CEO comment

“The next important milestone is proof-of-performance for troponin, which we hope to demonstrate before the summer.”

Our digital immunoassay POC system is currently being developed at a very fast pace in our UK subsidiary Psyros. The patent-pending digital immunoassay, where every molecule is counted, enables biomarkers to be detected at extremely low concentrations with high sensitivity and precision. We now have a highly motivated and competent team that has developed six functional instrument prototypes in a very short time. The team strongly believes that this new, ground-breaking POC platform will significantly benefit patients and the rapidly growing market for near-patient testing.

During the quarter, we received reproducible results from a proof-of-performance study confirming that our highly sensitive, digital immunoassay can detect exceedingly low levels of a specific protein, Thyroid Stimulating Hormone (TSH), in human plasma. These low measured concentration levels are, in turn, within the range required to detect and rule out a myocardial infarction with high-sensitivity troponin under current guidelines[1]. These results are an important milestone and bode well for the further development of a high-sensitivity assay for digital detection of troponin, but also for the development of further clinical tests in other major indication areas. The next important milestone is proof-of-performance, specifically for troponin, which we are working intensively to demonstrate before summer 2023.

After the end of the quarter, we were pleased to announce that we had met or exceeded all milestones for the second phase of the SBRI Healthcare grant, primarily by producing functional prototypes of the instrument. Psyros received the grant of around £1 million last year, conditional on achieving certain milestones this year. The grant has accelerated the development of our unique digital immunoassay.

To further accelerate the development, we have signed an agreement with a subcontractor for the industrialisation of the device. In parallel, our ambition is to set up the first parts of a development production line for cartridge manufacturing on our own premises.

Development work is proceeding according to plan, and we focus on further developing the unique digital technology, including additional data generation and advancement of our prototype system for instruments and cartridge. To raise awareness of our digital immunoassay concept, we aim to showcase it in July 2023 at the American Association for Clinical Chemistry (AACC) international congress, which is considered one of the largest among industry experts.

After the end of the quarter, we were pleased to announce that our technology and development partner, The Technology Partnership (TTP), reached a positive milestone in the development project in distributed testing for the PLD MicroFlex POC platform, with the transfer of two laboratory-based diagnostic tests to the platform. The development project is the first step in demonstrating that the platform can be adapted for existing tests currently implemented in central laboratories without making significant chemical changes. TTP is now working on identifying a suitable commercial partner to take the technology to market. During the quarter, we signed a commercialisation agreement with TTP for the PLD MicroFlex POC platform to continue development and pursue ongoing external initiatives and discussions. Under this agreement, remuneration to Prolight will be paid as future revenues are generated. We still believe strongly in the MicroFlex technology but prioritise our resources on our unique product platform for digital immunoassay.

Overall, our ground-breaking product platform for digital immunoassay has enormous potential. The platform may become the first digital, ultra-sensitive, portable POC platform for testing high-sensitivity troponin and eventually for performing many other clinical tests in large indication areas. The system is also very easily operated and has low production costs making it incredibly cost-effective, just what the market demands. Our strong team is highly motivated to do its utmost to deliver the best POC systems to healthcare providers and patients in the rapidly growing point-of-care testing market.
Lund in February 2023
Ulf Bladin, CEO Prolight Diagnostics AB (publ)

[1] European Cardiology Society´s Guidelines on Fourth Universal Definition of Myocardial infarction.