Prolight Diagnostics AB (publ), developer of the digital point-of-care platform Psyros™, today announces the finalization of the cartridge design to be used on the commercial platform.
Now, the process of design transfer to Prolight’s contract manufacturing partner Flex Medical Solutions begins. Flex Medical will use the design for the pilot manufacturing processes which shall be be ready for internal validation by the end of 2024, ahead of the clinical validation during 2025.
“This marks a major milestone in our product development and allows us to continue with assay performance evaluation. The simple design has many advantages, but most importantly, it allows us to be competitive on cost. Initially, this paves the way for a sought-after low-cost POC system for measuring high-sensitivity troponin in a drop of blood to rule-in, or rule-out, myocardial infarction”, said Ulf Bladin, CEO of Prolight.
The cartridge has a number of key competitive features including:
• Simple low part count design and designed for manufacture at large scale to ensure a competitive low cost of goods.
• Contains all the reagents required to complete the test with dried cartridge chemistry to avoid the complexity and cost of expensive liquid reagents/blister packs.
• Ergonomically designed for ease of use.
• Compatible with venous and capillary blood (fingerstick), and plasma samples.
• Multiplex capable to measure multiple analytes on a single cartridge.
