Prolight Diagnostics

Prolight Diagnostics (“Prolight”), developer of the Psyros™ digital point-of-care (POC) system for high-sensitivity troponin, announces that the platform will be showcased at DxPxduring the international congress ADLM in Chicago July 28-August 1, 2024.

“We are very proud to present the latest commercial instrument prototype and the cartridge that will be used for high-sensitivity troponin assays. Given our unique POC digital immunoassay technology, which counts single molecules, we anticipate there will be great interest. Our technology provides a unique opportunity to test with high sensitivity and accuracy on a POC instrument in near-patient settings. We look forward to constructive conversations with potential commercial partners during the congress", says Ulf Bladin, CEO of Prolight.

The simple design of the commercial cartridge allows for large-scale manufacturing at a competitive low production cost. The instrument is currently in the beta prototypedevelopment phase and is expected to undergo evaluation and verification in the third quarter of 2024, followed by transfer to manufacturing in Q4. A multicenter clinical performance study is planned to start in early 2025. The results from this study will form the basis of a regulatory submission ahead of clearance and commercial launch in early 2026.

Prolight's new innovative single-molecule counting technology opens up the possibility of performing new tests in near-patient settings for a number of different clinical areas that were previously only possible to carry out in specialized laboratories.

The innovative Psyros™ technology makes it possible to test a broad spectrum of differentbiomarkers with high sensitivity and accuracy on the same POC instrument. With the built-in multiplex function, it is also possible to test combinations of biomarkers for disease-specific panels from the same drop of blood. This could lead to a paradigm shift in near-patient testing that could ultimately transform care pathways for patients and lead to major health economic benefits.

About ADLM
ADLM (Association for Diagnostics & Laboratory Medicine), formerly AACC (American Association for Clinical Chemistry) Annual Scientific Meeting & Clinical Lab Expo, is considered one of the world's most important diagnostic congresses and brings together clinicians and laboratory specialists from all over the world.

About DxPx
The DxPx Industry + Investor Partnering Conference is the only dedicated Health Tech & Med Tech conference focused on diagnostics, digital health, precision medicine and life science tools. Today, DxPx has evolved into an established series of international partnering events and is an official partner of the ADLM 2024 conference.