CEO comment

"Overall, our pioneering product platform for digital immunoassay has enormous potential”

We have worked intensively during the first quarter of the year with our unique digital immunoassay. The platform could become the first digital, ultra-sensitive, portable POC platform for testing high-sensitive troponin and eventually for performing many other clinical tests in large indication areas.

During this quarter, we selected Integrated Technologies Limited (ITL) as a partner to develop the commercial instrument. The collaboration was entered into to ensure that the commercial instrument is state-of-the-art and compliant with all regulatory standards required for an in-vitro diagnostic product (IVD). ITL brings deep manufacturing knowledge and high expertise in optics and mechanical engineering. We are delighted with our choice of partner and have already started good cooperation.

This next step in product development is based on the fully functional research-level prototypes we have developed in-house. We currently have six prototypes that will be used to develop the reagent cartridge and to define the requirements for developing the commercial platform.

As for the internal pilot production of cartridges, it will start in May in our renovated and adapted premises.

A promising sign of the high level we maintain within the Company is the grant from SBRI Healthcare. The quarter saw the completion of phase two of the approximately £1 million grant received last year. The allocation was conditional on implementing certain milestones that have now been met or exceeded, including developing fully functional prototypes. The grant has accelerated the development of the digital immunoassay and is a great recognition.

During the quarter, we were also pleased that TTP reached a positive milestone in the development project in distributed testing for PLD MicroFlex; two laboratory-based diagnostic tests were transferred to the platform, indicating that the platform will be able to be used for commercially available laboratory tests. TTP is now working on identifying a suitable commercial partner to continue the development necessary to bring the technology to market. We follow their work with great interest.

After the end of the quarter, we submitted two priority patent applications covering different multiplex aspects to the Intellectual Property Office in the UK. Multiplex means detecting several different biomarkers at the same time on a single sample. The first application covers various aspects of multiplexing. By using our unique single molecule counting technology, multiplexing can be carried out in a single drop of blood on a sensor without needing to split the sample into separate areas. The second application uses a similar approach to allow the measurement of the same biomarker at both very low and very high concentrations simultaneously. The benefit of the unique technology is that the sample size remains extremely small, and that the sensor is easy to manufacture, yet also offering the ability to detect very low concentrations of biomarkers with high specificity. 

Our subsidiary Psyros has already filed three patent applications for its unique digital immunoassay technology. The first application has passed the PCT phase and is now being pursued in different territories worldwide. The second and third applications are in the PCT phase. The two new patent applications will enter the PCT phase in 2024.

Overall, our pioneering product platform for digital immunoassay has enormous potential and, as a first step, we are very well positioned to bring a high-sensitive troponin assay to the market. The system is also very easily operated and has low production costs making it incredibly costeffective, just what the market demands. I look forward to reporting back to you.

Lund in May 2023

Ulf Bladin, CEO Prolight Diagnostics AB (publ.)