose and goal:

In order to investigate the possibility of the UTIlizer test to decentralize testing for urinary tract infection from a few central laboratories to close-to-patient clinics, the following sub-projects were set up 1) Production of demo kits 2) Engage potential customers and perform demo for at least 5

3) Engage 2 customers for further testing (clinical trials) 4 ) Update the regulatory plan according to intended users and guidelines Expected results and effects:

Market insights into varied interest from different clinic types depending on whether the patient primarily sees a doctor (primary care, urologist) or a nurse (maternity care, youth clinic) as doctors are the ones in need of test results for prescribing antibiotics.

We see great interest in the test, but few in primary care have the resources to participate in validation. A varied group of centers is the basis for planned clinical studies with updated MVP and detailed regulatory plan in place. The results have proven customer need and financial funds have been obtained for the next step.

Approach and implementation:

Demonstrations and discussions around the respective workflows of primary care and specialist care were very rewarding to create interest, understand challenges and make adjustments to the product in time before clinical trials. That information, together with an understanding of opportunities around automated production, has helped us create a reliant plan for IVDR certification.

We are very satisfied with what has been achieved, feel more confident about the market needs and the position of the UTILizer test in the market.