Prolight Diagnostics selects partner to conduct clinical validation studies
Prolight Diagnostics has appointed MDx CRO to perform clinical validation studies with the company’s digital point-of-care analysis system, Psyros, for high sensitivity troponin testing. The clinical validation is planned to start in early 2025 and is expected to form the basis for IVDR approval and commerical launch.
– With MDx, we have gained an extremely experienced and responsive partner with deep sector knowledge and high expertise, says CEO Ulf Bladin.
Prolight Diagnostics is developing a highly sensitive point-of-care analysis (POC) system, Psyros, capable of counting single molecules digitally. The initial product launch will focus on troponin analysis, which is of great clinical importance for detecting or ruling out a suspected myocardial infarction early in the healthcare chain.
The company’s POC system is also prepared to simultaneously measure multiple biomarkers, known as multiplex. The POC platform will be able to be used for measurement and analysis of several biomarkers in many different clinical areas.
MDx CRO will perform the validation studies
The company has just finalised the cartridge design for commercial use and is now planning for clinical performance studies in 2025. Yesterday, Prolight announced that they have appointed MDx CRO to perform clinical validation studies regarding the clinical performance of the Psyros highly sensitive troponin test.
– After a rigorous selection process, Prolight is pleased to announce the appointment of MDxCRO as its clinical partner. The collaboration will focus on the clinical validation of Prolight’s ground-breaking high-sensitivity troponin test, the company writes in a press release.
MDx CRO is a globally recognised Contract Research Organisation specialising in clinical trials for diagnostics.
– They have a truly solid and extensive research capability, and we consider them to be the ideal partner for our continued product journey, says Ulf Bladin.
Planned start in 2025
MDx CRO will be responsible for the preparation and execution of the upcoming multi-site clinical study for high-sensitivity troponin testing with the Psyros system, which is planned to start in early 2025.
The clinical validation will evaluate performance, reliability and ease-of-use and is expected to form the basis for a regulatory submission and approval under IVDR (In Vitro Diagnostic Medical Device Regulation), followed by the planned commercial launch in early 2026.
In the press release, Ulf Bladin writes that the clinical validation of Psyros may represent a significant milestone for the diagnosis and management of myocardial infarction. Carlos Galamba, founder of MDx CRO, is also looking forward to contributing to this milestone:
– We are excited to partner with Prolight Diagnostics, whose innovative approach to point of care diagnostics perfectly complements our strategic goals.
– MDx CRO’s reputation for excellence and their comprehensive research capabilities and specialising in regulatory compliance make them the ideal partner for this critical phase of our product’s journey, CEO Ulf Bladin concludes.
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