Prolight Diagnostics is developing a patient-friendly analysis system for early detection or exclusion of heart attacks by measuring troponin in the blood. The company's digital and portable Point-of-Care (POC) platform, Psyros, can count individual molecules of troponin, allowing for high sensitivity and accuracy.
The recently published report for the second quarter highlights, among other things, the British government grant of SEK 17 million received in May from NIHR Invention for Innovation (i4i) Product Development Award (PDA).
Preparing for validation
With the grant, the company can begin a study at St Thomas' Hospital and King's College London, with the goal of pre-validating the performance of the POC platform. The study will use Psyros to analyze whole blood from patients seeking emergency care with chest pain and suspected myocardial infarction. In addition, it is planned to analyze a large number of blood samples from a biobank with stored samples from patients with chest pain and confirmed myocardial infarction, as well as from healthy individuals.
The first results from patient samples are expected to be available in Q4 2024. Data from the pre-validation study will be used for further development and optimization of the platform ahead of the multi-center clinical study, which will be conducted by MDx CRO starting in early 2025.
This study is expected to form the basis for a regulatory application, which could pave the way for a commercial launch in early 2026.
Development milestones
During the second quarter, the company has also made several advances in the technical development of the system. In collaboration with G&H | ITL The company has been working to develop final components to begin production of beta prototypes of the instrument. The prototypes are expected to undergo testing, evaluation and compliance verification in the third quarter of 2024 before moving into manufacturing.
In addition, the company has completed the commercial design for the test card together with its partner Flex Medical Solutions. The test card has a simple design with few parts and is designed for large-scale manufacturing. In addition, the test card can measure several biomarkers simultaneously from a drop of blood, so-called multiplex measurement. Data show that the test card complies with the requirements for excluding myocardial infarction and risk stratification in case of symptoms of myocardial infarction.
Potential partners show interest
As the development of Psyros progresses, interest from potential partners is also increasing, especially after the company's participation at the international diagnostics congress ADLM Congress in Chicago. The congress brought together more than 20 participants from around the world and gave Prolight Diagnostics the opportunity to present its latest instrument prototype and the commercial disposable test card. Read more here.
During the congress, several meetings were held with leading global diagnostics companies with whom the company plans to have follow-up partnership meetings. An important piece of the puzzle in the discussions will be the results of the pre-validation study, which is expected to be available by the end of the year.