Prolight Diagnostics

Prolight Diagnostics, developer of the digital point-of-care platform Psyros™, has appointed MDx CRO as its contract research partner for the clinical performance study to validate the Psyros™ high-sensitivity 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. MDx CRO will be responsible for the preparation and execution of the upcoming multi-site clinical study of the commercial POC system, which is planned to start in early 2025. The clinical evaluation of performance, reliability and ease-of-use will be the basis for regulatory submission and approval, followed by the planned commercial launch in early 2026.
 
“With MDx, we have gained an extremely experienced and responsive partner with deep sector knowledge and high expertise. They have a truly solid and extensive research capability and we consider them to be the ideal partner for our continued product journey. The work to prepare for the validation is now underway. We are convinced that the successful validation of Psyros will represent a significant milestone for the diagnosis and management of myocardial infarction,” says Ulf Bladin, CEO of Prolight Diagnostics.
 
“We are excited to partner with Prolight Diagnostics, whose innovative approach to point of care diagnostics perfectly complements our strategic goals,” says Carlos Galamba, Founder of MDx CRO.