Prolight Diagnostics advances towards validation of test for myocardial infarction diagnostics
Prolight Diagnostics’ report for the second quarter marks significant progress in developing the point-of-care analysis system Psyros. Not least, the company received a British grant of SEK 17 million, allowing them to initiate a pre-validation study on whole blood samples from patients with suspected myocardial infarction. The first results from the study are expected in the fourth quarter of 2024.
Prolight Diagnostics develops a point-of-care analysis system to detect or rule out myocardial infarction at an early stage by measuring troponin in the blood. The company’s digital and portable Point-of-Care (POC) platform, Psyros, is capable of counting individual molecules of troponin allowing for high sensitivity and accuracy.
The company’s report for the second quarter highlights the British government grant of SEK 17 million, received in May from the NIHR Invention for Innovation (i4i) Product Development Award (PDA).
Preparing for validation
With the grant, the company can initiate a study at St Thomas’ Hospital and King’s College London, with the goal of pre-validating the performance of the POC platform. In the study, Psyros will be used to analyse whole blood from patients seeking emergency care with chest pain and suspected myocardial infarction. In addition, the plan is to analyse a large number of blood samples from a biobank with saved samples from patients with chest pain and confirmed myocardial infarction, as well as from healthy individuals.
The first results from the patient samples are expected to be available in Q4 2024. The data from the pre-validation study will be used to further develop and optimize the platform for the multicenter 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, potentially paving the way for a commercial launch in early 2026.
Technical development milestones
During the second quarter, the company also made several key advancements in the technical development of the system. In collaboration with G&H | ITL, the company has been working on developing final components to be able to start production of beta prototypes of the instrument. The prototypes are expected to undergo testing, evaluation and verification of regulatory compliance during the third quarter of 2024, before transitioning to manufacturing.
In addition, the company has completed the commercial design for the cartridge with its partner Flex Medical Solutions. The test card features a simple design with few components and is designed for large-scale manufacturing. In addition, the cartridge measure several biomarkers simultaneously from a drop of blood, so-called multiplex measurement. Data show that the cartridge complies with the requirements for ruling out myocardial infarction and risk stratification of patients with symptoms of myocardial infarction.
Growing interest from potential partners
As the development of Psyros progresses, so does the interest from potential partners, especially after the company’s participation at the ADLM Congress in Chicago. This congress gathered more than 20,000 participants from around the globe and gave Prolight Diagnostics opportunities to present its latest instrument prototype and the commercial disposable cartridge. Read more here.
During the congress, Prolight Diagnostics held several meetings with leading global diagnostics companies with plans to have follow-up partnership meetings in the near future.
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