Diagnostics firm Prolight’s novel point-of-care Psyros system has reached the prototype stage, the company has announced.
It has received the first of thirty full commercial prototype instruments from its development partner G&H I ITL, in readiness for a pre-validation study and subsequent clinical performance study in 2025, inline with the timeline towards commercial launch in 2026.
“This means that we will have a significant number of commercial prototypes up and running at our laboratories in December, which is a massive technical milestone,” commented Paul Monaghan, Head of Engineering at Prolight. “After passing our rigorous stress-testing, these commercial prototypes will be used in the pre-validation study for the final fine tuning of the Psyros test and platform. This will ensure the final commercial design is robust ahead of the transfer to production and the subsequent clinical performance study next year.”
Ulf Bladin, CEO of Prolight, added: “We are eager to begin testing with these commercial prototypes which will be used in our pre-validation study from which we expect the first results in Q1 2025. Those results will minimise risks and help ensure an optimal outcome for the subsequent multi-centre clinical performance study in 2025. Thus, we are in line with the overriding timeline, where the clinical performance study results will provide the basis for a IVDR regulatory application, paving the way for the commercial launch of our high-sensitivity troponin test in 2026.”
In total, the pre-validation study comprises of approximately 1,200 frozen biobank plasma samples and fresh whole blood samples from approximately 120 cardiac patients at St. Thomas’ Hospital in London, UK. The launch product on the Psyros system will be for the measurement of troponin, to aid in the rule-in and rule-out of myocardial infarction.